5064 lines (5063 with data), 850.0 kB

Radiographic findings consistent with non-small cell lung cancer, including lesions with ground glass opacities with a solid component of 50% or greater; those with ground glass opacities and < 50% solid component will be excluded
Patients must be deemed surgically resectable by the surgical teams at each institution and must have a determination of degree of anticipated structure preservation of orbit and skull base; this needs to be determined prior to randomization
HIV plasma HIV-1 ribonucleic acid (RNA) below detected limit obtained by Food and Drug Administration (FDA)-approved assays (limit of detection: 75) within 4 weeks prior to registration
Patients must have biopsy-proven newly diagnosed polymorphic or monomorphic PTLD using the World Health Organization (WHO) classification and that is:\r\n* CD20 positive\r\n* EBV positive by Epstein-Barr virus early ribonucleic acid (RNA) (EBER) in situ hybridization (preferred) and/or LMP immunoperoxidase staining
Patients must be considered medically refractory to decreased immunosuppression (50% or greater reduction) for at least 1 week or there must be documentation in the medical chart that decreased immunosuppression would be associated with an unacceptable risk of rejection
Burkitt morphology
Fulminant PTLD defined as: fever > 38 degrees Celsius (C), hypotension, and evidence of multi-organ involvement/failure including two or more of the following: \r\n* Bone marrow (including pancytopenia without any detectable B-cell proliferation) \r\n* Liver (coagulopathy, transaminitis and/or hyperbilirubinemia)\r\n* Lungs (interstitial pneumonitis with or without pleural effusions)\r\n* Gastrointestinal hemorrhage
Participants must have previously untreated HIV-classical HL (cHL), with the exception of up to 14 consecutive days of steroids, emergency radiation, or 1 prior cycle of cyclophosphamide to reduce tumor burden and improve hyperbilirubinemia in the setting of lymphoma related liver involvement
Unsuitable for or refractory to transarterial hepatic chemo-embolization (TACE) or drug eluting beads (DEB) for any of the following reasons, as described by Raoul et al (2011):\r\n* Technical contraindications: arteriovenous fistula, including surgical portosystemic shunt or spontaneous portosystemic shunt\r\n* Severe reduction in portal vein flow: due to tumor portal vein, IVC or atrial invasion or bland portal vein occlusion\r\n* Medical contraindications including congestive heart failure, angina, severe peripheral vascular disease\r\n* Presence of extrahepatic disease\r\n* No response post TACE (or DEB) or progressive HCC despite TACE; prior TACE or DEB is allowed but must be > 28 days from study entry\r\n* Serious toxicity following prior TACE (or DEB); prior TACE or DEB must be > 28 days from study entry\r\n* Other medical comorbidities making TACE (or DEB) unsafe and/or risky (e.g. combination of relative contraindications including age > 80 years, tumor > 10 cm, > 50% replacement of the liver by HCC, extensive multinodular bilobar HCC, biliary drainage)
No known contraindication to peripheral blood stem cell (PBSC) collection; examples of contraindications might be a weight or size less than the collecting institution finds feasible, or a physical condition that would limit the ability of the child to undergo apheresis catheter placement (if necessary) and/or the apheresis procedure
Refractory cytopenia with multilineage dysplasia (RCMD)
Known 1p/19q co deletion
Multi focal (defined as 2 separate areas of contrast enhancement measuring at least 1 cm in 2 planes that are not contiguous on either fluid attenuated inversion recovery (FLAIR) or T2 sequences);
Associated with either diffuse subependymal or leptomeningeal dissemination; or
Presence of tumor(s) invading into the heart or great vessels (including carotid artery) or another location where bleeding is associated with high morbidity including patients with primary cardiac or great vessel angiosarcoma
Medulloblastoma or medulloblastoma variants including posterior fossa primitive neuroectodermal tumor (PNET) as documented by an institutional pathologist
NEUROCOGNITIVE REMEDIATION INTERVENTION
Patients with known cardiopulmonary disease are not eligible; cardiopulmonary disease is defined as:\r\n* Cardiomyopathy other than chemotherapy related changes in cardiac function that meet the eligibility requirements\r\n* Clinically significant arrhythmia:\r\n** History of polymorphic ventricular fibrillation or torsade de pointes,\r\n** Permanent atrial fibrillation (a fib), defined as continuous a fib for >= 6 months,\r\n** Persistent a fib, defined as sustained a fib lasting > 7 days and/or requiring cardioversion in the 4 weeks before screening,\r\n** Grade 3 a fib defined as symptomatic and incompletely controlled medically, or controlled with device (e.g. pacemaker), or ablation and\r\n** Patients with paroxysmal a fib or < grade (Gr) 3 a fib for period of at least 6 months are permitted to enroll provided that their rate is controlled on a stable regimen\r\n* Implantable cardioverter defibrillator;\r\n* Moderate to severe aortic and/or mitral stenosis or other valvulopathy (ongoing);\r\n* Pulmonary hypertension\r\n* Congestive heart failure class III or IV
Patients who are receiving any investigational agent other than pevonedistat, including but not limited to androgens, supraphysiologic doses of corticosteroids, erythropoietin, eltrombopag, or romiplostim
ADH/borderline DCIS
Absence of invasion or microinvasion
Papillary or micropapillary DCIS
Bloody nipple discharge
Self-reported ability to walk at least 2 blocks (at any pace)
Patients with a prior history of gastric/duodenal ulcers documented on endoscopy can be enrolled as long as the ulcers did not cause bleeding requiring a blood transfusion/major intervention; for patients who are Helicobacter pylori positive, a course of Helicobacter pylori eradication treatment must have been completed
Patients must have been assigned to S1400F
Granulocytes >= 1,500/ul
Patients are eligible under ONE of the following criteria:\r\n* Patients must have histologically confirmed rare cancer and must be able to submit specimens; NOTE: Subsequent to site’s Institutional Review Board (IRB) approval of revision 3, patients are NOT required to participate in EAY131 “National Cancer Institute (NCI)-Molecular Analysis for Therapy Choice (MATCH)” to register to this study\r\n* FOR PATIENTS ENROLLED IN EAY131 “NCI-MATCH” PRIOR TO EAY131 ADDENDUM 10 ONLY: Patients must have histologically confirmed rare cancer that did not have a match to a molecularly-guided therapy on EAY131 “NCI-MATCH” protocol or who are off protocol treatment on EAY131, “NCI-MATCH” and have no further molecularly-matched treatment recommendations per EAY131, “NCI-MATCH” or who are otherwise unable to receive EAY131, “NCI-MATCH” therapy
Patients must have adequate adrenal axis function, as evidenced by adrenocorticotropic hormone (ACTH) values within the institutional normal ranges OR cortisol levels within institutional normal ranges (ante meridiem [AM] cortisol preferred), within 28 days prior to registration
United States (U.S.) patients who can complete the survey and the interview by telephone or email in English must be offered participation in the S1400GEN survey ancillary study; NOTE: Patients enrolled to S1400 prior to revision #12 are not eligible for the S1400GEN survey ancillary study; study physicians will provide participants with a hard copy of the survey (at the time of informed consent) to improve tracking and comprehension during the interview
Granulocytes >= 1,500/ul
Results of central PD-L1 testing available; Q2 Solutions will forward the PD-L1 results to the statistical center and the statistical center will notify the site that the result is available; the notification from the Alliance registration/randomization office will serve as a confirmation of this eligibility criteria; after sites receive the confirmation e-mail from Alliance they can register the patient
Patients with new symptoms of congestive heart failure (CHF), cardiomyopathy, myocarditis, myocardial infarction (MI), or exposure to cardiotoxic medications must have a cardiology consultation, creatinine phosphokinase (CPK), and troponin testing at prestudy and as clinically indicated
Albumin, alkaline phosphatase, bicarbonate, blood urea (BUN), chloride, glucose, phosphorus, and total protein must be assessed within 28 days of registration
Patients must have a Ki-67 proliferative index of 20-100% OR at least 10 mitotic figures per 10 high powered fields
Patients must NOT have absorption issues that would limit the ability to absorb study agents
Tumors must have been completely resected; in patients with tumor adherent to adjacent structures, en bloc R0 resection must be documented in the operative report or otherwise confirmed by the surgeon; near or positive radial margins are acceptable so long as en bloc resection was performed. Proximal or distal margin positivity is not permitted
Based upon the operative report and other source documentation, the location of the primary tumor will be categorized as proximal or distal to the splenic flexure (distal includes), and further categorization will be as follows: cecum/ascending, descending, sigmoid colon, or rectosigmoid colon
Followed for cancer or survivorship care at one of the following institutions: \r\n* Dana Farber/Harvard Cancer Center\r\n* Hospital for Sick Children\r\n* Children’s Hospital of Eastern Ontario\r\n* Oregon Health and Science University\r\n* Seattle Children’s Hospital\r\n* Yale University
SR1 and SR2 patients:
Patients with postoperative fistula
Patients with uncontrolled hyperglycemia
Patients with uncontrolled hyperlipidemia
It is recommended that the starting and maintenance dose of rosuvastatin (due to BCRP inhibition by osimertinib) should be as low as possible and should be guided by the statin label; monitoring of low-density lipoprotein (LDL) cholesterol levels is advised; if the subject experiences any potentially relevant adverse events suggestive of muscle toxicity including unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever, the statin should be stopped, creatine kinase (CK) levels should be checked, and any appropriate further management should be taken
Eligibility criteria for the Longitudinal, Computerized Assessment of Neurocognitive Functioning study \r\n* Patients must be aged 6 to 13 years at time of B-ALL diagnosis, enrolled on AALL1131\r\n* Patients must be English-, French- or Spanish-speaking (languages in which the assessment is available)\r\n* Patients must have no known history of neurodevelopmental disorder prior to diagnosis of B-ALL (e.g., Down syndrome, Fragile X, William’s Syndrome, mental retardation)\r\n* Patients must have no significant visual impairment that would prevent computer use and recognition of the visual test stimuli
Effective March 19, 2018, patients enrolled on AALL0932, without Down syndrome, meeting the following criteria will NOT be eligible to continue on AALL0932 or the HR B-ALL stratum of this study at the end of Induction: \r\n* Without favorable cytogenetics (no ETV6-RUNX1 or double trisomies 4+10), with day 8 peripheral blood (PB) minimal residual disease (MRD) >= 1% and day 29 BM MRD < 0.01%\r\n* With favorable cytogenetics (ETV6-RUNX1 or double trisomies 4+10), with any day 8 PB MRD and day 29 bone marrow (BM) MRD >= 0.01%\r\n* Both NCI standard risk (SR) and HR patients without Down syndrome and with testicular disease at diagnosis, who do not meet other VHR criteria
Effective Amendment 6, patients enrolled on AALL0932, without Down syndrome, meeting the following criteria will NOT be eligible to continue on AALL0932 or the VHR stratum of AALL1131: \r\n* Intrachromosomal amplification of chromosome 21 (iAMP21)\r\n* Mixed-lineage leukemia (MLL) rearrangement\r\n* Hypodiploidy (n < 44 chromosomes and/or a deoxyribonucleic acid [DNA] index < 0.81) \r\n* Induction failure (M3 BM at day 29)\r\n* Without favorable cytogenetics (no ETV6-RUNX1 or double trisomies 4+10), with day 29 BM MRD >= 0.01%
Patients must have newly diagnosed v-myc avian myelocytomatosis viral oncogene neuroblastoma derived homolog (MYCN) non-amplified neuroblastoma (International Classification of Diseases for Oncology [ICD-O] morphology 9500/3) or MYCN non-amplified ganglioneuroblastoma verified by histology
Patients must meet the specified criteria for one of the treatment groups defined below; genomic features include MYCN gene amplification, segmental chromosome aberrations (somatic copy number loss at 1p, 3p, 4p, or 11q or somatic copy number gain at 1q, 2p, or 17q) and deoxyribonucleic acid (DNA) index\r\n* “Favorable” genomic features are defined by one or more whole-chromosome gains or hyperdiploid tumor (DNA index > 1) in the absence of segmental chromosome aberrations as defined above\r\n* “Unfavorable” genomic features are defined by the presence of any segmental chromosome aberration (somatic copy number loss at 1p, 3p, 4p, or 11q or somatic copy number gain at 1q, 2p, or 17q) or diploid tumor (DNA index = 1); this includes copy neutral loss of heterozygosity (LOH)\r\n* Only patients with MYCN non-amplified tumors are eligible for this study
Group B and C patients who do not enroll on ANBL1232 within 4 weeks of definitive diagnostic procedure
Institution has received results from Adaptive Biotechnologies as defined by one of the following criteria:\r\n* Patients are “MRD Indeterminate”: ClonoSEQ ID molecular marker assessment did not identify any unique clonal immunoglobulin DNA sequence OR\r\n* ClonoSEQ ID molecular marker assessment identified unique clonal immunoglobulin DNA sequence and MRD assessment is completed
If the RQ-PCR results are known at the time of study enrollment, the patient must demonstrate the PML-RARalpha transcript by RQ-PCR to be eligible
Determination of activated B-cell–like (ABC) subtype by pre-registration central review
Patients with vulvar melanomas or sarcomas
Patients with undetectable pre-treatment plasma EBV DNA
There are no restrictions on distance between the metastases
pN0 or pNx
Patients must not be known to be allergic to Chinese hamster egg or ovaries
Patients must have no evidence of upper tract (renal pelvis or ureters) cancer confirmed by one of the following tests performed within 90 days prior to registration: CT urogram, intravenous pyelogram, magnetic resonance (MR) urogram, or retrograde pyelograms
Patients must be PPD negative within 90 days prior to registration; PPD negativity is defined as < 10 mm diameter induration (palpable, raised hardened area) in the volar forearm at 48-72 hours following injection with standard tuberculin dose (5 units, 0.1 ml); for PPD readings done outside of 48-72 hour window, patients must have PPD test and reading repeated to confirm eligibility
Patient must undergo video-assisted thoracoscopic surgery and diagnostic laparoscopy within 28 days prior to step 1 registration; patients must undergo the diagnostic laparoscopy to rule out peritoneal disease spread
Patients must not have testicular involvement; if clinical or ultrasound findings are equivocal, biopsy must be performed; all tests for establishing testicular involvement must be completed within 14 days prior to registration
Patients must have specimens submitted for blinatumomab immunogenicity assessment; collection of pretreatment specimens must be completed within 28 days prior to registration to S1318; specimens must be submitted to LabConnect
Patients must agree to have specimens submitted for blinatumomab immunogenicity testing if subsequently moved to a blinatumomab containing treatment regimen on protocol
Prior WBRT
Must have evidence of progressive or recurrent GCT (measurable or non-measurable) following one line of cisplatin-based chemotherapy, defined as meeting at least one of the following criteria:\r\n* Tumor biopsy of new or growing or unresectable lesions demonstrating viable non-teratomatous GCT (enrollment on this study for adjuvant treatment after macroscopically complete resection of viable GCT is not allowed); in the event of an incomplete gross resection where viable GCT is found, patients will be considered eligible for the study\r\n* Consecutive elevated serum tumor markers (HCG or AFP) that are increasing; increase of an elevated lactate dehydrogenase (LDH) alone does not constitute progressive disease\r\n* Development of new or enlarging lesions in the setting of persistently elevated HCG or AFP, even if the HCG and AFP are not continuing to increase
No secondary somatic malignancy arising from teratoma (e.g., teratoma with malignant transformation) when it is actively part of the disease recurrence or progression
Cutaneous T cell lymphomas except transformed mycosis fungoides (MF)
Presence of grade > 2 peripheral neuropathy or patients with the demyelinating form of Charcot-Marie-Tooth syndrome
Diagnosis: Subjects must have a diagnosis of neuroblastoma or ganglioneuroblastoma (nodular or intermixed) verified by histology or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites. Subjects with the following disease stages at diagnosis are eligible, if they meet the other specified criteria: a) Subjects with newly diagnosed neuroblastoma with INSS Stage 4 are eligible with the following: i. Age > 18 months (> 547 days) regardless of biologic features or ii. Age 12-18 months (365-547 days) with any of the following 3 unfavorable biologic features (MYCN amplification, unfavorable pathology and/or DNA index = 1) or iii. MYCN amplification (> 4-fold increase in MYCN signals as compared to reference signals), regardless of age or additional biologic features. b) Subjects with newly diagnosed neuroblastoma with INSS Stage 3 are eligible with the following: i. MYCN amplification (> 4-fold increase in MYCN signals as compared to reference signals), regardless of age or additional biologic features or ii. Age > 18 months (> 547 days) with unfavorable pathology, regardless of MYCN status. c) Subjects with newly diagnosed neuroblastoma with INSS Stage 2A/2B with MYCN amplification (> 4-fold increase in MYCN signals as compared to reference signals), regardless of age or additional biologic features.
Specimens will be obtained only in a non-significant risk manner and not solely for the purpose of investigational testing.
Ability to tolerate PBSC collection: No known contraindication to PBSC collection. Examples of contraindications would include a weight or size less than that determined to be feasible at the collecting institution, or a physical condition that would limit the ability of the child to undergo apheresis catheter placement (if necessary) and/or the apheresis procedure.
Unresolved post-surgical complications (eg, significant infection) with healing difficulties
Measurable PVNS/dt-TGCT by RECIST 1.1 on MRI
Germ cell tumor (GCTs), excluding immature teratoma, or teratoma with malignant transformation.
For Phase 2, must have one of the following tumor types: recurrent or refractory NSCLC (any histology), or HCC with elevated alpha-fetoprotein (AFP) ?200 nanogram/milliliter (ng/mL).
Have a viral load <100 international units/milliliter (IU/mL).
For hepatitis B participants, must be on a nucleoside analog reverse transcriptase inhibitor (lamivudine, telbivudine, adefovir, tenofovir, or entecavir).
Patients with tumors to be injected lying close to an airway, major blood vessel or spinal cord that, in the opinion of the Investigator, could cause occlusion or compression in the case of tumor swelling or erosion into a major vessel in the case of necrosis. Patients with lesions in mucosal areas (vulvar, anus, oral cavity, etc.), are eligible, as long as the subject has at least one lesion suitable for injection; consult Medical Monitor for confirmation.
Patient is non-responsive to, refractory to, or intolerant of ESAs, or ESAs are contraindicated or unavailable, or a documented serum erythropoietin level of > 500 U/L.
Inability to comply with dietary restrictions for foods, supplements, and medications with potential for adverse interactions with phenelzine or to otherwise cooperate fully with the investigator and study personnel
Specimens will be obtained only in a non-significant risk manner and not solely for the purpose of investigational testing.
leukemia in 1st relapse following ? 1 unsuccessful salvage attempts,
Patients with a history of another malignancy within 3 years of the baseline visit. (Patients with cutaneous carcinomas or in-situ carcinomas will be considered for study entry on a case-by-case basis).
Ability to hold their breath for > 20 seconds for 5 times
Patients able to have bronchoscopic placement of Calypso transponders as confirmed on a recent (within the past 8 weeks) CT scan
Posterior lesions that would be > 19 cm distance from Calypso detector plate; patients may be treated in the prone position in order to meet the required minimum distance
Tumours that are known to have genomic alterations in PTEN or PIK3CB by local test results may also be eligible. Part B - Tumour amenable to taking of paired biopsies in opinion of the investigator.Patients with TNBC or mCRPC: PTEN-deficient tumours Parts A,B or D1(mCRPC)
Abnormal ECHO or MUGA at baseline <55%.
-  INCLUSION CRITERIA:\n\n          -  Patients of any age or either gender with indications for receipt of investigational\n             HPC-CORD BLOOD who are participating in an NIH-IRB approved clinical trial for\n             unrelated hematopoietic stem cell transplantation.\n\n          -  Signed informed consent (and assent when applicable).\n\n        EXCLUSION CRITERIA:\n\n          -  Patients who are receiving licensed CB products (only)\n\n          -  Patients who are receiving unlicensed CB products from other CB banks (i.e. NMDP)
HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or confirmed by HIV-1 antigen or plasma HIV-1 ribonucleic acid (RNA) viral load > 1,000 copies/mL\r\n* NOTE: the term \licensed\ refers to a United States (U.S.) Food and Drug Administration (FDA)-approved kit or for sites located in countries other than the United States, a kit that has been certified or licensed by an oversight body within that country and validated internally\r\n* WHO (World Health Organization) and CDC (Centers for Disease Control and Prevention) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment; a reactive initial rapid test should be confirmed by either another type of rapid assay or an E/CIA that is based on a different antigen preparation and/or different test principle (e.g., indirect versus competitive), or a Western blot or a plasma HIV-1 RNA viral load
Pathology slides from tumor tissue obtained by surgical excision or core biopsy must be reviewed by the designated site pathologist, or backup pathologist, prior to study entry; confirmation of the diagnosis must be documented by the AMC-approved pathologist prior to study entry; please reference the AMC-068 Manual of Procedures (MOP) for further instructions on documenting the diagnosis; the site pathologist for non-Hodgkin lymphoma (NHL) must be approved through the AMC's external quality assurance (EQA) process
Patients with a rhabdomyosarcoma will be excluded
Based on surgeon's assessment, patient is recommended to undergo cytoreduction surgery via laparotomy with the operative goal of this procedure to achieve optimal cytoreduction to less than 1 cm of residual disease
Plan for exploratory laparoscopy prior to laparotomy for assessment of disease resectability
Surgeon has high suspicion (> 50% chance) that cytoreduction surgery will be aborted due to inability to achieve optional cytoreduction to < 1 cm residual disease
Patients with any disease that will obscure toxicity or dangerously alter drug metabolism
Active scleroderma or calcinosis cutis with features of Raynaud phenomenon, esophageal dysmotility, sclerodactyly, and telangiectasia (CREST) syndrome
Patients with poorly controlled hypertension on multiple antihypertensives
Subjects with radiographic signs of excessive intra-cranial mass effect with associated rapid neurologic deterioration, and/or spinal block, are unsafe to undergo BBBD chemotherapy and are not eligible
(For progression based solely on worsening of non-target or new, non-measurable disease) confirmation by an additional scan at least 4 weeks after the initial scan unless it is accompanied by correlative symptoms. In addition, all the following must hold:
Need for > 2 antihypertensive medications for management of hypertension (including diuretics).
Need for vasopressor or ventilatory support
Angioimmunoblastic T-cell lymphomas (AITL);
failed to achieve at least a partial response after 2 or more cycles;
progressed after an initial response
Requirement for insulin for routine diabetic management and control
Requirement for > 2 oral hypoglycemic medications for routine diabetic management and control
Active infectious disease considered by the Investigator to be incompatible with the protocol.
Have BSA involvement corresponding to stages IA, IB or IIA CTCL with at least 3 distinct lesions
Patients with history of neurofibromatosis (NF) may have other stable central nervous system (CNS) tumors (schwannoma, acoustic neuroma or ependymoma) if lesions have been stable for 6 months
Metastatic meningiomas (as defined by extracranial meningiomas) and meningioma with extra-cranial spread are allowed
Paranasal sinus/nasal cavity malignancy is considered unresectable with negative margins surgery or resection would be considered excessively morbid; this could include lesions with:\r\n* Carotid involvement\r\n* Cavernous sinus invasion\r\n* Brain invasion\r\n* Orbital apex\r\n* Intraconal space\r\n* Pterygoid musculature involvement\r\n* Invasion of the clivus
Screen serum erythropoietin level > 400 mIU/mL,
Bortezomib: 7 days
Combination/multi-agent cyto-reductive therapy
Erythropoietin or erythrocyte stimulating agents: 30 days
Eltrombopag, romiplostim or platelet stimulating agents: 30 days
Received >2 cycles of alkylating agent combinations.
Treatment within 30 days prior to enrollment/randomization with strong immune modulators including but not limited to systemic cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, methotrexate, azathioprine, rapamycin, thalidomide, and lenalidomide
Patient has a history of clinically significant dry eye (xerophthalmia) or other corneal abnormality, or if a contact lens wearer, does not agree to abstain from contact lens use from baseline through the last TVB-2640 dose
Must be able to take antithrombotic prophylaxis.
Known intolerance to IMiDs.
Non-active hepatitis B (HBsAg-, Anti-HBs+, Anti-HBc+) may be enrolled at the discretion of the investigator after consideration of risk of reactivation.
Patients with GBMs located in the following anatomical regions known to have magnetic susceptibility or poor signal will be excluded: mesial temporal lobe, orbitofrontal cortex, prefrontal cortex, medial frontal gyrus, brainstem, and cerebellum
Phase 2:\r\n* Cohort A: RET-positive NSCLC subjects must have received at least one prior line of therapy, but must be RET TKI-naive\r\n* Cohort B: RET-positive NSCLC that has previously been treated with one RET TKI; subjects cannot have received more than one prior RET TKI and must not have received prior alectinib\r\n* Cohort C: RET-positive thyroid cancer, must be radioactive iodine refractory
Primary surgical treatment is lumpectomy + SLNB or ALND --or-- mastectomy + ALND
Abnormal cardiac rhythm not controlled with medication; Hx of stroke within 1 year; Hx of coronary events and/or heart failure within 1 year.
Hx of drug-induced acute tubular necrosis.
Upon the identification of an MTD or RP2D, the Sponsor, in consultation with the study investigators, may open the enrollment of two of the following nonrandomized tumor specific extension cohorts:
Relapsed or refractory acute promyelocytic leukemia (APL), with no available therapies. Note: Prior exposure to arsenic trioxide is allowed; however, subjects who have failed arsenic trioxide within the last 12 months are not allowed.
ramucirumab
Total abstinence from sexual intercourse
Total abstinence from sexual intercourse
The Sponsor may decide to limit the specific tumor types selected or treatment settings for specific arms based on evidence gathered.
Participants receiving any medications or substances that are known to cause photosensitivity (e.g. tetracyclines, sulfonamides, phenothiazines, sulfonylurea hypoglycemic agents, thiazide diuretics, griseofulvin, fluoroquinolones, St. Johns' wort, amiodarone) are ineligible.
Wild-type TP53 status
Deletion of chromosome 17, or del(17p)
Known deficiencies or suspected defect in the urea cycle
Primitive peritoneal, pericardial and tunica vaginalis testis mesotheliomas
Agreement of both the Chow et al. and type of cancer, ECOG performance status, age, prior palliative chemotherapy, prior hospitalizations, and hepatic metastases (TEACHH) models, indicating a median life expectancy of > 3 months
Life expectancy of > 3 months as defined by agreement of both the Chow et al. and TEACHH models
Patients lacking the capacity to describe their symptoms are excluded
Subject is a female who is pregnant or breast-feeding, or intends to become pregnant during their participation in the study (including up to 6 months after the last dose of IMP) or is a male who intends to father a child during their participation in the study (including up to 6 months after the last dose of IMP);
Subject with any prior Grade ? 3 irAE to other therapeutic proteins or immunotherapy, and the reaction could not be controlled or prevented on subsequent infusion with standard therapies such as antihistamines, 5-hydroxytryptamine antagonists, or corticosteroids;
AGS62P1
L-Histidine base
L-Histidine HCl
?, ? -Trehalose Dihydrate
Prior ACT infusion within 6 months of study enrollment (cohorts include ACT with tumor infiltrating lymphocytes [TIL], human leukocyte antigen [HLA]-class I T cell receptor [TCR]-engineered lymphocytes, HLA-class II TCR-engineered lymphocytes, and chimeric antigen receptor [CAR]-engineered T cells)
Disease suitable for assessment by pre- and post-biopsies
Active treatment with medications that lower the seizure threshold which cannot be held: \r\n* Aminophylline/theophylline\r\n* Atypical antipsychotics (e.g., clozapine, olanzapine, risperidone, ziprasidone)\r\n* Bupropion\r\n* Lithium\r\n* Pethidine\r\n* Phenothiazine antipsychotics (e.g., chlorpromazine, mesoridazine, thioridazine)\r\n* Tricyclic and tetracyclic antidepressants (e.g., amitriptyline, desipramine, doxepin, imipramine, maprotiline, mirtazapine)
Receipt of a therapeutic anticoagulant
Common variable immunodeficiency
Known severe congenital or acquired cellular or humoral immunodeficient or immunocompromised patients
Dementia of any kind
Patients with symptomatic cholelithiasis
Must be unresponsive or refractory to erythropoiesis-stimulating agents (ESA), based on one of the following:
Transfusion-dependence in subjects previously treated with an ESA (requires a minimum ESA trial of > 40,000 U/week recombinant human erythropoietin (rHuEPO) x 8 weeks or equivalent dose of darbepoetin or other erythropoietin agent), or
Brain metastasis must not be impending herniation or other significant vasogenic edema requiring increasing steroid doses; lesions must not have frank hemorrhage
Uncontrolled angina - Canadian Cardiovascular Society grade II-IV despite medical therapy
Any number of prior recurrences are allowed
Patients with known inborn errors of metabolism of primary carnitine deficiency, carnitine palmitoyltransferase I or II deficiency, carnitine translocase deficiency, beta-oxidation defects, pyruvate carboxylase deficiency and porphyria
An echocardiographic finding of tricuspid valve regurgitant jet (TRJ) velocity ? 2.7 m/sec.
Serum conjugated (direct) bilirubin < 2x upper limit of normal for age as per local laboratory. Patients with hyperbilirubinemia as a consequence of hyperhemolysis, or who experience a sudden, profound change in the serum hemoglobin after a RBC transfusion are not excluded.
Lack of clinical or radiologic evidence of a recent neurologic event (such as stroke or transient ischemic attack) by Cerebral MRI/MRA within 30 days prior to initiating transplant conditioning. Subjects with clinical or radiologic evidence of a recent neurologic event will be deferred for ? 6 months with repeat cerebral MRI/MRA to ensure stabilization of the neurologic event prior to proceeding to transplantation
Have had cancer other than MB, NB, ES or RMS for Part A of the study or cancer other than MB in the previous 5 years for Parts A and B
Successfully pass the screening CPET by achieving: o Volitional exhaustion (RPE ? 9 using the 0-10 RPE scale) after 8 (or more) minutes, in the absence of any cardiorespiratory abnormalities.
Note: To assist practitioners with delivering valid CPET assessments, patients nearing exhaustion should achieve a respiratory exchange ratio (RER) of ?1.1.
Experiences shortness of breath, chest discomfort, or palpitations when performing activities of daily living
Patients with pure seminoma
Patients with pure teratoma
Osteoporosis (T-score of less than -2.5 by DEXA scan)
Karnofsky >70% (an attempt to quantify cancer patients' general well-being and activities of daily life. The score ranges from 0 to 100 where 100 is \perfect\ health and 0 is death.)
Unresolved irAEs following prior biological therapy, except that stable and managed irAEs may be acceptable (e.g., hypothyroidism or hypopituitarism on appropriate replacement).
Hepatobiliary diseases including biliary tract diseases, autoimmune hepatitis, inflammation, fibrosis, cirrhosis of liver caused by viral, alcohol, or genetic reasons; Gilbert’s disease is allowed if total bilirubin (TBil) is =< 1.5 x ULN
Subjects who have lesions within 2 cm of central structures, will be eligible on a case-by-case basis \r\n* Tumor within or touching the zone of the proximal bronchial tree, defined as a volume 2 cm in all directions around the proximal bronchial tree (carina, right and left main bronchi, right and left upper lobe bronchi, intermedius bronchus, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi)
Prior whole-lung or hemi-thorax irradiation of greater than 12 gray (Gy) received less than 6 months prior to consent (focal radiotherapy to the thorax is not an exclusion)
The AZD1775 plus olaparib and AZD2014 plus olaparib additional inclusion criteria will be added as addendums to the protocol and opened once the recommended phase II doses are available
The use of cannabis oil is prohibited during the first 2 cycles of this protocol; patients must be off of cannabis oil for 3 days prior to enrollment
Impaired wound healing or other extremity complications due to severe or uncontrolled diabetes mellitus in subjects whose Injectable Lesions are located in an extremity.
Prior exposure to drugs that are antagonists of colony stimulating factor-1 receptor (CSF1R) like but not limited to emactuzumab (RG7155) (Roche), PLX3397 (Plexicon), and JNJ40346627 (J & J)
Retinoblastoma protein (RB) positivity as defined by RB expression (score of 0.5 or 1) with concurrent p16in4a loss (score of 0-2)
Known brain/leptomengial involvement of the disease, active neurological disease, dementia
cMET amplification by FISH (GCN ? 6),
Suitable for treatment with nivolumab per package insert
Active mucositis
Radiologically documented evidence of major blood vessel invasion or encasement by cancer.
medications belonging to the class of sulfonamides, with the exception of sulfanilamides (e.g., sulfamethoxazole).
Not responding or failed treatment on AZA or decitabine (note they are also eligible if additionally they have failed another ESA after at least 4 cycles)
Responders who cease responding
Willing to agree to periodic contact with a member of the study team during the period that the cancer has not recurred and/or has not become platinum resistant
DONOR: ABO compatibility (in order of priority)\r\n* Compatible or minor ABO incompatibility\r\n* Major ABO incompatibility
Nottingham grade 1-2. Specifically, nuclear and mitotic scores must be less than or equal to 2.
Vasopressor requirement
Concurrent hepatic veno-occlusive disease (VOD) based on clinical examination
Biopsy proven MLS (including the reciprocal chromosomal translocation t(12;16)(q13;p11); A the primary sarcoma in case of non-metastatic disease for management is with curative intent (regimen to be chosen = 18 x 2 GY) B in case of oligometastatic patients, the metastasis may also be irradiated to a dose of 36 GY in order to postpone the time interval to next systemic chemotherapy. These patients are usually not operated upon and the total dose may also be reached in 12 times 3 Gy, for convenience purposes (see paragraph 10 for radiobiological considerations).
Anticoagulant medication of any kind; especially Ascal®(and derivates), coumarines (Sintrom® and Marcoumar®), all heparin and heparin-like formulations. (Note: this exclusion criterion only applies for patients consenting to the translational research part of the study; patients on anticoagulant medication as described above may take part in the dose reduction part of the study, but the repeat biopsies may not be taken.)
The following concomitant medications are not allowed during navitoclax administration: clopidogrel, ibuprofen, tirofiban, warfarin, and other anticoagulants, drugs, or herbal supplements that affect platelet function are excluded, with the exception of low-dose anticoagulation medications (such as heparin) that are used to maintain the patency of a central intravenous catheter; aspirin will not be allowed within 7 days prior to the first dose of navitoclax or during navitoclax administration; however, subjects who have previously received aspirin therapy for thrombosis prevention may resume a low dose (i.e., maximum 100 mg QD) of aspirin if platelet counts are stable (>= 50,000/mm^3) through 6 weeks of navitoclax administration; all decisions regarding treatment with aspirin therapy will be determined by the investigator in conjunction with the medical monitor
Patients much have a negative purified protein derivative (PPD) skin test and a negative Quantiferon assay or a tuberculosis (TB) T-spot test; indeterminate results, due to lack of response to the mitogen control reflecting their immunocompromised state, will be permitted
New immunosuppressive medication or extracorporeal photochemotherapy (ECP) within 28 days of starting treatment with abatacept
Diagnosis of extranodal NK/T lymphoma, per WHO classification, 4th ed., which must include EBV tumor positivity, measured either by EBV encoded RNA (EBER) or LMP1 immunostaining.
Hemophagocytic lymphohistiocytosis.
Mature B-cell (Burkitt's) ALL
Is willing to provide additional archived samples for comprehensive genomic and/or proteomic analyses if the subject has a partial response/complete response to DS-3032b treatment.
Prior vismodegib or other antagonists of the hedgehog (Hh) pathway
Patients must be considered to have an acceptable risk of early mortality with intensive chemotherapy as determined by the attending physician at the time of the initial visit; since the specific therapy within each arm will be determined after randomization, there is no threshold of organ dysfunction or performance status for inclusion
In cases of lymphoproliferative disease arising in patients who are pharmacologically immunosuppressed, reduction of immunosuppression (RI) must be attempted prior to or in conjunction with enrollment, with the exception of those for whom RI would pose excessive threat of clinically significant graft rejection (as judged by local investigator)\r\n* NOTE: Patients who are otherwise immunosuppressed (for reasons such as immune dysregulation related to autoimmune conditions, in the absence of pharmacological immunosuppression) may be eligible if, in the opinion of the treating investigator, the risk of immediate treatment with rituximab-cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone (R-CHOP) outweighs the benefit for these patients
NOTE: patients who do not meet the above criteria because of disease involvement of the organ in question, or because of acute systemic illness due to lymphoma, may enroll with permission of the study principal investigator (PI) and approval from the Data Monitoring Committee; this flexibility be allowed due to the heterogeneity of the patient population, the wide range of complications seen in the initial presentation of EBV-related malignancy, and the frequent difficulty encountered in attempting to clearly document that organ dysfunction is the result of an underlying lymphoproliferative disorder
In addition, patients with abnormal renal function may be included if the abnormal function is due to allograft dysfunction resulting from diagnosis of PTLD, or from reduction/cessation of immunosuppression aimed at treatment of PTLD
Treatment with a somatostatin analog (e.g., octreotide acetate) is required for all participants; octreotide naive patients may initiate this during the screening period or at start of study
No unhealed wounds, ulcers or bone fractures
Patients will be included if they have a National Comprehensive Cancer Network score for fatigue over 3 (NCCN > 3) as determined by the standard fatigue scale of 0-10 unless otherwise approved by the principle investigator or principal investigator's (PI’s) designee
Patients using over the counter supplements or other natural products within one week of treatment, excluding vitamins and calcium supplementation, or at the discretion of the enrolling physician, will be excluded
Patients will be asked to refrain from having more than one alcoholic beverage per day
Ability to begin treatment in the extension (rollover) protocol within 15 days following the last day of the study in the antecedent protocol
Adverse event requiring discontinuation of vemurafenib in the antecedent protocol
PIK3CA WILD TYPE AND MUTANT COHORT (closed 03/17/2016): Patients who were pre-registered to National Cancer Institute (NCI) 9170 trial (Phase II Trial of Neoadjuvant MK-2206 in Combination with either Anastrozole if Postmenopausal or Anastrozole and Goserelin if Premenopausal in Women with Clinical Stage 2 or 3 PIK3CA Mutant Estrogen Receptor Positive and HER2 Negative Invasive Breast Cancer), started anastrozole (or anastrozole plus goserelin if premenopausal) =< 6 weeks, and were found negative for PIK3CA hotspot mutations are eligible to be screened for the wild type cohort; in institutions without NCI 9170 open, or after completion of enrollment to NCI 9170 in institutions where it is open, patients will be pre-registered to this trial and those with PIK3CA mutations will be enrolled to the PIK3CA mutant cohort
PIK3CA MUTANT COHORT (closed 03/17/2016): In premenopausal women, serum estradiol level in postmenopausal range =< 7 days prior to registration
PIK3CA WILD TYPE COHORT (closed 03/17/2016): tumor PIK3CA mutation present\r\n* Note that if a patient did not have sufficient research tissue for PIK3CA sequencing at pre-registration or if PIK3CA sequencing result is delayed, she could be registered and enrolled on the PD991 trial without assigning to a particular cohort at the time of enrollment; PIK3CA sequencing will be performed in the future on tumors collected at subsequent time points to assign the treatment cohort or when the PIK3CA sequencing data is available
PIK3CA WILD TYPE COHORT (closed 03/17/2016): In premenopausal women, serum estradiol level in postmenopausal range =< 7 days prior to registration
Syncope without known aetiology within 3 months
Patients with central pulmonary metastases or recent hemoptysis (>= 1/2 tea spoon [tsp] of red blood) within 28 days of registration\r\n* Patients with clinically significant proteinuria (i.e. > grade 1) or urine protein to creatinine ratio (UPC) ratio above 1.0\r\n* Patients with suspicion of transmural tumor bowel involvement based on the investigator's discretion may not enroll on this study
Baseline fasting triglycerides > 2.5 IULN or hypertriglyceridemia requiring medication; patients requiring medication for other dyslipidemias (i.e., elevated low-density lipoprotein [LDL] cholesterol) are eligible
Baseline (pre-treatment) electrocardiogram (EKG) with any of the following changes consistent with cardiac ischemia:\r\n*Significant ST depression (ST depression of >= 2 mm, measured from isoelectric line to the ST segment at a point 60 msec from the end of the QRS complex)\r\n* Significant ST elevation (> 1mm in limb lead or 2 mm in precordial lead measured at a point 0.04 sec [1 mm] after the J-point [the end of the QRS complex] and compared to baseline [line drawn from P start to T end])\r\n* Investigators are encouraged to consult with cardiologists locally and with the study chair should any questions arise
Patients known to have germ-line adenomatous polyposis coli (APC) mutations or clinical manifestations of Familial Adenomatous Polyposis(FAP)/Gardner's syndrome can be included
Freckling in the axilla and/or inguinal region
Plexiform neurofibroma
Two or more Lisch nodules
A first-degree relative with NF1
Antibiotics: clarithromycin, erythromycin, troleandomycin
Antidepressants: nefazodone, fluvoxamine
Miscellaneous: amiodarone
If requires pheresis to collect blood, creatinine (Cre) < 1.5 upper limit of normal
Other serious illness(es) involving the cardiac, respiratory, CNS, renal, hepatic or hematological organ systems which might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study.
Patients with an autoimmune disorder of the central or peripheral nervous system will be eligible; this will include:\r\n* Primary Central Nervous System (CNS) vasculitis\t\r\n* Rasmussen’s encephalitis\r\n* Autoimmune peripheral neuropathy (anti-Hu [Anna-1], anti-GM1 [GD1b], anti-MAG, anti-ganglioside, anti-sulfatide)\r\n* Autoimmune cerebellar degeneration\r\n* Gait Ataxia with Late age Onset Polyneuropathy (GALOP)\r\n* Stiff Person Syndrome\r\n* Chronic Inflammatory Demyelinating Polyneuropathy\r\n* Myasthenia Gravis\r\n* Lambert-Eaton myasthenic syndrome\r\n* Human T-cell lymphotropic virus (HTLV)-1-associated myelopathy (HAM) / tropical spastic paraparesis (TSP)\r\n* Opsoclonus / myoclonus (anti-Ri)\r\n* Neuromyelitis optica\t\r\n* Multiple sclerosis (only patients with relapsing/remitting multiple sclerosis [MS] will be included)\r\n* Other central or peripheral nervous system autoimmune diseases as approved by study neurologists and the Fred Hutchinson Cancer Research Center (FHCRC) faculty at Patient Care Conference (PCC)
Receiving erythroid stimulating agents (erythropoietin [EPO]: Procrit, Aranesp)
Patients with carotid artery involvement or encasement will be allowed provided they have no symptoms related to carotid involvement
Recursive partitioning analysis (RPA) class III patients (expected to be treated less than 2 years from first course of therapy and have a tracheostomy or percutaneous endoscopic gastrostomy [PEG] tube at presentation)
Any dysphagia, odynophagia, esophageal dysmotility or stricture, known GI malabsorption syndrome, or intractable diarrhea that may significantly alter the absorption of any of the components of SM-88, e.g., cirrhosis.
Subjects with a history of the light sensitive diseases for which methoxsalen would be contraindicated. Diseases associated with photosensitivity include lupus erythematosus, porphyria cutanea tarda, erythropoietic protoporphyria, variegate porphyria, xeroderma pigmentosum, and albinism.
Subjects treated, or anticipated to be treated, with delavirdine (due to potential for loss of virologic response and possible resistance to delavirdine or to the class of non-nucleoside reverse transcriptase inhibitors caused by phenytoin).
Other acute leukemias that are of ambiguous lineage or of other types
CNS complications for whom urgent neurosurgical intervention is indicated (e.g., resection, shunt placement)
Have received radioimmunotherapy (eg, 131I-tositumomab, 90Y-ibritumomab tiuxetan) less than 6 weeks before the first dose of AG-270.
Are unable to take no food or liquids other than water for 2 hours before and 2 hours after each dose of AG-270.
ALL PHASES:
Inclusion of women, minorities, and other underrepresented populations: this protocol is open to males and females of all races
CNS complications for whom urgent neurosurgical intervention is indicated (e.g., resection, shunt placement)
Have known factors that may increase the risk of infection while on study drug treatment. These may include, but are not limited to, an indwelling peritoneal catheter or open wounds. Catheters for vascular access are permitted.
Serious nonmalignant disease
Prior exposure to isatuximab or participation in clinical studies with isatuximab.
Evidence of electrolyte imbalance
Must consent to provide biomarker analyses as described in the protocol.
Other locoregional therapy [e.g., radiofrequency ablation (RFA), TACE (transarterial chemoembolization), TARE (transarterial radioembolization), DEB-TACE (drug eluting bead transarterial chemoembolization)]: 6 weeks
A histologic diagnosis of salivary duct carcinoma (other subtypes of salivary gland cancer are excluded).
TNBC is defined as:
Human papillomavirus-negative HNSCC
Has a ROS1 translocation
Females with a histologically proven CAH/EIN or grade I endometrial carcinoma (EC) for which surgery is planned; the pathologic report from the referring facility will be used to determine pathologic eligibility; this report must be within 45 days of their baseline (pre-surgical) clinic visit
Received >100 mg/m2 equivalents of daunorubicin (see Appendix G for conversion table)
Life expectance of >= 3 months
Agree to ongoing pregnancy testing during the course of the study as outlined in the PPRMP.
Agree not to share IP with another person
Troponin-T value > 0.4 ng/mL or B-type natriuretic protein (BNP) > 300 pg/mL by central laboratory assessment Subjects with baseline troponin-T > ULN or BNP > 100 pg/mL are eligible but must have a cardiologist evaluation prior to enrollment in the trial for baseline assessment and optimization of cardioprotective therapy.
Need for > 2 antihypertensive medications for management of hypertension (including diuretics).
Nodal status - negative (Imaging of the axilla is negative; Imaging is suspicious or abnormal but the FNA or core biopsy of the questionable node[s] on imaging is negative)
LVEF assessment must be performed within 42 days prior to randomization. (LVEF assessment performed by echocardiogram is preferred; however, MUGA scan may be substituted based on institutional preferences.) The LVEF must be ? 55% regardless of the cardiac imaging facility's lower limit of normal.
All patients must have locoregional staging determined by endoscopic ultrasound (EUS) if technically feasible; endoscopy reports or subsequent gastrointestinal (GI) clinic note should clearly state both the T and N stage
Patients highly unlikely to undergo PD according to the surgeon’s judgment, such as conditions amenable to pancreas enucleation, ampullectomy, etc
Disease measurability:
Histopathologic evidence of cancer based upon pathologist's report.
Patients with nasopharyngeal carcinoma, salivary gland or skin primaries
N-terminal pro b-type natriuretic peptide (NT Pro-BNP) > 8500 pcg/mL
Concurrent exposure to any commercially available agents known to be active against SMM and MM
With the exception of low-dose aspirin, subjects enrolled in this study should not take concomitant medications that durably inhibit platelet function including marine oil tablets; for such medications a wash-out period of >= 7 days is required prior to starting treatment; agents which inhibit platelet function transiently or inhibit coagulation by other mechanisms are restricted (e.g. use with caution); medications that directly and durably inhibit platelet function include aspirin containing combinations, clopidogrel, dipyridamole, tirofiban, epoprostenol, eptifibatide, cilostazol, abciximab, ticlopidine, cilostazol
Women with only synthetic 2D mammograms generated from 3D (tomosynthesis) are excluded as breast density measurements are not yet validated for synthetic mammograms. Women with combination 2D+3D mammograms are not excluded.
Patients not capable of getting PET study due to weight, claustrophobia, or inability to lie still for the duration of the exam\r\n* For patients in the imaging correlate sub-study: An MRI will not be performed if there is contraindication for undergoing MRI based on University of California San Francisco (UCSF) Radiology guidelines
Any patient receiving treatment with short-acting octreotide, which cannot be interrupted for 48 hours before and 24 hours after the administration of yttrium Y 90-edotreotide (90Y-DOTA-TOC), or any patient receiving treatment with octreotide LAR or lanreotide, which cannot be interrupted for at least 4 weeks before the administration of 90Y-DOTA-TOC\r\n* Concurrent somatostatin receptor analog (SSA) allowed if progression has been documented and the SSA dose has been stable for at least two months; long-acting SSA cannot be given within four weeks of treatment and short-acting SSA cannot be given with 48 hours of treatment; SSA therapy can restart one day after treatment
Hemosiderosis/hemochromatosis
Acute leukemias of ambiguous lineage
Disease not amenable to curative or transplant surgery ([Barcelona Clinic Liver Cancer [BCLC] Stage B); disease must be reviewed by members of disease management team at the local enrolling institution and be amenable to deb-TACE to treat all sites of disease in one session; for the dose escalation, regional lymphadenopathy and sub-centimeter pulmonary nodules are allowed as well as segmental portal vein involvement
Baseline peripheral neuropathy >= grade 2 or patients with the demyelinating form of Charcot-Marie-Tooth syndrome
Patients must have a pathologically confirmed adenocarcinoma of the biliary tract (intra-hepatic, extra-hepatic [hilar, distal] or gall bladder) that is not eligible for curative resection, transplantation, or ablative therapies
Hepatopulmonary shunting < 20% as documented via hepatic artery perfusion study
Vascular abnormalities or bleeding diathesis that indicates hepatic artery catheterization is contraindicated
Patients with a condition related to their cancer or leptomeningeal disease requiring urgent intervention that has not been clinically managed or stabilized prior to the time of consent
Brain metastases with risk of mass effect that would contraindicate lumbar puncture
Diagnostic biopsy reveals perineural invasion (PNI) and/or lymphovascular invasion (LVI)
Trismus or compromised airway
History of orthotopic liver transplantation, hepatic vasculature incompatible with perfusion, hepatofugal flow in the portal vein or known unresolved venous shunting. Prior Whipple procedure is permitted provided the anatomy is still compatible for perfusion with the Melphalan/HDS system.
Patients with biliary stents.
All hormonal-acting agents (including diethylstilbestrol/DES, aldosterone, and spironolactone) must be discontinued before registration; no washout period will be required for any of these agents
Histologic or cytologic diagnosis of a WDNET, Ki67 =< 30%, unresectable, of foregut origin (thymic, bronchopulmonary, gastric, duodenal, and pancreatic) confirmed by the enrolling institution\r\n* Note: If patients have a functional NET, they are permitted to continue on a somatostatin analog for hormonal symptom control
Additional criteria for cohort D (anti-PD1 combo) will be supplied in an appendix at a later date.
Additional criteria for cohort D (anti-PD1 combo) will be supplied in an appendix at a later date.
Prior exposure to CWP232291.
Investigational site staff members directly involved in the conduct of the study and their family members, or Pfizer employees, including their family members, directly involved in the conduct of the study.
Spinal Instability Neoplastic score >= 7 unless lesion reviewed by a neurosurgical service and considered stable
Adequate oral intake/nutritional status without the need for enteral or parenteral feeding during chemoradiation or preoperative period
Radiation oncology consultation within 28 days to confirm that disease can be encompassed in the radiotherapy field and that normal tissue constraints can be met
Esophagogastrectomies will be performed via a laparotomy and a right thoracotomy with en-bloc removal of perigastric, celiac, periesophageal and subcarinal lymph nodes; esophagogastric reconstruction will be performed above the level of the azygo-caval junction using an end-to-end (EEA) stapling device
Treatment with the following medications are contraindicated with DSF: metronidazole, isoniazid, dronabinol, carbocisteine, lopinavir, paraldehyde, ritonavir, sertraline, tindazole, tizanidine, atazanavir.
At Massachusetts General Hospital (MGH), samples will be tested using a multiplex polymerase chain reaction (PCR) technology called anchored multiplex PCR (AMP) for single nucleotide variant (SNV) and insertion/deletion (indel) detection in genomic DNA using next generation sequencing (NGS); briefly, genomic DNA was isolated from a formalin-fixed paraffin embedded tumor specimen is sheared with the Covaris M220 instrument, followed by end-repair, adenylation, and ligation with an adapter; a sequencing library targeting hotspots and exons in 39 genes (including BRAF, exons 11 and 15) is generated using two hemi-nested PCR reactions; Illumina MiSeq 2 x 147 base paired-end sequencing results are aligned to the hg19 human genome reference using BWA-MEM; MuTect and a laboratory-developed insertion/deletion analysis algorithm are used for SNV and indel variant detection, respectively; this assay has been validated to detect SNV and indel variants at 5% allelic frequency or higher in target regions with sufficient read coverage; this test was developed, and its performance characteristics were determined by the MGH Center for integrated diagnostics
All Arms:
For patients who have undergone mastectomy, any type of mastectomy and any type of reconstruction (including no reconstruction) are allowed; metallic components of some tissue expanders may complicate delivery of proton therapy; any concerns should be discussed with the Breast Committee Study Chairs prior to registration
Any anticoagulation drug/strategy may be used to treat the index VTE; protocol treatment will begin <= 30days after the index VTE diagnosis date
FOR PATIENTS ENROLLED IN THE EXPANSION COHORT: willingness to undergo mandatory biopsies (day -14, approximately 4 hours post end of irinotecan infusion and day 1, approximately 4 hours post end of irinotecan infusion [= 3 hours post end of VX-970]); patients enrolled to this cohort should have tumors deemed easily accessible for biopsies with low likelihood of complication
Uncorrected hyponatremia (defined as serum sodium value of <130 mEq/L)
estrogen-gestagen based contraceptives associated with inhibition of ovulation (oral, intravaginal, transdermal),
gestagen-only based contraceptives associated with inhibition of ovulation (oral, injectable, implantable),
intra-uterine devices (IUDs),
sexual abstinence in accordance with an individual's lifestyle
Serologic documentation of HIV infection at any time prior to study entry, as evidenced by positive enzyme-linked immunosorbent assay (ELISA), positive western blot, or any other federally approved licensed HIV test; alternatively, this documentation may include a record that another physician has documented that the participant has HIV infection based on prior ELISA and western blot, or other approved diagnostic tests
Participant must accept to be treated with only one of the following BAT options on Cycle 1 Day 1 (additions and changes are allowed during the course of the study, but only with BAT from the following BAT options): extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, ibrutinib
The study is open to all participants regardless of gender or ethnicity; efforts will be made to extend the accrual to a representative population; if differences in outcome that correlate to gender, racial, or ethnic identity are noted, accrual may be expanded or additional studies may be performed to investigate those differences more fully
Radioactive iodine (RAI)-refractory disease defined as 1 or more of the following:\r\n* Patients who have received greater than 600 mCi of radioactive iodine in their lifetime OR\r\n* RAI-avid metastatic lesion which remained stable in size or progressed despite RAI treatment within 9 months of RAI treatment OR\r\n* 10% or more increase in serum thyroglobulin (on thyroid-stimulating hormone [TSH]-suppression) within 9 months of RAI treatment OR\r\n* Index metastatic lesion non-RAI avid on a diagnostic RAI scan OR\r\n* Presence of fluorodeoxyglucose (FDG) avid metastatic lesions on positron emission tomography (PET)/CT scan (standardized uptake values [SUV]max > 5 of any single lesion)
All patients with known diagnosis of neurofibromatosis type 1 or other known retrovirus-associated deoxyribonucleic acid (DNA) sequence (RAS)-opathies are excluded
Patients requiring biliary stent placement must have biliary stent placed > 7 days prior to screening.
Patients with suspected non-gynecologic malignancy, such as gastrointestinal
Biliary Adenocarcinoma (gallbladder or biliary tree (intrahepatic or extrahepatic cholangiocarcinoma) except Ampulla of Vater cancers)
OR
Requires urinary catheterization for voiding due to obstruction secondary to prostatic enlargement well documented to be due to prostate cancer or benign prostatic hyperplasia (BPH)
Patients allergic to sesame seed oil or cottonseed oil are excluded
Cohort B: Patients with histologically confirmed locally advanced or metastatic clear cell renal cell caricnoma (with clear cell component on pathology), who have been treated with at least one prior systemic therapy for locally advanced or metastatic disease, including either tyrosine kinase inhibitor and/or immune checkpoint inhibitor, with evidence of SETD2 mutation on CLIA-certified next generation sequencing panel\r\n* All next generation sequencing (NGS) sequencing reports including information pertaining to mutant allele frequency and chromosome 3p loss will be reviewed by the University of California at San Francisco (UCSF) Molecular Tumor Board to verify bi-allelic loss of SETD2
PMF, PPV-MF, or PET-MF (as defined by Tefferi and Vardiman 2008)
Treatment for ?3 months with inadequate efficacy response defined as <10% spleen volume reduction by MRI or <30% decrease from baseline in spleen length by physical examination or regrowth to these parameters following an initial response; and/or
Treatment for ?28 days complicated by either i. Development of a red blood cell transfusion requirement (at least 2 units/month for 2 months) ii. National Cancer Institute (NCI) CTCAE grade ?3 AEs of thrombocytopenia, anemia, hematoma, and/or hemorrhage while being treated with a dosage of <20 mg BID
For enrollment into the China extension cohort, residence in the People's Republic of China Disease-specific Inclusion Criteria:
A valid PTEN IHC result (testingcentral laboratory tested with results directly sent to IxRS) (e.g., participants with an \invalid\ or \failed\ PTEN IHC result are not permitted to enroll)
Consistent and correct usage of established hormonal contraceptives that inhibit ovulation
Consistent and correct usage of established hormonal contraceptives that inhibit ovulation
Required used of folate-containing supplements (e.g. folate deficiency)
Male patients, even if surgically sterilized (i.e., status post-vasectomy), who:
Admitted to an institution by administrative or court order
Current use of metformin, or strong antioxidants (extracts from grape seed, milk thistle; pine bark, green tea, saw palmetto; resveratrol; flavonoids; catechins; ellagic acid), large quantities of red grapes, white button mushrooms, red wine
HSIL cytology with no invasive features identified on colposcopy or the baseline biopsy
No risk factors for microinvasive disease (no colposcopic features of microinvasion, adequate colposcopy and negative endocervical curettage)
FAZ053 single agent: NSCLC/ TNBC/ Endometrial cancer / Anaplastic thyroid cancer/Selected indication(s) in dose expansion group every 6 Weeks (Q6W) dosing regimen
FAZ053 in combination with PDR001: NSCLC/TNBC / Selected indication(s) in dose expansion group Q6W dosing regimen
Presence of gliomatosis cerebri, cranial or spinal leptomeningeal metastatic disease
Participants enrolling into the NTRK cohort must have an NTRK1, 2, or 3 rearrangement as confirmed by targeted NextGen sequencing using the DFCI/BWH OncoPanel or another CLIA-certified method
Participants enrolling to the NTRK cohort who have received a prior NTRK inhibitor may not be on anticoagulant therapy unless the investigator has deemed it safe to temporarily hold to facilitate the baseline tumor biopsy
Participant has taken any of the following medications within the past 3 months:\r\n* A thiazolidinedione (e.g. pioglitazone [Actos] or rosiglitazone [Avandia]),\r\n* A biguanide (e.g. metformin [Glucophage, Glumetza, Fortamet, Riomet] or proguanil [Paludrine])\r\n* A combination drug containing one of the agents above (brand names include: ACTOplus Met, Avandamet, Avandaryl, Duetact, Glucovance, Invokamet, Janumet, Jentadueto, Komboglyze, Metaglip, PrandiMet, Synjardy, Xigudo)
Participant is currently taking a cationic drug or multidrug and toxin extrusion [MATE] inhibitor (e.g. amiloride [Midamor]; cimetidine [Tagamet]; digoxin [Lanoxin, Digitek, Digox]; dolutegravir [Tivicay]; morphine [Roxanol, Duramorph, Kadian, MS Contin]; procainamide [Pronestyl, Procanbid]; quinidine [Quinidex, Cardioquin, Quin-G, Quinora]; quinine [Qualaquin, Quinamm, Quiphile]; ranitidine [Zantac, Deprizine, Gabitidine]; ranolazine [Ranexa]; triamterene [Dyrenium)] trimethoprim [Proloprim, Trimpex, Primsol]; vancomycin [Vancocin, Vancoled]; or vandetanib [Calpresa])
Participant has > Common Terminology Criteria for Adverse Events (CTCAE) grade 1 limb edema (5 - 10% inter-limb discrepancy in volume or circumference at point of greatest visible difference; swelling or obscuration of anatomic architecture on close inspection)
TREATMENT INCLUSION: Age 16 to 75 for the first three patients on a dose level; thereafter, if no dose limiting toxicity (DLT), patients aged 12 to 75 can be treated on that dose level
Coexisting ophthalmic disease likely to require slit-lamp examination within the next 90 days
Pregnant or intend to become pregnant, breastfeeding or intend to breastfeed during the study
Anthracyclines within 90 days before first ZW25 dosing or lifetime load exceeding 300 mg/m² adriamycin or equivalent
Has had an interruption of tazemetostat dosing of >14 days from the antecedent clinical study to starting the rollover study.
Presence of a hip prosthesis
Unresectable HCC, defined by imaging criteria or cytohistologic assessment; TACE as a preferred method of treatment is determined by a multidisciplinary Brigham and Women’s Hospital (BWH)/Dana Farber Cancer Institute (DFCI) Liver Tumor Board
Patients with known sensitivity to conductive hydrogels like the gel used on electrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes
FOLFIRINOX
Known underlying collagen vascular disease or intrinsic lung disease that could complicate expected sequelae of radiation (idiopathic pulmonary fibrosis, Wegener’s granulomatosis)
Have persistent active cGVHD manifestations, as defined by 2014 NIH Consensus Development Project on Criteria for Clinical trials in cGVHD, after at least 2 months of steroid therapy.
Must meet criteria for high risk disease\r\n* Patients with International Neuroblastoma Staging System (INSS) stage 4 disease are eligible with the following\r\n** MYCN amplification (greater than four-fold increase in MYCN signals as compared to reference signals), regardless of age or additional biologic features\r\n** Age >18 months (> 547 days) regardless of biologic features\r\n** Age 12-18 months (365-547 days) with any of the following unfavorable biologic features (unfavorable pathology and/or deoxyribonucleic acid [DNA] index =1) or any biologic feature that is indeterminate/unsatisfactory/unknown
PMBCL
Gr3b-FL
TH-FL
Known intolerance to immunomodulatory drugs (IMiDs)
Bulky disease
Extrahepatic metastases
Allow biopsies
MET exon 14 skipping alteration or MET amplification (MET:CEP7 ratio >= 1.8) by molecular testing (local testing is accepted for eligibility; all patients will have confirmation at Massachusetts General Hospital [MGH] but this result is not necessary for eligibility; local molecular pathology result will suffice); this testing can be from any archival or fresh sample
Patients must have disease that is suitable for repeated measurement, either
Absolute neutrophil count ? 1.5 x 10?/Liters (L) (1500/cubic millimeters)
Be receiving concurrent antiviral agent active against vaccinia virus (e.g., cidofovir, vaccinia immunoglobulin, imatinib, ST-246) during the course of study
Documented MAPK pathway alteration
Positive cytology
The presence of extra capsular, seminal vesicle invasion or metastatic disease.
Altered mental status preventing consent or answering questions during conduct of the trial will be excluded for safety purposes.
Active pulmonary disease requiring medication to include multiple inhalers (>2 inhalers and one containing steroids)
prior IMiD exposure
Age >= 4 years old and toilet-trained; participants must be able to deposit stool samples directly into stool collection containers
Appropriate staging imaging.
The following baseline neurocognitive assessments must be completed and uploaded within 10 calendar days after or at the time of Step 1 registration: HVLT-R (recall, delayed recall, and recognition), TMT (parts A and B), and COWA; the neurocognitive assessments will be uploaded into the National Surgical Adjuvant Breast and Bowel Project, Radiation Therapy Oncology Group, and Gynecologic Oncology Group (NRG) Oncology RAVE system for evaluation by Dr. Wefel; once the upload is complete, within 3 business days, a notification will be sent to the site to proceed to Step 2 registration; at minimum, the HVLT-R delayed recall must be able to be scored (i.e. completed without error) in order to be eligible
Patients must have a baseline raw score greater than 2 on the HVLT-R delayed recall. as determined by central assessment by the Neurocognitive Co-Chair, Dr. Wefel
Radiographic evidence of hydrocephalus or other architectural distortion of the ventricular system, including placement of external ventricular drain or ventriculoperitoneal shunt
Prior exposure to ixazomib; however, prior bortezomib exposure is allowed
Myopathy or any clinical situation that causes significant and persistent elevation of CPK (> 2.5 × ULN in two different determinations performed one week apart).
Documented MAPK alteration
Prior treatment with a BRAFi, MEKi and/or pan-RAF inihibitors for patients to be enrolled in group 1 and 2 in the dose expansion part. Exceptions may be made after documented agreement between Novartis and Investigator.
Consensus among the PI, key assistant investigators (AIs), and consultants (as necessary) that correction of the patient’s immune system through BMT has the potential to improve the patient’s health, quality of life, and/or life expectancy, after taking into consideration the patient’s existing non-hematopoietic, potentially irreversible organ dysfunction
Presence of gliomatosis cerebri, cranial or spinal leptomeningeal metastatic disease
EXPANSION COHORT: There should be a 2- to 4-week break between the patient’s last dose of standard chemotherapy to initiation of the first cycle of study drugs; longer than 4-week break may be permitted at the discretion of the principal investigator (PI)
Two oncologists disagree on prognosis or resectability
Patients with LCH must require systemic therapy according to the Histiocyte Society LCH Evaluation and Treatment Guidelines OR patients with HS requiring systemic treatment as defined by disease that cannot be surgically resected and/or encompassed in a single radiation field
18+ yrs (US), 21+ yrs (Singapore)
Normal urinalysis
Symptomatic vertebral fragility fractures or fragility fracture of hip, pelvis, wrist, or other location (fragility fracture - any fracture w/out trauma or as a result of a fall from ?standing height)
Moderate (25%-40% decrease vertebral ht.) or severe (>40% decrease vertebral ht.) morphometric vertebral fractures
?-CTX serum level >1000 pg/mL (morning after ?10hrs fasting)
Thiazolidinedione peroxisome proliferator-activated receptor gamma agonist (e.g. Actos® [pioglitazone] and Avandia® [rosiglitazone]) w/in 4 wks prior to study drug
PO or IV glucocorticoid for ?4 wks at daily dose eq. to ?7.5 mg of PO prednisone w/in 12 wks prior to study drug dosing
Hyperparathyroidism, Paget's disease or osteomalacia
Gastric bypass
Low- or high-grade non-nodular, previously untreated (\treatment naïve\) dysplastic BE, confirmed by histopathological analysis. If nodular BE or Intramuscosal Cancer (ImCA) is identified during patient screening, this may be treated with Endoscopic Mucosal Resection (EMR) ?6 weeks prior to treatment under this protocol. If previous EMR was performed, follow-up endoscopy must be negative for nodular BE. Patients with ImCA must be at low risk for recurrence, confirmed by EMR pathology results negative for positive margin, poorly differentiated carcinoma, and lymphovascular invasion.
Operable per institution's standards
Esophageal stenosis/stricture preventing advancement of a therapeutic endoscope (patients may have the stenosis/stricture dilated and then be treated with CryoBalloon ablation under this protocol at a subsequent procedure ?2 weeks later)
Any endoscopically-visualized abnormalities such as ulcers, masses or nodules. Neoplastic nodules must first be treated with EMR ?6 weeks prior to planned treatment under this protocol.
Prior distal esophagectomy
Any clinical or histological suspicion of esophageal adenocarcinoma invading into the submucosa by endoscopic mucosal resection (EMR), or confirmed T1a cancer with positive deep margin by EMR
Patients must have histologically confirmed adenocarcinoma of the prostate without previous therapy for PC\r\n* Treatment-naive AND\r\n* Undergoing RP as initial, locally definitive therapy for PC AND\r\n* Eligible for RP in a 3 month timeframe AND\r\n* Consentable for RP
Subject has prior use of any anti-cancer treatment or product, such as PC-SPES (or any other PC-x product: PC-HOPE, PC-CARE, PC-PLUS, etc)
Aggressive clinical behavior requiring previous treatment with chemotherapy even if histologic features such as the Ki67 index or mitotic rate corresponds with low or intermediate grade.
Congestive cardiac failure of >Grade 2 severity according to the NYHA defined as symptomatic at less than ordinary levels of activity
Prior exposure to Astellas ASP2215.
myelodysplasia
Patients with phaeochromocytoma
Uncontrolled fecal incontinence
Active cases (within the past 12 months) of depressive disorder, manic episodes, and/or anxiety requiring active treatment with a selective serotonin reuptake inhibitor (SSRI); patients being treated with an SSRI for non-psychiatric indications (such as hot flashes) are allowed and should go through the appropriate washout
Part 2:
Patients must have at least one measurable PN, defined as a lesion of at least 3 cm measured in one dimension; patients who underwent surgery for resection of a PN are eligible provided the PN was incompletely resected and is measurable as per criteria above; measurability and suitability for volumetric MRI analysis of the target PN must be confirmed with the National Cancer Institute (NCI) Pediatric Oncology Branch (POB) prior to enrolling a patient; the target PN will be defined as the clinically most relevant PN, which has to be amenable to volumetric MRI analysis; PN will be classified as “typical PN” or “nodular PN” versus \solitary nodular PN\ prior to enrollment
Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (patients who are wheelchair bound because of paralysis secondary to a plexiform neurofibroma should be considered ambulatory when they are up in their wheelchair; similarly, patients with limited mobility secondary to need for mechanical support (such as an airway PN requiring tracheostomy or continuous positive airway pressure [CPAP] will also be considered ambulatory for the purpose of the study)
Willingness to avoid excessive sun exposure and use adequate sunscreen protection if sun exposure is anticipated
Monocular vision or has media opacities or any other condition that precludes monitoring of the retina or the fundus, or has a history of ophthalmology exam with retina or cornea abnormalities
diagnosis of HGG, DIPG, low grade astrocytoma, medulloblastoma/PNET, ependymoma, neuroblastoma, RMS and tumours with ErbB deregulation
Ongoing treatment with chronic, therapeutic dosing of anti-coagulants.
Willingness to provide all biologic specimens as required by the protocol
Resistant to all of the following: DOXIL, gemcitabine hydrochloride (GEM), topotecan hydrochloride (TOPA), and weekly paclitaxel (TAXOL); (NOTE: resistance is defined as either 1) less than a complete response to any chemotherapy regimen containing the agent in question [consider weekly TAXOL as a separate agent from every-three-week TAXOL], 2) serum CA-125 >= 2 x ULN within 180 days of last dose of chemotherapy containing the agent in question, confirmed by a second CA-125 [the second CA-125 does not have to be within 180 days of chemotherapy], or 3) CT or PET/CT evidence of cancer recurrence/progression within 180 days of last dose of chemotherapy containing the agent in question; [for example, if a patient previously received carboplatin and GEM, had a complete response, and had initial evidence of relapse > 180 days after the last dose of GEM, that patient would not be considered resistant to GEM])
Exposure to household contacts =< 15 months old or household contact with known immunodeficiency
ibritumomab tiuxetan (biologic half-life in NHL = 1.9 days [based upon measurement of radioactivity from administered [111In]-ibritumomab tiuxetan]; required washout = 10 days (1.5 weeks)
Subject in whom the bleeding flux from the identified lesion is > 0.000040[g/(cm²•s)] and ?0.013[g/(cm²•s)].
Subject undergoing a cardiac procedure in which there is no aortic anastomosis or aortotomy suture line to evaluate using the bleeding severity scale (i.e., not for treatment at the distal coronary artery bypass graft anastomosis);
Patients must be off all colony-forming growth factor(s) for at least 1 week prior to registration (e.g. filgrastim, sargramostim, erythropoietin); 2 weeks must have elapsed for long-acting formulations
Patients who are immunocompetent
Patients with cytologic evidence of glandular dysplasia
Completed 6 to 12 months (± 2 weeks) of initial therapy, during which the participant was treated to best response, defined as the best response maintained for 2 cycles after the M-protein nadir is reached.
Complete documentation of the details of the initial therapy before randomization including cytogenetics and International Staging System (ISS) is available.
Recent (within 8 weeks) history of central nervous system (CNS) hemorrhage unless the hemorrhage is located within the tumor that will be removed en total during surgical debulking or ablated during MLA
Patients with sinonasal SCCAs
ELIGIBILITY FOR SCREENING: Any patient with diagnosis of either:\r\n* EBV positive Hodgkin’s lymphoma\r\n* EBV positive non-Hodgkin’s lymphoma (regardless of histologic subtype)\r\n* EBV (associated)-T/NK-lymphoproliferative disease\r\n* Severe chronic active EBV (CAEBV)** AND\r\n* In first or subsequent relapse (Group A)\r\n* With active disease persisting despite therapy (Group B)\r\n* With active disease if immunosuppressive chemotherapy is contraindicated e.g. patients who develop Hodgkin disease after solid organ transplantation or if the lymphoma is a second malignancy e.g. a Richter's transformation of chronic lymphocytic leukemia (CLL) (Group C)\r\n** CAEBV is defined as patients with high EBV viral load in plasma or peripheral blood mononuclear cell (PBMC) (> 4000 genomes per ug PBMC deoxyribonucleic acid [DNA]) and/or biopsy tissue positive for EBV
ELIGIBILITY CRITERIA AT TIME OF TREATMENT: Any patient with diagnosis# of either:\r\n* EBV positive Hodgkin’s lymphoma\r\n* EBV positive non-Hodgkin’s lymphoma (regardless of histologic subtype)\r\n* EBV (associated)-T/NK-lymphoproliferative disease\r\n* Severe chronic active EBV (CAEBV)** AND#\r\n* In first or subsequent relapse (Group A)\r\n* With active disease persist despite therapy (Group B)\r\n* With active disease if immunosuppressive chemotherapy is contraindicated e.g. patients who develop Hodgkin disease after solid organ transplantation or if the lymphoma is a second malignancy e.g. a Richter's transformation of CLL (Group C)\r\n** CAEBV is defined as patients with high EBV viral load in plasma or PBMC (> 4000 genomes per ug PBMC DNA) and/or biopsy tissue positive for EBV\r\n# The disease diagnosis and the group must be noted on the eligibility checklist
Patients with a history of a metabolic disorder including documented defect in urea metabolism (including documented history of gout), carnitine deficiency (primary carnitine deficiency, carnitine palmitoyltransferase I or II deficiency, carnitine translocase deficiency), fatty acid metabolism, beta-oxidation defects, pyruvate carboxylase deficiency, mitochondrial function, porphyria, or treatment refractory nephrolithiasis
Principal Inclusion criteria:\n\n          -  Aged at least 18\n\n          -  The presence of a solid malignant tumour that is not considered appropriate for\n             further standard treatment\n\n          -  Module 1 and 2 Part B study expansions, and Module 3: patients must have a tumour at\n             least 1 cm in size that can be measured using a CT or MRI scan\n\n          -  Module 1 Part B Study expansion: second line lung adenocarcinoma with ATM deficient\n             tumours.\n\n          -  Module 2 Part B All - No previous treatment with PARP inhibitor.\n\n          -  Module 2 Part B1 Study expansion: advanced gastric adenocarcinoma (including GEJ)\n             patients with ATM deficient tumours\n\n          -  Module 2 Part B2 Study expansion: advanced gastric adenocarcinoma (including GEJ)\n             patients with ATM proficient tumours\n\n          -  Module2 Part B3 Study expansion: Second or thrid line HER2 negative breast cancer\n\n          -  Module 2 Part B4 Study expansion: Second or third line triple negative breast cancer\n             (TNBC) Module 3: advanced recurrent or metastatic non-small cell lung cancer, or head\n             and neck squamous cell carcinoma\n\n        Principal exclusion criteria\n\n          -  A diagnosis of ataxia telangiectasia\n\n          -  Prior exposure to an ATR inhibitor\n\n          -  Bad reaction to AZD6738\n\n          -  Module 1: Contra-indicated for treatment with carboplatin\n\n          -  Module 2: Contra-indicated for treatment with olaparib\n\n          -  Module 3: Contra-indicated for treatment with MEDI4736
Patients with cataracts on ophthalmologic examination
Known uncompensated hypothyroidism (defined as greater than 2x upper limit of normal not treated with replacement hormone)
Patients with uncontrolled infections for whom myeloablative HCT is considered contraindicated by the consulting infectious disease physician (upper respiratory tract viral infection does not constitute an uncontrolled infection in this context)
Patients must have histological verification of the diagnosis of Langerhans cell histiocytosis according to the criteria described in Section 6.1
AD worse in risk organs after week 6 (after Initial Course 1), or AD worse or AD intermediate in risk organs after week 12 (after Initial Course 2).
PLT <20 x109/L (20,000/?L) and/or transfusion dependency (both criteria have to be fulfilled) AND/OR
Total protein <55 g/L or substitution dependency
Albumin <25 g/L or substitution dependency (at least one of the two criteria to be fulfilled)
AD worse in risk organs after week 6 (after Initial Course 1), or AD worse or AD intermediate in risk organs after week 12 (after Initial Course 2) of Stratum I OR
AD worse after the 2nd and 3rd 2-CdA/Ara-C course, and those AD worse or AD intermediate after the 4th 2-CdA/Ara-C course of Stratum III AND
LCH-related permanent consequences (e.g. vertebra plana, sclerosing cholangitis, lung fibrosis, etc.) in the absence of active disease
Permanent consequences (e.g. sclerosing cholangitis, lung fibrosis, etc.) without evidence of active LCH in the same organ or in any other locations
Isolated sclerosing cholangitis without evidence of active hepatic LCH as the only evidence of risk organ involvement.
Patients must be at least 1 week from the last dose of complementary or alternative medications
Subjects being treated with a monoamine oxidase inhibitor (MAOI), or drug which has significant MAOI activity (e.g., meperidine, linezolid, methylene blue) within 3 weeks prior to screening
Elevated Troponin 1 levels at screening or known to have persistently elevated brain natriuretic peptide (BNP).
Presence of aneurisms of the ascending aorta or aortic stress.
Drugs which are exclusively or primarily eliminated by cytochrome P-450 isozyme 3A4 (CYP)3A4.
Drugs which are exclusively or primarily eliminated by UDP glucuronyltransferase 1A1 (UGT)1A1.
Patients must have disease limited to the hemithorax
Patients must have measurable contrast-enhancing supratentorial tumor (>= 0.2 cc [current resolution of MRSI is 0.108 cc]) in a region amenable to MRSI
Patients with any disease that will obscure toxicity or dangerously alter drug metabolism are excluded
Patients taking any of the following category I drugs that are generally accepted to have a risk of causing Torsades de Pointes =< 7 days prior to registration (for cohort 2a and 2b [belinostat cohort] only)\r\n* Quinidine, procainamide, disopyramide\r\n* Amiodarone, sotalol, ibutilide, dofetilide\r\n* Erythromycin, clarithromycin\r\n* Chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide\r\n* Cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine
Meets clinical diagnostic criteria for NF2 or genetically conformed NF2
MRI evidence of progression (either as > 2 mm increase in maximum linear diameter on conventional MRI, or a > 20% volume increase by 3-dimensional [3D] volumetrics) over the past =< 18 months OR progressive hearing loss, defined as a decline in word recognition score below the 95% critical difference interval from baseline score related to VS (i.e., not due to prior interventions such as surgery or radiation)
Patients with oropharyngeal squamous cell carcinoma may have p16(+) or p16(-) disease; in these patients, p16 status must be known prior to randomization; assessment of p16 status may occur locally or centrally; note: the definition of p16(+) disease is diffuse nuclear and cytoplasmic staining in >= 70% of tumor cells
Medical contraindications to stopping aspirin, Coumadin or other anticoagulants prior to image-guided tumor biopsies; follow institutional guidelines when determining drugs to avoid and length of washout
Patients should be asymptomatic for jaundice prior to Day 1.
International Prognostic Index must be documented:\r\n* ECOG performance status >= 2 (1 point)\r\n* Age >= 60 (1 point)\r\n* >= 2 extranodal sites (1 point)\r\n* Lactate dehydrogenase (LDH) > upper limit of normal (1 point)\r\n* Ann Arbor stage III or IV (1 point)
Patients who are reported to be of direct Asian-Pacific (China, Japan, Taiwan, Singapore, Republic of Korea, and Thailand) ancestry
Tumor must be deemed to be inoperable or unresectable either by clinical or radiographic criteria; these criteria include encasement of great vessels, vertebral invasion or undue peri-operative risk
Have Q-T intervals greater than 550 ms unless treated with an Accysync model 72 synchronization system controlling the NanoKnife system’s output pulses
Have taken any chemotherapeutic agent within 5 weeks of treatment with the NanoKnife irreversible electroporation (IRE) system
RETREATMENT WITH MODIFIED T-CELLS INCLUSION CRITERIA: Subject has tolerated prior dose of modified \r\nT cell infusion without experiencing a dose limiting toxicity OR if patient did have a dose limiting toxicity (DLT), they have fully recovered back to baseline
Patients must have received prior temozolomide or an alkylating agent (ex. lomustine [CCNU]/carmustine [BCNU])
Patients must have had histologic verification of an extracranial germ cell tumor that is not a pure teratoma (mature or immature), pure germinoma, or pure seminoma
INCLUSION - TREATMENT: Available autologous transduced cytotoxic T lymphocytes with ? 20% expression of GD2 CAR and killing of GD2-positive targets ? 20% in cytotoxicity assay
An ECG recorded at screening showing evidence of cardiac ischemia (ST depression of >= 2 mm, measured from isoelectric line to the ST segment); if in any doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not CAD is present
Patients with up to two prior recurrences are allowed
COHORT B ONLY: Obtained =< 14 days prior to registration: N-terminal pro b-type natriuretic peptide (NT-ProBNP) < 7500 ng/dL
Subjects must either have a CA 19-9 value > the institutional upper limit of normal (ULN) on two separate checks at least 2 weeks apart OR have had an R1 resection margin OR N1 nodal disease regardless of CA 19-9 level
Patients that have been prescribed sipuleucel-T and have not started treatment
V-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) or neuroblastoma (N) RAS mutant tumors
Lithium medication
Breast size exceeding the technical limitation of daily set-up reproducibility. This may be center-specific and will be assessed at the discretion of the treating center.
Symptomatic neurologic disease compromising instrumental activities of daily living or requiring medication
Patients with pathologically confirmed smoldering or chronic adult T- cell leukemia as defined by Shimoyama
Leukemia participants aged 1 to 5 years with induction failure and favorable cytogenetics (i.e., ETV6-RUNX1 or hyperdiploidy defined as deoxyribonucleic acid [DNA] index >= 1.16 or modal chromosome number >= 51)
COHORT B, GROUP 7: GALLBLADDER CANCER OR CHOLANGIOCARCINOMA: If the patient has had decompression of the biliary tree within the last 14 days, stability of the bilirubin level needs to be confirmed with two measurements that are within 5 to 7 days of each other; (the second measurement must be obtained within 7 days prior to registration); both the first and second measurement must be < 1.5 x institutional ULN (IULN); stability is defined as the second measurement being no more than one point higher than the first
Special classes of subjects such as fetuses, pregnant women, children, prisoners, institutionalized individuals, or others who are likely to be vulnerable
Metastatic or unresectable measurable cancers that express mesothelin; as in other protocols conducted by Dr. Hassan in the National Cancer Institute (NCI), epithelial mesotheliomas and pancreatic cancers do not need to be assessed for mesothelin expression since all of these tumors have been shown to express mesothelin; other metastatic or unresectable cancers must be shown to expresses mesothelin as assessed by reverse transcriptase-polymerase chain reaction (RT-PCR) or immunohistochemistry on tumor tissue; bi-phasic mesotheliomas must express mesothelin on greater than 50% of the cells in the epithelial component; diagnosis will be confirmed by the Laboratory of Pathology, NCI
Patients with diabetic retinopathy
An artificial implant that cannot be easily removed (e.g., heart valves, prosthetic hips or knees, or other devices), which could allow a nidus of infection.
Patients with indwelling catheters (other than Portacath, Hickman or PICC lines)
5-FC
5-FU
Granulocytes ? 1,500/ml
Willing and able to fill out a pill diary to ensure compliance
Evidence of uncontrolled extrathoracic metastases
Must be willing to have an Ommaya reservoir placed and a candidate for an Ommaya reservoir placement
Cannot be on systemic agents (chemotherapy) that have central nervous system (CNS) penetration (temozolomide, carmustine [BCNU], lomustine [CCNU], etoposide, Xeloda, carboplatin, Navelbine, bevacizumab, CPT-11 and topotecan; note: please check with study principal investigator [PI] [Dr. Raizer] to clarify other agents not listed) unless they develop or have progressive or persistent leptomeningeal metastases while on these agent(s) and have controlled systemic disease\r\n* NOTE: may continue on intravenous (IV) trastuzumab, pertuzumab, TDM-1, lapatinib or hormonal agents if controlling systemic disease and developed LM while on therapy \r\n* NOTE: patients requiring systemic agents (such as those listed above) are eligible but will not be able to start treatment until after the first assessment by imaging and cytology
Neurotropism is identified pathologically by the presence of melanoma cells around nerve sheaths (perineural invasion) or within nerves (intraneural invasion).
Occasionally, the tumour itself may form neuroid structures (termed 'neural transformation'; this is also regarded as neurotropism)
\normal\-looking nerves that appear to be \entrapped\ within the tumour should not be regarded as neurotropism
Clinical and/or MRI evidence of a named cranial or cervical nerve involvement by tumour
Albinism
Patients who are in the estimation of the principal investigator (PI), deemed unable or unlikely to adhere to protocol treatment
Symptomatic splenomegaly
At the investigator’s discretion, receipt of a live vaccine within 4 weeks prior to randomization; efficacy and/or safety of immunization during periods of B-cell depletion have not been adequately studied; it is recommended that a patient’s vaccination record and possible requirements be reviewed; per the investigator’s discretion, the patient may have any required vaccination/booster administered at least 4 weeks prior to the initiation of study treatment; review of the patient’s immunization status for the following vaccinations is recommended: tetanus; diphtheria; influenza; pneumococcal polysaccharide; varicella; measles, mumps and rubella (MMR); and hepatitis B; patients who are considered to be at high risk for hepatitis B virus (HBV) infection and for whom the investigator has determined that immunization is indicated should complete the entire HBV vaccine series at least 4 weeks prior to participation in the study
Patients with an active infectious disease requiring deferral of conditioning; as recommended by an infectious disease specialist
DONOR: Unrelated Umbilical Cord Blood: The UCB unit with the least HLA disparity (with the patient) will be selected first (i.e., selection priority is 6/6 match > 5/6 match> 4/6 match); additional UCB units then may be selected to achieve the required cell dose; if a second unit is required, this unit will be the unit that most closely HLA matches the patient and meets minimum size criteria outlined below of at least 1.5 x 10^7 TNC/kg (ie a smaller more closely matched unit will be selected over a larger less well matched unit as long as minimum criteria are met)
Patients must be treated with a standard accepted chemotherapy regimen for rhabdomyosarcoma (for example, according to Intergroup Rhabdomyosarcoma Study [IRS]-IV, IRS-V, or future IRS study)
Non-healing wounds on any part of the body.
Eribulin dose modification necessary in patients with hepatic insufficiency according to United Surgical Partners International (USPI).
Patients with MRI or clinical evidence of uncontrolled tumor mass effect are excluded; the assessment of mass effect should be made by the study chairs and study neurosurgeons prior to any planned CED treatment.
Required used of folate-containing supplements (e.g. folate deficiency)
Blood sample submitted for additional testing within 7 days of TIL harvest per national blood banking standards (e.g., anti-human T-cell lymphotropic [HTLV]-I/II virus, anti-T. cruzi, West Nile virus nucleic acid testing [NAT], anti-cytomegalovirus [CMV], rapid plasma reagin [RPR]), for purposes of proper handling and storage.
BM with increased fibrosis (reticulin stain > 1/3).
Patients with Charcot-Marie-Tooth disease or other demyelinating diseases are excluded from the liposomal vincristine containing arm
Urothelial cancer (UC) in the upper genitourinary tract (kidneys, renal collecting systems, ureters) within 24 months of enrollment
Adequate peripheral nervous system (PNS) function defined as:\r\n* PNS toxicity < grade 2
Patients who are pregnant or breast-feeding. The anti-proliferative activity of this experimental drug and temozolomide may be harmful to the developing fetus or nursing infant
Subject has 1 first-degree relative (FDR; defined as parents, offspring or siblings) with T1D AND A1C value > 6.5% or
Hepatitis B or C seropositivity with evidence of ongoing liver damage, which would increase the likelihood of hepatic toxicities from the chemotherapy conditioning regimen and supportive treatments; if there is a positive result in the infectious disease testing that was not previously known, the patient will be referred to their primary physician and/or infectious disease specialist
> 1 hospital admission for infection in prior 6 months
Platelet count < 50,000/mm^3, per PI discretion if thought to be related to underlying myeloma
Parkinson’s disease
Inoperable on the basis of co-existent medical problems
Patients who are on one systemic immunosuppressive agent for chronic GVHD with a plan to withdraw all systemic IST; hydrocortisone continued for treatment of adrenal insufficiency is not considered a systemic IST
Agreement to be contacted by phone or e-mail for health status evaluation for up to 3 years
No evidence of an active malignancy that would limit the patient’s survival to less than 2 years. (If there is any question, the principal investigator [PI] can make a decision).
A skull defect (such as, missing bone with no replacement)
Known hypersensitivity to conductive hydrogels like the gel used on electrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes
Patients with non-healing surgical incisions or wounds on the scalp
Presence of any other medical complication that implies survival of less than six months
Significant arteriovenous shunt identified on angiography of the hepatic artery
Patients must not be receiving any chemotherapy agents (except hydroxyurea); intrathecal methotrexate and intrathecal cytarabine are permissible
Expired breath carbon monoxide < 10
Positive urine toxicology-5 screen (methamphetamine, cocaine, opiates, benzodiazepines, tetrahydrocannabinol [THC])
IDH1-R132 mutated disease status as assessed by local laboratory. 2HG-producing IDH1 variants outside of R132 (i.e. R100) may be eligible after discussion with the principal investigator (PI).
Actively receiving insulin or requiring fingerstick glucose monitoring at time of ascorbate infusion (unless an exception is granted by the investigational new drug [IND] sponsor, medical monitor, and the principal investigator [PI])
Patients who are on the following drugs and cannot have a drug substitution: flecainide, methadone, amphetamines, quinidine, and chlorpropamide. High dose ascorbic acid may affect urine acidification and, as a result, may affect clearance rates of these drugs
Sufficient mental capacity to provide informed consent and answer Short-Form Six-Dimension health index (SF-6D) and Borg score questions
Patients who are known to be both V-kit Hardy-Zuckerman 4 feline sarcoma viral oncogene homolog (KIT) and platelet-derived growth factor receptor alpha (PDGRF?) wild type.
Uncontrolled active infection (i.e., progressive symptoms related to infection despite treatment or persistently positive microbiological cultures despite treatment or any other evidence of severe sepsis).
Non-GCB of origin by standard immunohistochemical classification
Baseline serum B-type natriuretic peptide (BNP) above the age-adjusted upper limit of normal
Inability to take ixazomib or abatacept
Patients experiencing more than 12 watery bowel movements per day associated with volume contraction, dehydration, or hypotension, or showing evidence of enteric infection are excluded
Concurrent treatment with non-permitted drugs including herbal remedies with immunostimulating properties (for example, mistletoe extract) or known to potentially interfere with major organ function (for example, hypericin)
Serum uric acid =< 8 mg/dL (with or without medication control)
Somatic alteration in one of the following DDR genes as determined by genomic sequencing performed in a Clinical Laboratory Improvement Amendments (CLIA) laboratory. Somatic alterations will include nonsense, frameshift, splice-site or missense mutations or homozygous deletions. Subjects with alterations in DDR genes not included in the list below will be considered on a case by case basis after discussion with the Principal Investigator(s). Subjects with germline alterations in DDR genes will be considered on a case by case basis and will be reviewed by the principal investigator(s). At least 6 subjects will have BRCA or ATM alterations.\r\n* Nucleotide excision repair: ERCC2, ERCC3, ERCC4, ERCC5, ERCC6\r\n* Homologous recombination: BRCA1, BRCA2, RAD50, RAD51, RAD51B, RAD51C, RAD52, RAD54L, NBN, MRE11A, RAD51D, CTIP\r\n* DNA Sensor: ATM, ATR, MDC1, ATRX, CHEK1, CHEK2\r\n* Fanconi anemia pathway: PALB2, BRIP1, FANCA, FANCB, FANCC, FANCD2, FANCE, FANCF, FANCG, BLM\r\n* Base excision repair: XRCC2, XRCC3, XRCC4, XRCC5, XRCC6\r\n* Other: MUTYH, RECQL4, POLQ, POLE, WRN
HTN with need for 2 or more anti-hypertensives to control it at baseline (because there isn’t room to\tadd more antihypertensives if axitinib causes increased blood pressure [BP])
Received systemic glucocorticoids within 28 days prior to the first dose of enzalutamide and/or CORT125281, or requirement for chronic or frequently used systemic glucocorticoids for medical conditions (e.g., rheumatoid arthritis, immunosuppression after organ transplantation)
Patients with Gilbert's syndrome will be eligible for the study; the diagnosis of Gilbert's syndrome is suspected in people who have persistent, slightly elevated levels of unconjugated bilirubin without any other apparent cause; a diagnosis of Gilbert's syndrome will be based on the exclusion of other diseases based on the following criteria:\r\n* Unconjugated hyperbilirubinemia noted on several occasions\r\n* No evidence of hemolysis (normal hemoglobin, reticulocyte count, and lactate dehydrogenase [LDH])\r\n* Normal liver function tests\r\n* Absence of other diseases associated with unconjugated hyperbilirubinemia
Patients with prior pneumonectomy
Taken drugs known to interact with Rapamune such as cyclosporine, diltiazem, erythromycin, ketoconazole (and other antifungals), nicardipine (and other calcium channel blockers), rifampin, verapamil within 14 days prior to enrollment
Cohort B2\r\n* Rising PSA after RP with:\r\n** Extrapelvic metastases as documented by choline, fluciclovine F18 (FACBC) or prostate-specific membrane antigen (PSMA) PET which are:\r\n*** Amenable to treatment with a maximum of 3 radiation isocenters*\r\nAnd/Or\r\n*** Retroperitoneal nodes up to the level of the renal hilum with/without pelvic nodal metastasis\r\n** No evidence of local recurrence on MRI scan of the prostate bed\r\n** Prior salvage radiotherapy is permitted\r\n*Multiple lesions within one isocenter may be permitted upon review by the sponsor’s radiation oncologist
Other acute leukemias: leukemias of ambiguous lineage or of other types e.g. blastic plasmacytoid dendritic cell neoplasm with less than 5% blasts. Persistent/relapsed disease with cytogenetic, flow cytometric or molecular aberrations in >= 5% of cells are eligible.
Grade >= 2 blurred vision, conjunctivitis, corneal ulcer, dry eye, or keratitis
Men who intend to father children during the study or within 4 months afterward are excluded
Histologically confirmed myelodysplastic syndrome with positive TET2 mutations (we will test all MDS patients for TET2 mutations using next generation sequencing and only patients with TET2 mutations will be included in our study)
Prior ipsilateral thoracotomy (the likely presence of adhesions will limit ability to perform a precise block guided by thoracoscopy). Note: previous VATS or robotic surgery is permissible.
Willingness to have 2 tumor biopsies; the first before and the second while on therapy (optional for all patients and may become mandatory in order to ensure 15 patients at maximum tolerated dose [MTD] have paired biopsies).
COHORT I ONLY: Patients that are on ruxolitinib may enroll in study as long as they are willing to remain on ruxolitinib during the study and have not lost response to ruxolitinib defined as an increase in > 5 cm in spleen size from nadir. There is no minimum or maximum time requirement for time on ruxolitinib
COHORT I ONLY: Participants must have splenomegaly (defined by ultrasound or computed tomography [CT] scan of the abdomen) or symptoms (demonstrated by the presence of 1 symptom score > 5 or 2 symptom scores > 3) related to myelofibrosis as measured by the myeloproliferative neoplasm symptom assessment form MPN-SAF and platelets > 25/uL and hemoglobin > 7/dL
Asymptomatic adenovirus viremia defined as no symptoms of adenovirus disease and EITHER two positive and quantifiable quantitative polymerase chain reaction (qPCR) tests taken one week apart or one single measurement with >= 1000 copies.
Patients with criteria of probable or definitive adenoviral diseases.
A response of at least 4 on a 10 point scale (with 0 = not tired at all and 10 = extremely tired) to the question “how tired did you feel in the past week?”
Uncontrolled hematuria
Patients with inherited syndromes associated with hypersensitivity to ionizing radiation (e.g., ataxia-telangiectasia, Nijmegen breakage syndrome)
For inclusion in the optional PGx research, patients must provide informed consent for the genetic sampling and analyses.
Active or recent thrombolic events
Asymptomatic or minimally symptomatic disease.
Arrhythmias requiring class Ia and III antiarrhythmics and/or grade >= 2 bradycardia
Prior elotuzumab
Invasive malignancy that require active systemic chemotherapy or biologics that may cause significant drug-drug interaction with either vemurafenib or obinutuzumab
Presence of any bladder or urethral anatomic feature that in the opinion of the Investigator may prevent the safe placement, indwelling use, or removal of TAR-200.
Pyeloureteral tube externalized to the skin (ureteral stent or unilateral nephrostomy tube is allowed).
Has a diagnosis of von Hippel Lindau disease, based on a germline VHL alteration
Patients must have a confirmed heterozygous TET2 mutations identified by next generation targeted deep sequencing
Hx or condition related to thrombosis, embolism or vascular occlusion/ischemia, including but not limited to: TIA, stroke, MI, stent placement, valve replacement and/or repair
Currently with an active acute infection, or suspected infection, a single oral temperature of ? 101° F or a temperature of ? 100.4°F sustained over a 1 h period in past 24 h. Subjects on prophylactic antibiotics are not excluded from study
Coagulopathy or receiving anticoagulants that result in PT or aPTT values greater than 1.3 X upper limit of normal or elevated D-dimer of decreased fibrinogen
Receipt of tranexamic acid or other antifibrinolytics within 48 hrs prior to infusion
Impaired wound healing capacity defined as skin/decubitus ulcers, chronic leg ulcers, known gastric ulcers, or unhealed incisions
Research participants with new symptoms of CHF, cardiomyopathy, myocarditis, MI, or exposure to cardiotoxic medications must have a cardiac consultation, creatinine phosphokinase (CPK), and troponin testing at pre -study and as clinically indicated
If the research participants has new symptoms of CHF, cardiomyopathy, myocarditis, MI, or exposure to cardiotoxic medications they already had a cardiac consultation, creatinine phosphokinase (CPK), and troponin testing at pre study deeming them fit for study participation
Prior olaratumab therapy must have been received with doxorubicin as indicated on the olaratumab label.
Prior olaratumab therapy must have included at least 2 full cycles of olaratumab/doxorubicin (that is, a minimum of 4 doses of olaratumab).
Participants, who completed at least 2 cycles of combination olaratumab/doxorubicin therapy then discontinued doxorubicin due to toxicity or maximum dosing and proceeded to olaratumab monotherapy, are eligible.
History of sun hypersensitivity and photosensitive dermatoses including porphyria, systemic lupus erythematosus, Sjögren's syndrome, xeroderma pigmentosum, polymorphous light eruptions or radiation therapy within 30 days of enrolling.
Unhealed sunburn.
Monocularity
Contact lens dependent (if using contact lens, must be able to switch to glasses during the entire study duration)
Uncontrolled glaucoma (topical medications allowed)
Uncontrolled or evolving retinopathy, wet macular degeneration, uveitis, papilledema, or optic disc disorder
Willingness and ability of patients to report selected study outcomes (e.g., GHS and HRQoL) using an electronic device or paper backup questionnaires.
M1 NED RCC participants who present not only with the primary kidney tumor but also solid, isolated, soft tissue metastases that can be completely resected at one of the following: the time of nephrectomy (synchronous) or, ?1 year from nephrectomy (metachronous).
Has residual thrombus post nephrectomy in the vena renalis or vena cava.
Combo C :Existing periorbital edema.
Ascites requiring non-pharmacologic intervention or escalation in pharmacologic intervention to maintain symptom control, within 6 months prior to the first scheduled dose
Drugs with known renal toxicity (e.g. vancomycin, amphotericin B, acyclovir, cyclosporin, methotrexate, tacrolimus) should be avoided to the extent possible during the 5 days of clofarabine treatment in each cycle or, if required, administered cautiously and with close monitoring
Participant must be considered ineligible for induction therapy defined by the following: a. >= 75 years of age; or b. >= 18 to 74 years of age with at least one of the following comorbidities: i. Eastern Cooperative Oncology Group (ECOG) Performance Status of 2 or 3; ii. Cardiac history of Congestive Heart Failure (CHF) requiring treatment or Ejection Fraction <= 50% or chronic stable angina; iii. Diffusing capacity of the Lung for Carbon Monoxide (DLCO) <= 65% or Forced Expiratory Volume in 1 second (FEV1) <= 65%; iv. Creatinine clearance >= 30 mL/min to < 45 ml/min; v. Moderate hepatic impairment with total bilirubin > 1.5 to <= 3.0 × Upper Limit of Normal (ULN); vi. Any other comorbidity that the physician judges to be incompatible with intensive chemotherapy must be reviewed and approved by the AbbVie Therapeutic Medical Director during screening and before study enrollment.
Participant has history of myeloproliferative neoplasm (MPN) including myelofibrosis, essential thrombocythemia, polycythemia vera, chronic myeloid leukemia (CML) with or without BCR-ABL1 translocation and AML with BCR-ABL1 translocation.
New onset moderate or severe cGVHD as defined by the 2014 NIH Consensus Development Project Criteria
Biomarker-positive for deoxyribonucleic acid (DNA)-repair anomalies
Women 18 years of age or older, who are either: Postmenopausal or Pre/perimenopausal women with medically-induced menopause by treatment with agents to induce chemical menopause.
Patients must have no evidence of significant mass effect, no midline shift, and no uncontrolled clinical signs of mass effect
Locally-advanced or metastatic malignancy with an NTRK1, NTRK2 or NTRK3 gene fusion, identified through molecular assays as routinely performed at CLIA or other similarly-certified laboratories.
Biopsy-proven HSIL (anal intraepithelial neoplasia 2 [AIN2] with a positive p16 stain, AIN 2-3, or AIN3) of the anal canal at either the squamocolumnar junction or distal anus, documented within 60 days prior to enrollment, but not less than 7 days prior to randomization
HSIL comprising 2 or more lesions, or anal HSIL in at least 2 octants, or anal HSIL that has recurred or is persistent after prior ablative treatment\r\nNote: HSIL should be in the anal canal at either the squamocolumnar junction or distal anus on HRA at screening or randomization; the extent of HSIL should be based on available biopsy results and visual appearance
Condyloma occupying more than 50% of the circumference of the anal canal or that obscures a satisfactory exam
Treatment for anal or perianal HSIL, low-grade squamous intraepithelial lesion (LSIL) or condyloma within 4 months of randomization; please note that infrared coagulation (IRC) or electrocautery of a biopsy site to stop bleeding does not constitute treatment
Patients must be off all colony-forming growth factor(s) for at least 1 week prior to registration (filgrastim, sargramostim, erythropoietin) and at least 2 weeks for long-acting formulations
Severe cardiopulmonary disease precluding the use of the minimally invasive technique as deemed by Internal Medicine Preoperative Assessment, Consultant and Treatment (IMPACT)
Histological confirmation of adrenocortical carcinoma (ACC) based on either: i). Weiss Score of >= 3 in patients who had earlier surgical resection OR ii). biopsy results compatible with ACC in the context of clinical setting highly suggestive of ACC (adrenal mass > 4 cm invading surrounding organs or associated with distant metastases).
For mitotane treated patients, mitotane should have been stopped at least 28 days prior to study enrollment AND to have mitotane serum level of < 2 mg/L.
Prior radium Ra 223 dichloride
Orchiectomy
Metastases that in the judgment of investigator-radiologist are not amenable to SBRT
Presence of metastatic disease that can be biopsied by any methodology applicable
Tumor specimen obtained prior to treatment initiation by interventional radiology guided biopsy will be interrogated per immunohistochemistry (IHC) and features should be as follows for a patient to be eligible \r\n* Overexpression of androgen receptor (AR)-C terminal and AR-N terminal and PTEN with lack of ARV7 expression along with and ki67 =<10%\r\n* No RB loss or p53 mutation and \r\n* No expression of neuroendocrine markers CD56 and chromogranin (all markers assessed by standardized IHC protocols)
Have used or plan to use from 30 days prior to enrollment (day 1 visit) through the end of the study the following medications known to lower the seizure threshold: \r\n* Aminophylline/theophylline\r\n* Atypical antipsychotics (e.g., clozapine, olanzapine, risperidone, ziprasidone)\r\n* Bupropion\r\n* Insulin\r\n* Lithium\r\n* Pethidine\r\n* Phenothiazine antipsychotics (e.g., prochlorperazine [compazine], chlorpromazine, mesoridazine, thioridazine)\r\n* Tricyclic and tetracyclic antidepressants (e.g., amitriptyline, desipramine, doxepin, imipramine, maprotiline, mirtazapine)
Troponin-I =< ULN
Brain natriuretic peptide (BNP) =< ULN
IDH 1 & 2 mutations status known
Subjects with clinically significant signs of uncal herniation, such as acute pupillary enlargement, rapidly developing motor changes (over hours), or rapidly decreasing level of consciousness, are not eligible
Confirmed diagnosis of primary cold agglutinin disease (CAgD) based on the following criteria: a) Chronic hemolysis, b) Polyspecific direct antiglobulin test (DAT) positive, c) Monospecific DAT strongly positive for C3d, d) Cold agglutinin titer >= 64 at 4 degree Celsius, and e) Immunoglobulin G (IgG) DAT less than or equal to (<=) 1+, and, f) No overt malignant disease
Significant post lumpectomy complications requiring an unplanned re-operation or admission for intravenous (IV) antibiotics; re-operation for margins evaluation or nodal evaluation is acceptable
Partial thromboplastin time (PTT) WNL+/- 15 % unless on active anticoagulation (suggested to be drawn peripherally to prevent port drawn elevation due to routine heparin flush of ports) obtained ? 14 days prior to randomization
Consent to receive FMT administered endoscopically (colonoscopically) and undergo necessary bowel preparation pre-procedure\r\n* Understand infectious risks associated with FMT administration; although FMT infusate has been screened for bacteria, viruses, fungi and parasites there is a risk of transmission of known and unknown infectious organisms contained in the donor stool; post-FMT bacteremia (e.g. E. coli), sepsis and fatal events may rarely occur\r\n* Understand non-infectious risks associated with FMT administration\r\n** Possible allergy and/or anaphylaxis to antigens in donor stool\r\n** Theoretical risk of developing disease possibly related to donor gut microbiota including but not limited to: obesity, metabolic syndrome, cardiovascular disease, autoimmune conditions, allergic/atopic disorders, neurologic disorders, psychiatric conditions and malignancy\r\n* Understand risks associated with colonoscopy including risk of infection transmission, colonic perforation, aspiration pneumonia, and death\r\n* Understand that data regarding the long-term safety risk of FMT are lacking
Presence of absolute contra-indications to FMT administration\r\n* Toxic megacolon\r\n* Severe dietary allergies (e.g. shellfish, nuts, seafood)\r\n* Inflammatory bowel disease\r\n* Anatomic contra-indications to colonoscopy
Ability to understand and follow the breathing instructions involved in the respiratory gating procedure or to tolerate compression sufficient to reduce fiducial motion to <= 5mm.
Requirement for concurrent treatment with nitrates or other drugs that may, in the judgment of the treating investigator, create a risk for a precipitous decrease in blood pressure.
Patients with either diffuse (> 1 quadrant or > 5 cm) suspicious microcalcifications on mammogram or diffuse non-mass-like enhancement on MRI
First detectable AdV DNA plasma viremia since the qualifying transplant occurred within 21 days prior to Day 1.
AdV DNA plasma viremia of ? 1,000 copies/mL and rising, defined as two consecutive results ? 1,000 copies/mL from the designated central virology laboratory, with the second result being greater than the first.
> 1 hospital admission for infection in prior 6 months
Has current or a history of any distant metastatic disease (including brain); an isolated or oligo-metastatic regional recurrence may be allowed if all other criteria are met, curative attempt is being pursued and if PI approval is granted
Diagnosed with Acute Hepatic Porphyria (Acute Intermittent Porphyria, Hereditary Corproporhyria, Variegate Porphyria, ALA dehydratase deficient porphyria)
Have active disease, with at least 2 documented porphyria attacks within the last 6 months
Completion of the OPN-305-106 study
Principal Investigator adjudicated efficacy response defined as either transfusion independence\, \stable disease\, \minor HI-E response\ or \major HI-E response\ and in the opinion of the Principal Investigator the patient may benefit from continued treatment with OPN-305 monotherapy or combination treatment with azacitidine.
Lack of available therapist/clinic,
Uncontrolled hyperthyroidism or parathyroidism (for which endocrinologist recommends against neck compression).
Acute radiation dermatitis, unhealed surgical scar, unhealed or open wound(s), surgical flap less than 6-8 weeks post-operative.
Acute facial infection (e.g., facial or parotid gland abscess).
Any condition in which increased venous and lymphatic return is undesirable.
Patients receiving any other investigational or commercial agents or therapies administered with the intention to treat their malignancy within 14 days of first receipt of study drug with the exception of: hydroxyurea (HU) in patients who need to continue this agent to maintain WBC count =< 50,000/mm^3
Distant metastatic disease of peritoneum: \r\n* Positive peritoneal cytology.\r\n* Carcinomatosis on diagnostic laparoscopy or laparotomy.
Subjects with a known hypersensitivity to protocol systemic chemotherapy that was life-threatening, required hospitalization or prolongation of existing hospitalization, or resulted in persistent or significant disability or incapacity.
The hepatic requirements may be waived for patients with grade 1 or 2 elevations of hepatic transaminases clearly due to leukemic infiltration after consultation with a study co-chair
Tumor is not impinging on Middle Cerebral Artery/speech-motor strip
BUN >30 in conjunction with a creatinine >2.
Patients must have the HA-1(H) genotype (RS_1801284: A/G, A/A)
The presence of organ toxicities will not necessarily exclude patients from enrolling on the protocol at the discretion of the PI; however, a delay in the infusion of HA-1 TCR T cells may be required
Unrelated donor residing outside of the United States of America (USA)
Subjects with clinically significant signs of uncal herniation, such as acute pupillary enlargement, rapidly developing motor changes (over hours), or rapidly decreasing level of consciousness, are not eligible
Patient has history of or currently has non-peritoneal surface macroscopic metastatic disease in addition to peritoneal surface malignancy such as macroscopic pulmonary disease or other macroscopic disease outside of the peritoneal cavity
Patients must meet the Thomas Jefferson University Hospital (TJUH) bone marrow transplant (BMT) standard of procedure (SOP) guidelines for “Patient Criteria for Autologous HSCT”
Patients must have undergone stem cell mobilization with the combination of G-CSF and plerixafor as per TJUH BMT SOP guidelines
Any surgical intervention for benign prostatic hypertrophy;
Anticoagulant drugs (e.g., warfarin) that could not be withdrawn during the 10 days prior to the VTP procedure or antiplatelet drugs (e.g. aspirin) that could not be withdrawn during the 10 days prior to the VTP procedure and 3 days after VTP;
Clinical symptoms (e.g., dyspnea or cough) consistent with BOS of ? 2 months duration
Diagnosis of BOS by one of the following criteria\r\n* Transbronchial or surgical lung biopsy demonstrating the obliterative bronchiolitis lesion\r\n* Volumetric computed tomography (CT) scan with lung density analysis with ? 28% air trapping\r\n* National Institutes of Health (NIH)-based PFT criteria for the diagnosis of BOS: FEV1/FVC < 0.7 and FEV1 < 75% \r\n* Evidence of clinical improvement after treatment for BOS initiated
Multiple immune suppressive medications are routinely used in patients after HCT with cGVHD and will be allowed to continue while participating in this study; these concomitant medications include but are not limited to: tacrolimus, sirolimus, ibrutinib, corticosteroids, mycophenolate mofetil, ruxolitinib, vismodegib, cyclosporine, montelukast, azithromycin, corticosteroids inhalers including those with a long acting beta-agonist (e.g., salmeterol); additional medications and therapies (e.g., extracorporeal photophoresis) for the intentional treatment of BOS will be permitted at the discretion of the provider; prophylactic antimicrobials including trimethoprim/sulfamethoxazole, azole class of antifungals, and acyclovir will also be allowed
There are no gender or race-ethnicity-based restrictions
Inability to perform PFTs
Prior exposure to agents targeting IL-6 or the IL-6 receptor
Symptoms of urogenital atrophy including dyspareunia or vaginal dryness
Vaginal stenosis which would not allow vaginal probe to be placed (based on physician exam)
Patients must agree to be randomly assigned to either intervention or control group
Men with > 5 bony metastases
Received systemic therapy with radionuclides (e.g., strontium-89, samarium-153, rhenium-186, or rhenium-188, or radium Ra 223 dichloride) for the treatment of bony metastases
Fecal incontinence
Metastatic melanoma or epithelial cancer with at least one lesion that is resectable or in selected cases, available peripheral blood mononuclear cells (PBMCs)
Subject who is unwilling to minimize exposure with his/her blood or other body fluids to individuals who are at higher risks for herpes simplex virus (HSV)-1 induced complications such as immunosuppressed individuals, individuals known to have HIV infection, pregnant women, or children under the age of 1 year, during talimogene laherparepvec treatment and through 30 days after the last dose of talimogene laherparepvec are ineligible
Patients who are unable to get MRIs due to any reason including pacemakers or automatic implantable cardioverter-defibrillator (AICD) are ineligible
Any prior chemoradiotherapy is allowed
Patients must have undergone puberty at the time of study entry to allow pre-transplant fertility preservation to occur, if desired; puberty will be defined as Tanner III or more in male patients (typically age >= 13 years) and menarche in female patients
Patients with hyperbilirubinemia as a consequence of hyperhemolysis or who experience a sudden, profound change in the serum hemoglobin after a RBC transfusion are not excluded
Tumors with known IDH1 (isocitrate dehydrogenase 1) or known IDH2 mutations as determined by immunohistochemistry for the IDH1 R132H variant or by direct sequencing
Urinary N-telopeptide level above 40 nM bone collagen equivalent (BCE)/mM creatinine measured at ARUP
Any atrophic macular condition including intermediate or advanced age-related macular degeneration
Use within 28 days of registration of calcitonin, recombinant parathyroid hormone-related peptides, mithramycin, radium, strontium ranelate, or gallium nitrate
Must have a growing tumor amenable to percutaneous image-guided cryoablation based on routine Interventional Radiology criteria
SSA therapy is recommended by physician for disease management, and has not yet begun
Morphological or cytological features of myelodysplasia and/or post-chemotherapy aplasia on BM assessment;
Myopathy > grade 2 or any clinical situation that causes significant and persistent elevation of CPK (>2.5 x ULN in two different determinations performed one week apart);
Patients must agree to consent to the companion genomic profiling study MSK IRB 12-245
Willingness to travel to the CTSC at WCMC weekly
History of nephrolithiasis or nephrolithiasis including that incidentally discovered during computed tomography (CT) screening
Vegetarian or vegan eating habits
Gum chewing habit
Have received prior treatment with olaratumab, doxorubicin, or ifosfamide, or have participated in other trials investigating olaratumab.
Photosensitivity disorder, including but not limited to porphyria, or concomitant photosensitizing drugs that place the patient at an elevated risk of developing severe side effects to PDT or RT
Patients who have had > 1 LHRH agonist or antagonist depot injection or received depot injection > 30 days before study entry.
Patients receiving medications known to lower the seizure threshold are ineligible unless discontinued or substituted at least 4 weeks prior to study entry. These include: 1) aminophylline/theophylline; 2) atypical antipsychotics (e.g., clozapine, olanzapine, risperidone, ziprasidone); 3) bupropion; 4) lithium; 5) pethidine; 6) phenothiazine antipsychotics (e.g., prochlorperazine (compazine), chlorpromazine, mesoridazine, thioridazine); 7) tricyclic and tetracyclic antidepressants (e.g., amitriptyline, desipramine, doxepin, imipramine, maprotiline, mirtazapine).
Estrogens, progestational agents such as megestrol, medroxyprogesterone, diethylstilbestrol (DES), cyproterone, spironolactone > 50 mg/kg, etc. unless discontinued at least two weeks prior to randomization.
Patients of any gender, race or ethnicity
Have a CAR T cell product likely to meet release criteria based on available in-process testing, as reviewed and acknowledged by the individual(s) listed on the protocol’s delegation of authority log who are authorized to make this determination
Patients who have tumors for which the Gd-enhancing mass appears to be covered =< 90% using 2 catheters and assuming a 3.0 cm diameter based on pre-operative planning are unlikely to have adequate LITT and thus ineligible for the study
A pathologically confirmed (histology or cytology) malignant neoplasm with at least one target lesion that is confirmed by conventional imaging and is determined to express somatostatin receptors by 68Ga-DOTATOC (TATE) PET within 6 months prior to treatment with 90Y-DOTATOC
Completion of Norfolk Quality of Life Questionnaire
Prior PRRT with 90Y-DOTATOC (TATE) or 177Lu-DOTATOC (TATE) or 131I-MIBG therapy for this malignancy
Any subject for whom, in the opinion of their physician, a 12-hour discontinuation of somatostatin analogue therapy represents a health risk; also subjects who have received sandostatin long-acting release (LAR) in the past 28 days or long-acting lanreotide within the past 8 weeks are excluded; subjects may be maintained on short acting octreotide during the time from last injection of long-acting somatostatin analogue until 12 hours (hrs) prior to injection of study drug; known antibodies to octreotide, lanreotide, or DOTATOC or history of allergic reactions attributed to compounds of similar chemical or biologic composition to 90Y-DOTATOC
Alpha 1,3 galactose IgE (“alpha gal”) < 0.35 IU/ml or “negative” within 10 days prior to “on study” status
Participants with AML (20%-30% blasts) must have a treatment-related mortality (TRM) score >=4 for intensive, induction chemotherapy as calculated using the simplified model described by Walter and coworkers. Calculation of TRM score:
Comorbidities.
>= 1 osseous and/or extra-osseous lesion that can be radiated
Solitary plasmacytoma
Confirmed diagnosis of sickle cell disease by hemoglobin electrophoresis or high-performance liquid chromatography (HPLC) [performed locally]. All sickle cell disease genotypes are eligible.
Participating in a chronic transfusion program (pre-planned series of transfusions for prophylactic purposes)
Has received prior immunotherapy including anti–PD-1, anti–PD-L1, or anti–PD-L2 agents, or if the subject has previously participated in Merck pembrolizumab clinical trials
Histological confirmation of biopsy-proven peripheral T-cell leukemia/lymphoma consistent with ATLL\r\n* Included subtypes will be: acute, lymphomatous, and chronic unfavorable; chronic unfavorable is defined as the chronic variant with at least one of the following: lactate dehydrogenase (LDH) > upper limit of normal (ULN), blood urea nitrogen (BUN) > ULN, albumin < lower limit of normal (LLN)\r\n* Positive HTLV-1 antibody testing with confirmatory testing via western blot, enzyme-linked immunosorbent assay (ELISA), or molecular testing (polymerase chain reaction [PCR])
Prior treatment: Previously untreated or has received a maximum of one cycle of any combination chemotherapy (e.g. cyclophosphamide/hydroxydaunorubicin/oncovin/prednisone [CHOP], cyclophosphamide/hydroxydaunorubicin/oncovin/etoposide/prednisone, [CHOEP], dose-adjusted etoposide/vincristine/doxorubicin/cyclophosphamide/prednisone [DA-EPOCH], cyclophosphamide/oncovin/doxorubicin/methotrexate-ifosfamide/VePesid/AraC [CODOX-M/IVAC], hyper cyclophosphamide/dexamethasone/doxorubicin/vincristine [CVAD]) within 4 weeks of study entry; additionally, a patient may have taken antiretroviral therapy (e.g. zidovudine [AZT] and/or interferon [IFN]) at any time prior to study enrollment
Patients between ages 18 and 80
Patients with evidence of significant arterial insufficiency or microangiopathy in any organ due to any reason, which could lead to distal extremity hypoxia, as evidenced by any gangrenous change in distal limbs or requiring resection for this reason.
Arterial anatomy which would preclude selective transarterial chemoembolization
Patients with extrahepatic metastases
Subjects must have histologically or cytologically confirmed EBV-positive LPD or an EBV-positive NHL confirmed by the Laboratory of Pathology, National Cancer Institute (NCI)\r\n* Cohort 1: EBV-positive B-cell LPD; subjects may be previously untreated or relapsed from prior therapy\r\n** Lymphomatoid granulomatosis (LYG), grades I-II\r\n** Chronic active EBV disease (CAEBV)\r\n** EBV-positive post-transplantation lymphoproliferative disorder (PTLD); NOTE: PTLD after solid organ transplantation is excluded; patients who, at the discretion of the investigator, need urgent therapy with standard agents will not be eligible\r\n* Cohort 2: EBV-positive B-cell NHL subjects must have relapsed from previous treatment with an anthracycline and rituximab-based regimen or be considered not eligible for the same\r\n** Lymphomatoid granulomatosis (LYG), grade III\r\n** EBV-positive immunodeficiency-associated diffuse large B-cell lymphoma (DLBCL)\r\n** EBV-positive DLBCL
Females of Childbearing Potential (FCBP) and male subjects who have reached puberty (and when applicable, with parental/legal representative) must agree to undergo physician-approved reproductive education and discuss the side effects of the study therapy on reproduction.
Cardiac stage 2 or 3 with N-terminal prohormone (NT-pro)-B-type natriuretic peptide (BNP) > 8500 ng/L
Treatment with Somatostatin analogs injections (octreotide or lanreotide) for at least 6 months with a stable dose for at least the last three months of therapy
Biochemically controlled
Symptomatic cholelithiasis
Metastatic lesions targeted for treatment must be located in the thoracic and/or lumbar vertebral body(ies), periacetabulum, iliac crest, and/or sacrum OR benign bone tumors (Europe and Canada only) - no restrictions on location of lesion
If group 1 is not filled, patients may proceed onto treatment without the completion of tests for DNA repair status; once group 1 is filled, patients cannot be enrolled onto the study or start treatment until DNA damage repair status is successfully determined for study group placement\r\n* Patients will be replaced if:\r\n** They have tissues that are not evaluable for mutations or the expression signatures\r\n** They do not have mutations associated with DNA repair and their expression signature is not evaluable
Have either:
Unable to undergo an 18F-DOPA-PET scan (e.g., Parkinson’s disease, taking anti dopaminergic, or dopamine agonist medication or less than 6 half-lives from discontinuance of dopamine agonists)\r\n* Note: Other potentially interfering drugs: amoxapine, amphetamine, benztropine, buproprion, buspirone, cocaine, mazindol, methamphetamine, methylphenidate, norephedrine, phentermine, phenylpropanolamine, selegiline, paroxetine, citalopram, and sertraline); if a patient is on any of these drugs, list which ones on the On-Study form
Hepatitis B or C seropositivity with evidence of ongoing liver damage, which would increase the likelihood of hepatic toxicities from the chemotherapy conditioning regimen and supportive treatments; if there is a positive result in the infectious disease testing that was not previously known, the patient will be referred to their primary physician and/or infectious disease specialist
Sodium >= 130 mEq/L
Patients with a known ROS-1-rearrangement must have progressed or been intolerant to treatment with crizotinib or entrectinib
Ability to discriminate intensity of thermal stimuli using QST.
Presence of an IT shunt.
Evidence of an infection within 7 days of planned injection.
Systolic >= 80
Prior WBRT
MMSE < 24
Participants with local conditions or systemic illnesses that would reduce the local tolerance to radiation treatment, such as serious local injuries, active collagen vascular disease, etc
Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 that will not undergo SRT and that is amenable to monitoring\r\n* Note: All brain metastases will receive SRT; therefore, a patient with brain metastases that will be treated with SRT must also have extracranial disease that will not undergo SRT and that is amenable to monitoring
PHARMACODYNAMIC EXPANSION COHORT: Consent to allow mandatory paired (pre- and on- treatment) fresh tissue biopsies if deemed safe to do so for quantitation of Akt pathway signaling proteins
Must have had a diagnostic mammogram performed within the last 6 months
CHEMOTHERAPY/CELL INFUSION ELIGIBILITY: Patients must have adequate TIL available as per Moffitt Cell Therapies current standard operating procedures (SOP)
At least one RAI-avid lesion identified on the most recent radioiodine scan (a diagnostic, post-therapy, or post-ablation scan) prior to study registration; (both RAI-sensitive and RAI-refractory patients are eligible if at least one tumor with RAI avidity of any degree can be identified within these parameters)
Agrees to the placement of an intraperitoneal port before the start of chemotherapy and remains in place through day 28 or longer
Disease outside of the peritoneal cavity
Patients must be CTC positive (defined as CTCs >= 5)
Histologically or cytologically confirmed HER2-positive (3+ by IHC or amplified by FISH) according to ASCO/CAP guidelines\r\n* Note: A HER2 result of 2+ by ICH is equivocal and requires a reflex test (same specimen using the alternative test) or new test (new specimen, if available, using same or alternative test)
Overweight or obese
Priority for members of a minority group
Note: transfusions are permitted to meet these platelet and hemoglobin criteria if the reason for the cytopenias are judged to be secondary to marrow involvement with tumor per principal investigator (PI) or PI designee
Any other ongoing serious medical problem unrelated to cancer or its treatment that is not covered by the detailed exclusion criteria and which is expected to interfere with the anti-tumor effect of infused EA-NK cells or the action of hu14.18-IL2 or to significantly increase the severity of the toxicities experienced from this immunotherapy regimen
Enrollment in any other treatment studies that would interfere with the endpoints of this study from screening up to 28 days after the last immunotherapy (EA-NK cells or last infusion of hu14.18-IL2) in the opinion of the PI or PI designee is not permitted
Patients with unhealed surgical wounds for more than 30 days
PHEO/PGL that is associated with the SDHx mutations or is not associated with any known susceptibility genetic mutations for PHEO/PGL (a.k.a. “apparent sporadic”), based on documented genetic testing results obtained prior to study enrollment; PHEO/PGL that is associated with non-SDHx mutations such as VHL, NF1, and RET will not be eligible for this study
Prior transarterial chemoembolization (TACE) or radiofrequency ablation (RFA) allowed, however, patient must have separate intrahepatic lesion amenable to SBRT and biopsy
History of hypersensitivity to alectinib or any of its excipients; in addition, subjects who are unable to tolerate the 600 mg twice daily BID dose of alectinib will not be permitted to enroll unless doses of alectinib below the entry level are being investigated (e.g. dose level -1 and -2) and they have previously tolerated alectinib monotherapy at the dose being investigated
Patients who have previously been treated with another agent targeting the MUC20/c-Met axis, including either monoclonal antibodies to MUC20 or c-Met, or small molecule inhibitors of c-Met
Active and inactive vaccinations within 4 weeks of the first dose of avelumab and while on trial is prohibited
Patients with known congenital heart defects
Consented for genome sequencing and dbGAP-based data sharing
Subjects with a strong likelihood of non-adherence such as difficulties in adhering to follow-up schedule due to geographic distance from the Siteman Cancer Center should not knowingly be registered
Individuals in whom a skinfold measurement of the cutaneous and subcutaneous tissue for eligible injection sites (left and right medial deltoid region) exceeds 40 mm
Individuals in whom the ability to observe possible local reactions at the eligible injection sites (deltoid region) is, in the opinion of the investigator, unacceptably obscured due to a physical condition or permanent body art
Signs or symptoms of life-threatening raised intracranial pressure: as defined by the treating neurosurgeon, including severe headache, nausea, decreasing level of consciousness, precluding 4-7 day delay in scheduling neurosurgery
The presence of disease that can be biopsied for research purposes is not an inclusion criterion
Have been treated on any Merck-sponsored pembrolizumab-containing gastric cancer pivotal trial will require prior authorization by Merck in order to enroll in this study
Patients with major symptoms or impairments related to brain metastases, such as aphasia or severe confusion, will be excluded per principal investigator (PI) discretion when those symptoms preclude proper neurocognitive evaluation during the study treatment
Platelets > 100,000/µL. Patients with ? 100,000 platelet count may be allowed into the study on a case-by-case basis after consultation with the Medical Monitor.
Life expectancy < 6 months (as estimated per diagnosis-specific graded prognostic assessment [ds-GPA])
Urine protein (dipstick): negative or trace; in case of trace, a urinalysis has to be performed in the local laboratory and have to confirm that such abnormality is not to be considered clinically significant, according to the investigator's judgement
Known lactose intolerance.
Immunosuppression, of any kind
Uncontrolled hyper- or hypothyroidism
Diffuse bladder carcinoma in situ (CIS) that was not able to be encompassed in a boost radiotherapy volume
Recognized immunodeficiency condition including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; subjects who have acquired, hereditary, or congenital immunodeficiencies, including HIV infection or have been splenectomized.
Patients with fistula documented radiographically or by EDG/EUS, endobronchial ultrasound (EBUS)
No prior exposure to colony stimulating factor 1 receptor (CSF1R) antagonists such as but not limited to emactuzumab (RG7155) (Roche), PLX3397 (Plexicon), JNJ40346627 (Johnson & Johnson), including both anti-CSF1R and small molecule inhibitors and prostaglandin E2 receptor 4 (EP4) antagonists
Active hydronephrosis
Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.
Platelets (plts) > 100 x 10^9/L
FOR ALL PHASES (Ib AND II):
Histologically proven adrenocortical carcinoma (ACC) with the majority of disease confined to the peritoneal cavity and resectable or amenable to radiofrequency ablation; or disease that in the opinion of the investigators can be managed medically or surgically and does not present an immediate threat to the patient’s life
No prior cystectomy
Prior cystectomy
Individuals in whom a skinfold measurement of the cutaneous and subcutaneous tissue for eligible injection sites (left and right medial deltoid region) exceeds 40 mm
Individuals in whom the ability to observe possible local reactions at the eligible injection sites (deltoid region) is, in the opinion of the investigator, unacceptably obscured due to a physical condition or permanent body art
Exposure to household contacts =< 15 months old or household contact with known immunodeficiency
If previously exposed to irradiation, the combined prior and anticipated exposure for Cycle 1 is not expected to exceed organ exposure limits outlined in Table 2
MVT-5873 and MVT-2163 administered as part of a different protocol
Must be functionally and technically fit for partial laryngectomy. Subsite study candidates will be evaluated by enrolling physician. The assessment checklist will be submitted at time of enrollment and evaluated by Dr. Gross or Dr. Phan.
Patients who have undergone a diverting tracheostomy which is either a) traversing directly through tumor, b) has been placed for true airway insufficiency. Patients with a tracheostomy placed preemptively for impending airway compromise remain eligible for enrollment.
Patients requiring treatment with one or more medications known to interact adversely with digoxin, namely thiazide and/or loop diuretics, quinidine, ritonavir, amiodarone, cyclosporine, itraconazole, propafenone, spironolactone, verapamil
Patients with unhealed surgical wounds for more than 30 days
Patients for whom SABR plans cannot meet the minimum requirement of target coverage and dose-volume constraints of critical structures (see SABR treatment planning section) are not eligible
Willingness to avoid excessive sun exposure and use adequate sunscreen protection if sun exposure is anticipated
Patients with a diagnosis of NF1 and GIST who do not meet other eligibility criteria may enroll on the NF1 natural history study, and will be followed on this study; should they require therapy for GIST based on evidence of progression, they may then enroll on study
Patients who anticipate the need for surgical intervention within the first three cycles (3 months), as surgical intervention during the period of dose limiting toxicity (DLT) evaluation may affect analysis of adherence and/or make the subject inevaluable
For the sixteen patients who elect to participate in the optional technology portion involving electronic step counts and blood pressure monitoring, the patient must have a Bluetooth-enabled smart phone, which is compatible with the wireless health monitors
(For cohort B): Primary tumor sample collected before NACT started (on ARTEMIS) and underwent molecular testing for integral biomarkers including immunohistochemical assessment of FRalpha
Required used of folate-containing supplements (e.g. folate deficiency)
Successful collection of T cells for huJCAR014 manufacturing
Willing to refrain from using other lotions, creams, etc. during the treatment period;
Open or ulcerated wound(s) extending through the dermis within the treatment area;
Patients with phaeochromocytoma
Patients with known sensitivities to either cyclophosphamide and/or sirolimus
Patients with history of mild autoimmune disorders - including but not limited to - mild psoriasis or Hashimoto's hypothyroidism, may be included at the discretion of the principle investigator.
Frequent vomiting.
Current (within 1 week of Screening) or regular use of any medication (including over-the-counter (OTC), herbal or homeopathic preparations) that could improve or worsen the cancer being studied, or could affect the action or disposition of IT-141, or its clinical or laboratory assessment; e.g. Coumadin therapy, due to high competitive protein binding. Subjects taking ANY supplemental IRON, i.e., therapeutic or as part of a multivitamin regimen, are excluded from this study, whether prescribed or self-medicated.
Willing to comply with protocol therapy and required safety monitoring (self-report, pulse oximetry, remote spirometry, labs)
Must have had a nephrectomy (radical or partial) and must provide the cell block from the nephrectomy
Subradiographic and/or cytopathologic evidence of peritoneal carcinomatosis found at staging laparoscopy\r\n* Documentation of cytopathologic diagnosis of malignant peritoneal cytology in the absence of disseminated peritoneal disease must be obtained; if cytologic analysis reveals atypical cells of undetermined significance, a repeat lavage with cytopathologic analysis will be performed and must demonstrate evidence of malignancy\r\n* Limited peritoneal involvement (=< P1 or peritoneal cancer index [PCI] < 10) found at staging laparoscopy or on final pathology that is deemed completely resectable is permitted
Disseminated extra-peritoneal or solid organ metastases\r\n* Includes carcinomatosis associated with clinically or radiographically evident ascites (greater than 500 cc)\r\n* Excludes greater omentum and ovarian metastases
The primary lesion must be accessible for endoscopic biopsy and injection as evaluated by a gastroenterologist at New York-Presbyterian (NYP)-Columbia; further, the patient must be deemed able to tolerate repeated endoscopy procedures by an anesthesiologist and/or gastroenterologist at NYP-Columbia
Nursing patients are not allowed on the study and women must commit to no lactation during the course of the study
Subject who is unwilling to minimize exposure with his/her blood or other body fluids to individuals who are at higher risks for herpes simplex virus (HSV)-1 induced complications such as immunosuppressed individuals, individuals known to have HIV infection, pregnant women, or children under the age of 1 year, during talimogene laherparepvec treatment and through 30 days after the last dose of talimogene laherparepvec
Patients with MRI or clinical evidence of uncontrolled tumor mass effect are excluded; the assessment of mass effect should be made by the study chair(s) and study neurosurgeon prior to any planned CED treatment
Able to retain bladder instillations for up to 120 minutes (± 15 minutes).
An indwelling ureteral stent.
Acute leukemias of ambiguous lineage
Acute or subacute intestinal occlusion;
In the opinion of the investigator, EUS directed implantation posing undue subject risk e.g. previous EUS-FNA was considered technically too difficult to perform, or imaging demonstrates multiple collateral vessels surrounding or adjacent to the target tumor
Patients must have elevated calcitonin levels greater than 40 pg/mL
Subject who is unwilling to minimize exposure with his/her blood or other body fluids to individuals who are at higher risks for human herpesvirus 1 (HSV-1) induced complications such as immunosuppressed individuals, individuals known to have HIV infection, pregnant women, or children under the age of 1 year, during talimogene laherparepvec treatment and through 30 days after the last dose of talimogene laherparepvec
? 18 to 74 years of age and fulfill at least one criteria associated with lack of fitness for intensive induction chemotherapy: i. Eastern Cooperative Oncology Group (ECOG) Performance status of 2 - 3; ii. Cardiac history of Congestive Heart Failure (CHF) requiring treatment or Ejection Fraction ? 50% or chronic stable angina; iii. Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) ? 65% or Forced Expiratory Volume in 1 second(FEV1) ? 65%; iv. Creatinine clearance ? 30 mL/min to < 45 ml/min; v. Moderate hepatic impairment with total bilirubin > 1.5 to ? 3.0 × Upper Limit of Normal (ULN); vi. Other comorbidity that the physician judges to be incompatible with conventional intensive chemotherapy which must be reviewed and approved by the study medical monitor before study enrollment.
Participant had an antecedent myeloproliferative neoplasm (MPN) including myelofibrosis, essential thrombocytosis, polycythemia vera, or chronic myelogenous leukemia (CML) with or without BCR-ABL 1 translocation and AML with BCR-ABL 1 translocation.
New or progressive pulmonary infiltrates concerning for new or uncontrolled infectious process
Tumor is not impinging on Middle Cerebral Artery/speech-motor strip
Agrees to take measures to avoid becoming pregnant during the study and
Patients who require anticoagulation, systemic steroids, statin therapy or beta-blocker therapy. The beta-blocker might compromise use of epinephrine for the rare possibility of anaphylaxis. Hypertension controlled by other agents does not disqualify, provided other criteria are met.
Only for subjects enrolled in Arm 3 - Neratinib and trametinib: all skin rash (dermatitis acneiform, erythema, xeroderma, eczema) should be at grade 1 when starting trametinib treatment.
Only for subjects enrolled in Arm 3 - Neratinib and trametinib: history of retinal disorder, dry eye syndrome, or blurry vision need to be evaluated by ophthalmology prior to starting treatment.
TP53 mutant relapsed/refractory AML following 7+3 (or similar cytarabine containing induction chemotherapy for AML) disease detected by one of the following methods:\r\n* Bone marrow blasts > 5%, or\r\n* Hematologics flow cytometry assay (threshold > 0.5%) (alternative equivalent assay may be substituted), or\r\n* Persistent cytogenetic abnormality (e.g. del5, del17p, etc) by fluorescence in situ hybridization (FISH) or conventional karyotyping, or\r\n* Persistent TP53 mutation (at least 5 variant reads with at least 50x coverage)
Willingness to sign medical records release form and tissue release form
Acute leukemias of ambiguous lineage
Somatostatin receptor (SSTR) positive sites as demonstrated by either SSTR2 positivity (2+ or 3+ intensity and greater than 10% tumor cell occupying the receptors) or a nuclear medicine scan utilizing 111In-DTPA-phe3-octreotide (Octreosca) or 68Ga-DOTA-tyr3-octreotide within 12 months prior to anticipated cycle 1 day 1 (C1D1) demonstrating SSTR positive tumor sites
Subjects must demonstrate at least one of the following:\r\n* One or more MIBG+ and DOTATOC- tumors in addition to one or more DOTATOC+ tumors\r\n* One or more tumor sites where the calculated \safe\ radiation tumor dose is higher by at least 25% with a combination of 131I-MIBG and 90Y-DOTATOC than it is with 90Y DOTATOC alone
Patients who are unable to discontinue medications known to affect MIBG uptake (unless approved by the principal investigator [P.I.] or designee)
Tumor mitotic rate > 20/10 high-power field (hpf) and/or Ki67 index > 20% (if available)
Patients with a diagnosis of agammaglobulinemia, that is:\r\n* Undetectable anti-tetanus toxoid immunoglobulin G (IgG)\r\n* Known history of agammaglobulinemia
Poor health literacy
Did not discontinue because of tolerability concerns.
Patients who occasionally or regularly use medications that impact dopamine receptor signaling and can cause side effects in people with neuroendocrine tumors including PC-PG such as metoclopromide, chloropromazine, prochlorperazine, droperidol, ephedrine, pseudoephedrine, fenfluramine, methylphenidate, phentermine, amitryptaline, imipramine, tranciproamine, moclobemide, phenelzine, paroexetine, and fluoxetine
Patients with active inflammatory processes including T max > 101 or active tissue inflammation are excluded up to and including the day of admission
All patients must have received prior conventional external-beam radiation therapy (cEBRT) to the site of interest to no more than a critical neural tissue dose equivalent dose (EQD)2/2 of 42 Gy in a single session or 50 Gy cumulative over multiple sessions and cauda equina dose EQD2/2 of 50 Gy in a single session or 60 Gy cumulative over multiple session
FULL STUDY INCLUSION CRITERIA: Hemoglobin (Hb) >= 8 g/dL, without blood transfusion or erythropoietin within 6 weeks before the start of study treatment\r\n* Note: patients receiving chronic low-dose erythropoietin for chronic renal failure are allowed provided no dose adjustment is undertaken within 6 weeks before signing consent for full study and until safety follow-up visit and provided that they fulfill conditions of eligibility criteria
Patients must not have symptoms attributed to mass effect of the tumor (despite corticosteroid treatment) that would be better treated with debulking surgery, or wherein surgical debulking in the first 30 days following LITT procedure would be anticipated for symptom management.
Patients at risk of brain perfusion problems, e.g., carotid stenosis • Uncontrolled hypertension requiring clinical intervention
Men who are expecting to father children within the research period
Specific mutations:
International Prognostic Index (IPI) score of 2-5
Demyelinating form of Charcot-Marie-Tooth disease
Histopathological diagnosis of amyloidosis based on detection by immunohistochemistry and polarizing light microscopy of green bi-refringent material in congo red stained tissue specimens (in an organ other than bone marrow) or characteristic electron microscopy appearance
NT-ProBNP > 8500 nanogram per liter (ng/L)
Known to be seropositive for hepatitis C (except in the setting of a sustained virologic response [SVR], defined as aviremia at least 12 weeks after completion of antiviral therapy)
Patients must be positive for the RARA super-enhancer associated biomarker or RARA pathway associated biomarker at the time of study screening.
Pure seminoma after orchiectomy presenting with isolated retroperitoneal lymphadenopathy OR stage I pure seminoma with isolated retroperitoneal relapse; relapse should be within 3 years
Serum alpha-fetoprotein (AFP) not greater than 1.5 times the upper limit of the local laboratory assay within 14 days of RPLND
Prior treatment with any pan-HER TKI (eg, lapatinib, afatinib, dacomitinib, neratinib).
GROUP 3: Diffuse scleroderma with disease duration =< 2 years since development of first sign of skin thickening plus modified Rodnan skin score >= 25 plus either\r\n* Erythrocyte sedimentation rate (ESR) > 25 mm/1st hour and/or hemoglobin (Hb) < 11 g/dL, not explained by causes other than active scleroderma\r\n* Lung involvement (either FVC or DLCO < 80% and evidence of interstitial lung disease by CT scan or alveolitis by BAL)
GROUP 5:\r\n* Limited cutaneous scleroderma and SSc-related pulmonary disease with FVC < 80% or hemoglobin-adjusted DLCO < 70% of predicted\r\n* AND evidence of alveolitis/interstitial lung disease by high-resolution chest CT scan and/or by BAL (interstitial lung disease may be nonspecific interstitial pneumonia [NSIP] or usual interstitial pneumonia [UIP]; A bronchoalveolar lavage [BAL] should be done to confirm the findings of alveolitis only if the high resolution CT scan [HRCT] fails to show findings typically associated with systemic sclerosis changes [ground glass, NSIP, UIP, SSc related interstitial lung disease])\r\n* Alveolitis by BAL cell count will be defined based on a BAL cell differential count (> 3% neutrophils and/or > 2% eosinophils) from any lavaged lobe
Must have MS/MMR result available at time of registration; MS/MMR status is to be determined per local practice (i.e. immunohistochemistry [IHC], polymerase chain reaction [PCR], or other methods)
Prior treatment with enfortumab vedotin or other monomethyl auristatin E (MMAE)-based antibody-drug conjugates (ADCs).
Patients must not be receiving any additional medicines being given for the specific purpose of treating cancer
a) Intraocular PCNSL without evidence of brain disease b) PCNSL patients who cannot undergo MRI assessments c) PCNSL patients with systemic disease
Consistent and correct usage of established oral contraception.
Monocularity
Visual acuity of 20/70 or worse in both eyes
Contact lens dependent (if using contact lens, must be able to switch to glasses during the entire study duration)
Uncontrolled glaucoma (topical medications allowed)
iC9-CAR19 CELL INFUSION: Corticosteroid use is contraindicated following iC9-CAR19 infusion unless medically necessary e.g., to treat CRS)
iC9-CAR19 CELL INFUSION: Severe systemic uncontrolled disease or toxicities that develop after lymphodepletion may prompt exclusion from cell infusion at the discretion of the investigator
Patients must be able to ingest oral medications (crushing and administering via percutaneous endoscopic gastronomy [PEG] tube is acceptable)
Approval for hydroxychloroquine treatment by an eye doctor, based on a screening eye exam; examples of disqualifying baseline conditions include macular degeneration and other retinal disease such as cataracts that would interfere with required funduscopic examinations, or severe baseline visual impairment, retinopathy or visual field changes, or having only one functional eye; all patients must undergo a screening eye exam prior to enrollment
Treatment-related mortality (TRM) score >= 13.1 as calculated with simplified model
Score greater than 7 on the Insomnia Severity Index and meet the criteria for insomnia disorder as defined by the Diagnostic and Statistical Manual of Mental disorders, 5th Edition (DSM-5) as assessed by the insomnia interview schedule
As per self report, heavy drinker (regularly having more than 14 alcoholic beverages per week)
As per self report, engaging in night shift work
As per self report significant needle phobia as to prevent participation in acupuncture
Measurable disease per modified severity weighted assessment tool (mSWAT) and/or Sezary count
GNRH agonists or GNRH antagonists (e.g., leuprorelin, degarelix) for > 2 months prior to consenting
Epidural analgesia
Failure to satisfy minimum criteria of lung shunting (> 20%) or presence of extrahepatic gastrointestinal activity on microaggregated albumin (MAA) scan or angiogram that preclude SIR-Spheres
M0
A concomitant medical condition requiring receipt of a therapeutic anticoagulant that in the opinion of the treating physician cannot safely allow for therapeutic injection of ONCOS-102 and tumor biopsies. Local clinical practice can be followed with regard to holding a therapeutic anticoagulant during invasive procedures such as biopsies.
Histologically confirmed adenocarcinoma of the small intestine that is advanced (not amenable to surgery) or metastatic (clinical stage IV); for the purposes of this study, ampullary tumors are considered a part of the duodenum and are classified as adenocarcinomas of the small intestine
Eligibility of patients receiving any medications or substances known to affect or with the potential to affect the activity or pharmacokinetics of ibrutinib or blinatumomab will be determined following review of their case by the investigator
IMMUNE RECONSTITUTION STUDY ONLY: Received haploidentical BMT with the current standard of two days of PT-CY (and no PT-BEN)
Active infection at time of hospital admission of haploidentical (Haplo) BMT
Requirement for concurrent treatment with nitrates or other drugs that may, in the judgment of the treating investigator, create a risk for a precipitous decrease in blood pressure
Myeloproliferative neoplasms/myelofibrosis
Patients with undetectable anti-tetanus toxoid IgG
Concurrent use of an angiotensin-converting enzyme (ACE) inhibitor (increased risk of angioedema with ACE inhibitors administered in combination with everolimus, seen in approximately 6.8% of patients)
Demonstrated willingness and ability to record daily caloric intake either on paper or in online program
Daily caloric consumption < 1000 calories
Inoperable on the basis of co-existent medical problems
Patient has history of clinically significant dry eye (xerophthalmia) or other corneal abnormality or, if a contact lens wearer, does not agree to abstain from contact lens use from day 0 through the last study drug dose
Unlikely to cooperate in the study.
Patients with Gilbert's syndrome or other heritable diseases of bile processing.
Patients must be in a major molecular remission (MMR) on a TKI (imatinib, dasatinib, nilotinib, or bosutinib) for a minimum of 1 year leading up to enrollment; major molecular remission is defined as BCR-ABL1 transcripts =< 0.1% by quantitative real time polymerase chain reaction (QPCR) (International Scale [IS]) or >= 3-log reduction in BCR-ABL1 messenger ribonucleic acid (mRNA) from the standardized baseline, if QPCR (IS) is not available\r\n* MMR must be documented on at least 2 occasions, at least 3 months apart, in the 6 to 12 months leading up to enrollment
Patients in complete molecular remission (CMR) on a TKI (imatinib, dasatinib, nilotinib, or bosutinib); CMR is defined as no detectable BCR-ABL1 mRNA by QPCR (IS) using as assay with a sensitivity >= 4.5 logs below the standardized baseline
Atypical BCR-ABL1 mRNA transcripts that cannot be monitored with QPCR
History of developing any condition during prior treatment with ramucirumab for which ramucirumab must be permanently discontinued according to the ramucirumab label.
The following are not counted as medical therapies: nephrectomy, radiation therapy, other energy-ablative techniques, or metastasectomy
Intolerance to infused protein products, sucrose, histidine or polysorbate 80
Patients may agree to provide optional paired biopsies.
Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial
Planned goal TSH suppression 0.1-0.5 mU/L for at least 18 weeks postoperatively
Planned postoperative TSH goal different than 0.1-0.5 mU/L
In the case of women, both pre/perimenopausal and postmenopausal patients are allowed to be included in this study; menopausal status is relevant for the requirement of goserelin to be used concomitantly with ribociclib and letrozole.
Premenopausal status is defined as either: I). Patient had last menstrual period within the last 12 months, OR ii). If on tamoxifen or toremifene within the past 14 days, plasma estradiol and FSH must be in the premenopausal range per local normal range, OR iii). In case of therapy induced amenorrhea, plasma estradiol and/or FSH must be in the premenopausal range per local normal range.
Perimenopausal status is define as neither premenopausal nor postmenopausal Note: Throughout this document, perimenopausal and premenopausal status is grouped together and referred as \Premenopausal\
Granulocytes >= 1,500/mcL
In subjects requiring biliary decompression, biliary stent or drainage using percutaneous transhepatic cholangiogram (PTC) are allowed
Has received prior immunotherapy including anti–PD-1, anti–PD-L1, or anti–PD-L2 agents, or if the subject has previously participated in Merck pembrolizumab clinical trials
Adequate baseline organ function defined by: International Normalization Ratio (INR) and activated partial thromboplastin time (aPTT) <=1.3xupper limit of normal (ULN); platelet count (PLT) >=10,000 (transfusions permitted to bring PLT to >10,000); total bilirubin <=1.5xULN (Isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35% or subject has a diagnosis of Gilbert's syndrome); Alanine transaminase (ALT) <=2.5xULN; creatinine <=1.5xULN OR calculated creatinine clearance by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation or measured from 24 hour urine >=50 milliliters (mL)/minute (min); and Ejection fraction >=lower limit of normal (LLN) by Echocardiogram (ECHO) or multigated acquisition scan (MUGA)
Paget’s disease of the nipple
The parent study is closed or planned to be closed; and
PB or BM basophils ?20%
Subjects who within 48 hours of randomization have used an anti-Factor IIa agent such as dabigatran or an anti-FXa agent such as rivaroxaban, apixaban, or edoxaban;
Treatment-related mortality (TRM) score =< 9.2 as calculated with simplified model
No evidence of an active malignancy that would limit the patient’s survival to less than 2 years. (If there is any question, the principal investigator [PI] can make a decision)
Creatinine ? 3.0 xULN
Progressing based on organ assessment after at least 3 days compared to organ stage at the time of initiation of high-dose systemic corticosteroid +/- CNI for the treatment of Grade II-IV aGvHD, OR
Failure to achieve at a minimum partial response based on organ assessment after 7 days compared to organ stage at the time of initiation of high-dose systemic corticosteroid +/- CNI for the treatment of Grade II-IV aGvHD,OR
Inadequate renal function, defined as calculated or estimated creatinine clearance < 60 mL/min unless lymphoma, KSHV-MCD, or KSHV-associated inflammatory cytokines syndrome (KICS)-related
Platelets < 75,000/mm^3 unless lymphoma, KSHV-MCD, or KICS-related
Patients requiring beta blockade are disqualified from participating in this study
Uncontrolled dysrhythmias or poorly controlled angina.
The Hepatobiliary Multidisciplinary Committee (HDMC) must approve of this intervention
The Hepatobiliary Multidisciplinary Committee (HDMC) disapproves of this intervention
Insurance will not cover the procedure
Written informed consent must be obtained prior to enrolling in the rollover study and receiving the study treatment. If consent cannot be expressed in writing, then the consent must be formally documented and witnessed, ideally via an independent trusted witness
Histologically confirmed residual ovarian cancer at time of second-look surgery; patients with cytological evidence of malignant cells in washings obtained as part of the second look procedure are eligible even if biopsies are negative
History of gastrointestinal or urinary fistulae, non-healed or chronic wound, or other conditions that, in the investigator’s view, would contraindicate or significantly increase the risks of bevacizumab therapy
Glaucoma
Acute myeloid leukemia (AML) in CR1 with intermediate or high risk features including:\r\n* Cytogenetic abnormalities associated with myelodysplastic syndrome including abnormalities of chromosome 5 or 7\r\n* History of anti-neoplastic therapy (radiation or chemotherapy)\r\n* Extramedullary involvement\r\n* WBC count >= 100,000 cells/uL at diagnosis\r\n* Rearrangements or mutations of 11q23 (MLL)\r\n* Abnormalities of chromosome 3\r\n* TP53 mutation or loss of 17p\r\n* Complex or monosomal karyotype \r\n* Normal karyotype with mutations of FLT3, RUNX1, or ASXL1
Mutational testing of patient samples for KIT and platelet-derived growth factor receptor (PDGFR) mutations; (this will not hold up starting therapy, but will be done for all patients lacking up front mutational testing)
Ability to understand and follow the breathing instructions involved in the respiratory gating procedure or to tolerate compression sufficient to reduce fiducial motion to =< 5 mm
Not adhering to pregnancy prevention recommendations
Allergic or unable to tolerate TMZ for any reason; any patient that successfully completed at least 5 weeks of Temodar during standard of care XRT/TMZ and whose blood counts meet the eligibility requirements within 4 weeks post XRT/TMZ is eligible
Concomitant treatment with the following drugs that may interact with S-1: Sorivudine, brivudine, uracil, eniluracil, folinate/folinic acid, Cimetidine, dipyridamole, and nitroimidazoles, including metronidazole and misonidazoleMethotrexate, Clozapine,Allopurinol,Phenytoin,Flucytosine, a fluorinated pyrimidine antifungal agent,Coumarin-derivative anticoagulant
Patients must have a bone marrow biopsy available, or one scheduled to be performed for a clinical indication so that survivin expression could be determined (note: survivin staining in tumor need not be resulted prior to enrollment or treatment as it is obtained for correlative science)
Common variable immunodeficiency
Prior taxanes for CRPC
Willingness to avoid excessive sun exposure and use adequate sunscreen protection if sun exposure is anticipated
Presence of third space fluid which cannot be controlled by drainage
Aspartate aminotransaminase (AST) and alanine aminotransaminase (ALT) =< 5 times ULN (within 14 days prior to registration)
Prior exposure to a short interspersed element (SINE) compound
Patients who are on the following drugs and cannot have a drug substitution: flecainide, methadone, amphetamines, quinidine, and chlorpropamide; Note: high dose ascorbic acid may affect urine acidification and, as a result, may affect clearance rates of these drugs
Demyelinating form of Charcot-Marie-Tooth syndrome
Disease must be technically amenable to transhepatic arterial chemoembolization (TACE) (HCC patients only), radiofrequency ablation (RFA), or cryoablation; each case will be discussed at gastrointestinal (GI) tumor board with interventional radiology; patients must have evaluable disease
Patients with unhealed surgical wounds for more than 30 days
FOR ALL ARMS OF THE PROTOCOL
Patients with ARDS resulting from trauma
Patients with prior pneumonectomy
Patients with exposed carotid artery preoperatively requiring sacrifice or bypass intra-operatively
Patients with active pharyngocutaneous fistula
met the screening criteria for CI through a positive response to at least 1 of 2 scaled questions from the European Organization for Research and Treatment of Cancer Quality of Life questionnaire (EORTC-QLQ) i.e. Please rate on a scale from 0 to 10, the difficulty level you have in concentrating on things, like reading a newspaper or watching television? \0\ means no difficulty and \10\ means very difficult. Please rate on a scale from 0 to 10, the difficulty level you have in remembering things. \0\ means no difficulty and \10\ means very difficult, will be included.
Confirmation of resectability by surgical oncology consultation
Short removable metal stents rather than plastic stents are strongly encouraged but not required for palliation of initial obstructive jaundice
Patient with known active herpes simplex virus infections (prior uncomplicated oral herpes simplex virus [HSV] lesions are not an exclusion), prior complications from HSV infections such as encephalitis, or who require systemic antiviral therapy at the time of study enrollment should be excluded
Patients should not be prescribed concomitant medications that may contribute to prolonged QTc without consultation with the chemotherapy pharmacist; additional ECGs should be done at the investigator’s discretion to ensure the subject’s safety; drugs that are generally accepted to increase the risk of Torsades de Pointes, include (but not limited to):\r\n* Quinidine, procainamide, disopyramide\r\n* Amiodarone, ibutilide, dofetilide, sotalol\r\n* Erythromycin, clarithromycin\r\n* Chlorpromazine, mesoridazine, thioridazine, pimozide\r\n* Cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine
Patients with a diagnosis of spinal cord ependymoma, myxopapillary ependymoma, subependymoma, ependymoblastoma, supratentorial ependymoma, or mixed glioma are NOT eligible for either Stratum
Additionally, patients treated in stage 1, cohort #3 must be EBV seropositive, given the inclusion of T cells derived from an EBV-specific subset in this group
Clinical and microbiologic relapse of C. difficile associated diarrhea after at least one course of adequate antibiotic therapy or refractory disease that does not respond to treatment\r\n* At least 10 days of vancomycin at least 125 mg four times daily (QID), or metronidazole 500 mg three times daily (TID)\r\n* C. difficile associated diarrhea is defined as:\r\n** >= 3 loose or watery stools per day for at least 2 consecutive days or >= 8 loose stools in 48 hours and\r\n** Positive Clostridium difficile polymerase chain reaction (PCR)
Serious cardiopulmonary comorbidities
Active fistula
Ileus
Gastroparesis
Presence of MRD (defined as < 5% blasts in the bone marrow by morphologic assessment and no clinically-apparent extramedullary disease but with quantifiably-measurable disease as assessed by either MFC or PCR) under any of the following circumstances:\r\n* MRD persistence >= 11 weeks after the start of initial therapy\r\n* MRD persistence >= 2 weeks after the start of salvage therapy, or \r\n* MRD reappearance at any time
Eligible for:\r\n* Cohort A: Robot-assisted radical cystectomy (RARC) as per the attending urologist\r\n* Cohort B: Robot-assisted radical Nephrectomy (RARN)/robot-assisted partial nephrectomy (RAPN) as per the attending urologist\r\n* Cohort C: RAPN as per the attending urologist
Subject has a known allergic/hypersensitivity to investigational components or excipients (doxorubicin, trehalose, monoclonal antibody therapy, penicillin class of antibiotics, gentamicin (or other aminoglycosides), or ciprofloxacin hydrochloride (or other quinolones)).
Patients must be vulnerable or frail by Balducci Criteria or the patient is refusing breast surgery; vulnerable patients are defined as those with dependence in some instrumental activities of daily living, well controlled co-morbidities, and early symptoms of geriatric syndrome; frail patients are defined as those with three or more co-morbidities, dependence in one or more activities of daily living, or a clinically significant geriatric syndrome; geriatric syndromes include: dementia, delirium, incontinence (fecal and/or urinary), osteoporosis or spontaneous fractures, polypharmacy, visual/hearing impairment, sarcopenia and neglect or abuse
Patients with a relapsed/refractory peripheral T cell lymphoma; patients must have received at least one prior standard cytotoxic regimen such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone (CHOP), or etoposide phosphate, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride (EPOCH) OR
Willing to comply with the treatment assignment:\r\n* Intent to proceed with high-dose cytarabine (HiDAC) consolidation for LAM VAF < 2.5%\r\n* Intent to proceed with either HiDAC consolidation or allogeneic stem cell transplantation, at the discretion of the treating physician, for LAM >= 2.5%
Caregiver capable of providing post-HCT care, who will be present once induction therapy with filgrastim, cladribine, cytarabine, mitoxantrone hydrochloride (GCLAM) begins
DLCOc < 40% or FEV1 < 50%
Burkitt cell or mixed lineage acute leukaemia
STUDY-SPECIFIC EXCLUSIONS:
Lung metastases will be unresectable due to anatomic location, distribution, or patients’ comorbidities, as determined by review of imaging by a faculty member in the Department of Thoracic & Cardiovascular Surgery
Have major abnormalities documented by ECHO with Doppler (for example, moderate or severe heart valve function defect including moderate or severe valve stenosis or regurgitation, left ventricular ejection fraction <50%, evaluation based on the institutional lower limit of normal, septal aneurysm or other heart aneurysm, any aneurysm of the major vessels or any condition that results in increased risk of aneurysm (eg, Marfan syndrome, patent foramen ovale [PFO]).
Have predisposing conditions that are consistent with development of aneurysms of the ascending aorta or aortic stress (for example, family history of aneurysms, Marfan syndrome, PFO, bicuspid aortic valve, evidence of damage to the large vessels of the heart documented by computerized tomography [CT] scan with contrast or magnetic resonance imaging [MRI]).
Hyponatremia (defined as serum sodium level < 130 mEq/L)
Adequate oral intake and nutritional status without current or likely need for enteral or parenteral feeding during chemoradiation or the preoperative period
Inadequate caloric or fluid intake whereby there is a current or likely future need for enteral or parenteral feeding during chemoradiation or the preoperative period
Loss of MMR following a first TKI discontinuation trial
Patient requiring anti-diabetic medications to manage hyperglycemia are eligible; adjustments of other anti-diabetic agents will be made with close monitoring of blood glucose
Known loss of complete cytogenetic response (CCyR) by marrow cytogenetic or blood fluorescence in situ hybridization (FISH) for breakpoint cluster region (BCR)- v-abl Abelson murine leukemia viral oncogene homolog 1 (ABL1)
Uncontrolled peripheral edema (2+ or more) of any etiology
Treatment-related mortality (TRM) score =< 13.1 as calculated with simplified model
Myeloproliferative neoplasms/myelofibrosis
Willing and qualified for active surveillance at Johns Hopkins or the University of Washington
The use of drugs known to lower the seizure threshold, including: atypical antipsychotics (e.g. clozapine, olanzapine, risperidone, ziprasidone), bupropion, lithium, meperidine, pethidine, phenothiazine antipsychotics (e.g. chlorpromazine, mesoridazine, thioridazine), and tricyclic antidepressants (e.g. amitriptyline, desipramine, doxepin, imipramine, maprotiline, mirtazapine)
invasive mediastinal staging requirement will be based on current American College of Chest Physicians (ACCP) lung cancer staging criteria and will be performed by any of the following tests, in appropriate patients, alone or in combination based on study site preference in accordance with ACCP guidelines - mediastinoscopy, mediastinotomy, VATS, endobronchial ultrasound, endoscopic ultrasound.
Histologic evidence of muscularis propria invasion
Patients with hydronephrosis that has not been addressed with a documented assessment (i.e. normal GFR, no intervention necessary) or an intervention such as placement of a stent or nephrostomy tube
Patients must not have any active infectious process.
Disease amenable to maximal surgical debulking via extended pleurectomy/decortication as determined by a surgeon specializing in mesothelioma
Have no extrathoracic disease by best surgical staging
Current evidence of corneal or retinal disorder/keratopathy including, but not limited to, bullous/band keratopathy, corneal abrasion, inflammation/ulceration, keratoconjuctivitis, confirmed by ophthalmologic examination
Study medication cannot be administered through gastric (G)-tube, unless additional information from the manufacturer becomes available in the future
Successful collection of T cells for JCAR014 manufacturing
Pathologically confirmed MPNST, with or without underlying diagnosis of neurofibromatosis type 1 (diagnostic criteria for neurofibromatosis type 1)
Current exposure to household contacts =< 15 months old or household contact with known immunodeficiency; NOTE: patient must avoid contact during documented viral shedding; participants with continuous viral shedding will be given recommendations for restricted activities to avoid contact with immunocompromised persons
Prior severe skin reaction (toxic epidermal necrosis) with immunomodulating agents
Requires left chest wall post-mastectomy radiation with or without bolus
Conventional chest wall radiation delivery dose of 50.4 Gy/ 28 fractions with or without a boost (boost will not be evaluated for endpoints)
PRIOR TO LYMPHODEPLETION: Patients on strong inhibitors of CYP1A2 (e.g., fluvoxamine, ciprofloxacin) as these may increase plasma concentrations of bendamustine, and decrease plasma concentrations of its metabolites
Patients with smoldering and lymphomatous ATL
Paget’s disease of the nipple
Patients for whom a plan meeting institutional quality criteria cannot be designed for SBRT treatment via the MRI-guided teletherapy unit, but for whom an SBRT plan meeting institutional quality criteria can be designed for a conventional linear accelerator
Using drugs known to lower or increase levels of DHEA
Disease-related exclusions
Medication related exclusions
Patient must have been evaluated by a University of California Los Angeles (UCLA) thoracic surgeon, and deemed medically and technically suitable for a pleurectomy/decortication procedure
Patients must have BOS as defined by the NIH consensus criteria (2014 updated criteria); to meet the criteria for BOS, all of the following must be present, in addition to at least one distinctive manifestation of cGVHD:\r\n* FEV1/vital capacity < 0.7 or the fifth percentile of predicted\r\n* FEV1 < 75% of predicted with >= 10% decline over less than 2 years; FEV1 should not correct to > 75% with albuterol, and the absolute decline for the corrected values should still remain at >= 10% from pre-transplant\r\n* Absence of infection in the respiratory tract\r\n* One of the 2 supporting features of BOS:\r\n** Evidence of air trapping by expiratory computed tomography (CT) or small airway thickening or bronchiectasis by high-resolution CT, or\r\n** Evidence of air trapping by PFTs: residual volume > 120% predicted or residual volume/total lung capacity elevated outside the 90% confidence interval\r\n* If a patient carries the diagnosis of cGVHD by virtue of organ involvement elsewhere, then only the first 3 criteria above are necessary
Patient with documented acute promyelocytic leukemia (PML) and/or PML- retinoic acid receptor (RAR) transcript
Documented platelet refractoriness
Skull defect such as missing bone or bullet fragments.
Myeloproliferative syndromes
If recent mold infection (e.g. aspergillus) must have minimum of 30 days of therapy and responsive disease and be cleared by infectious disease
Group II: KS (no prior therapy required):\r\n*Concurrent KSHV-associated multicentric Castleman disease (MCD)\r\n*KSHV Inflammatory Cytokine Syndrome (KICS), including those also meeting clinical criteria for KS immune reconstitution syndrome (KS IRIS)
Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation
intravaginal
transdermal
Progestogen-only hormonal contraception associated with inhibition of ovulation
injectable
implantable
Vasectomised partner
Current evidence of endocrine alterations of calcium/phosphate homeostasis, e.g., parathyroid disorders, history of parathyroidectomy, tumor lysis, tumoral calcinosis, etc
Current evidence of corneal or retinal disorder/keratopathy including, but not limited to, bullous/band keratopathy, corneal abrasion, inflammation/ulceration, and/or keratoconjunctivitis, confirmed by ophthalmologic examination
Acute renal failure due solely to readily reversible causes such as hypercalcemia, hyperuricemia, dehydration, hyperviscosity, or acute tubular necrosis from nephrotoxic drugs
Prior cerebrovascular event with persistent neurologic deficit
Kyphoplasty or vertebroplasty within 1 week prior to event 1
Albuminemia > 25g/L
Vulnerable population groups, i.e., prisoners, those lacking consent capacity, non-English speaking, illiterate, pregnant females
DONOR: Vulnerable population groups, i.e., prisoners, those lacking consent capacity, non-English speaking, illiterate, pregnant females
Total granulocytes of 1,000 per mcL or more
Patients with antibiotic allergies per se are not excluded; although the production of TIL for adoptive transfer includes antibiotics, extensive washing after harvest will minimize systemic exposure to antibiotics
All laboratory and imaging studies must be completed and satisfactory within 30 days of signing the consent document, with the exceptions of: negative serum pregnancy test for women of child-bearing potential that must be negative within 7 days of screening for the trial, pulmonary function tests and/or cardiac stress tests whose results are valid for 6 months if performed previously, unless there is an interval change in the patient’s clinical status determined by the Moffitt treating physician
Has active cytokine release syndrome from CTL019 infusion
Patients must be willing to consent for protocol #12-245 for IMPACT testing
May have had up to 24 months of ADT (testosterone suppression therapy) in the nonmetastatic setting and are at least 12 months removed from treatment
Must be willing to be treated with SBRT only at Johns Hopkins Hospital
Patients must be able to have fiducials placed; if not, the tumor must be posterior and adjacent to the aorta and treatment will only be permitted at the discretion of the principal investigator
Presence of duodenal or gastric invasion by the tumor as noted by esophagogastroduodenoscopy (EGD) at time of fiducial placement
Uncontrolled dysrhythmias or poorly controlled angina.
RECIPIENTS
RECIPIENTS:
Confirmed PDGFRA amplification in the tumor tissue at the time of diagnosis or time of recurrence. Central confirmation of PDGFRA amplification will be performed by FISH in CLIA certified lab (ProPath). Signal quantitation will be used to generate a PDGFRA/centromere 4 ratio. PDGFRA to Centromere 4 ratios will be interpreted as follows: 1.8 to 2.2, borderline for amplification; 2.2 to 5.0, low-level amplification; and greater than 5.0 or clustered signals that are too numerous to count would be considered highly amplified. Tumor samples with PDGFRA to Centromere 4 ratios of 2.2 or higher will be considered amplified and therefore eligible for this trial. For patients with local CLIA testing demonstrating PDGFRA amplification by Next Generation Sequencing (Foundation Medicine, CMS400), central testing will not be required.
Any prior to exposure to ruxolitinib
Diagnosis of colorectal carcinoma with intrahepatic metastases; limited extrahepatic metastasis is allowed as long as the overall metastatic burden is hepatic dominant
The predominant burden of disease lies in an arterial distribution which is accessible for transarterial chemoperfusion treatment
Willing to travel to a Legacy Health/Oregon Health & Science University (OHSU) facility if necessary
Multi-focal disease (unless pre-approved by principal investigator [PI])
If extrahepatic disease is present, it must be asymptomatic
Contraindications to angiography and selective visceral catheterization\r\n* Any bleeding diathesis or coagulopathy that is not correctable by usual therapy or hemostatic agents (e.g. closure device)\r\n* Severe allergy or intolerance to contrast agents, narcotics, or sedatives that cannot be managed medically
Any intervention for, or compromise of the ampulla of Vater
Planned resectional surgery for MPM (extrapleural pneumonectomy [EPP] or pleurectomy and decortication [P/D])
Receipt of sunitinib within 3 months of receiving tremelimumab
ENTRECTINIB EXCLUSION CRITERIA: History of other previous cancer that would interfere with the determination of safety or efficacy of entrectinib in melanoma
Patient has histologically confirmed (1) colorectal cancer, triple negative breast cancer, pancreatic cancer, non-small cell lung cancer, head and neck cancer, ovarian cancer, lymphoma, sarcoma, bladder cancer, or melanoma with defects in one or more of the following genes: ABL2, ACVR1B, APC, ASXL1, ATM, ATR, BLM, BRCA1, BRCA2, CDK12, CDKN1A, CDKN1B, CDKN2A, CHD4, CYLD, DICER1, DNMT3A, ERBB3, EZH2, FGFR2, FLT3, GATA3, HGF, KDM6A, KDR, KEAP1, KIT, KMT2D, KRAS, MAGI2, MAP3K1, MED12, MET, MSH-2, MSH-6, MYC, NA, NF1, NF2, NOTCH1, NOTCH2, NRAS, NSD1, PIK3C2B, PIK3CA, PIK3CB, PIK3R1, PTCH1, PTPN11, RB1, RUNX1, SETD2, SMARCA4, SOX9, STAG2, TAF1, TBX3, TET2, TP53, XPO1; (2) documented IDH1 mutated solid tumor (other than glioma); or (3) documented IDH1 mutated or MGMT promoter methylation positive glioblastoma multiforme (GBM) or anaplastic astrocytoma. Note: Genetic abnormalities must be documented by Foundation Medicine (or equivalent) genomic profile report.
Patient must have previously undergone standard chemoradiation- 59.4 Gy (1.8 Gy/fraction) or 60 Gy (2.0 Gy/fraction) with concurrent and adjuvant Temodar (temozolomide)
Willingness to fill out IPSS, SHIM, and EPIC quality of life forms
IPSS (American Urological Association [AUA]) score =< 15
Inability to have gold fiducial markers placed in the prostate, or fiducial markers already placed, that are not in accordance with the protocol
Any medication administered within 4 weeks prior to 1st dose of TAS3681 that is known to affect QT interval or arrhythmogenic
Anticipated lifespan greater than 12 weeks
2.
For women on estrogen based contraceptives, family history of venous thromboembolism (VTE) and/or risk factors predisposing for VTE and other medical conditions known to be associated with VTE.
Poor nutritional state (as determined by clinician)
Patients must have histologically confirmed diagnosis of World Health Organization (WHO) grade 4 malignant glioma and radiographic evidence of recurrence or disease progression (as defined by the Response Assessment in Neuro-Oncology [RANO] criteria as a greater than 25% increase in the largest bi-dimensional product of enhancement or a new enhancing lesion, or a significant increase in T2-weighted-Fluid-Attenuated Inversion Recovery [T2/FLAIR] abnormality without another co-morbid cause)
Classified as having insufficient tumor shrinkage by imaging (< 80% shrinkage after 4 cycles of anthracycline-based chemotherapy based upon diagnostic imaging)
Tracheo-esophageal (TE) fistula or direct invasion into the tracheo-bronchial mucosa; a bronchoscopy (biopsy and cytology should be performed) is required to exclude TE fistula or tracheo-bronchial involvement in patients with a tumor located at < 26 cm from the incisors
> 50% loss of vertebral body height
Bony retropulsion causing neurologic abnormality
Tumor infiltrating into large vessels or infiltrating into the proximal tracheobronchial network, visible on medical imaging; the investigator or radiologist must rule out tumors that conjoin, surround or extend into the immediate area of a large vessel (e.g.: pulmonary artery, superior vena cava)
Histological grade I, II, or III according to the modified Bloom Richardson scale
Children are excluded from this study
Pre- or perimenopausal status or menopausal status that cannot be accurately assessed (e.g. equivocal measurements of estradiol and FSH)
Platelets >= 50 x10^9 (SI units 10^9/L)
AZD1775 is an inhibitor of breast cancer resistance protein (BCRP); the use of statins including Atorvastatin which are substrates for BCRP are therefore prohibited and patients should be moved on to non-BCRP alternatives
An EKG recorded at screening showing evidence of cardiac ischemia (ST depression of >= 2 mm, measured from isoelectric line to the ST segment); if in any doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not CAD is present
Self-identify as African American/Black, Hispanic (any race), or White non-Hispanic
Does not self-identify as African American, Hispanic, or White (non-Hispanic)
Patients who have had only segmentectomies or wedge resections
Cohort 4: Pre-treated patients with cMET mutations regardless of cMET GCN, or
Cohort 6: Pre-treated patients with either cMET GCN ? 10 without cMET mutations or cMET mutations regardless of cMET GCN
In accordance with French Regulatory Authorities: Patients with French Social Security in compliance with the French law relating to biomedical research (Huriet Law 88-1138 and related decrees)
gBRCA1 and/or gBRCA2 mutations that are considered to be non detrimental (eg, \Variants of uncertain clinical significance\ or \Variant of unknown significance\ or \Variant, favour polymorphism\ or \benign polymorphism\ etc.)
Patients requiring ventilator support
Total mastectomy
AR (+), defined as >= 1% nuclear staining by IHC testing, the assessment of AR expression may have been performed any time in the past and is not limited to participation in Step 1
Hypersensitivity reaction to the active pharmaceutical ingredient or any of the capsule components, including Labrasol, butylated hydroxyanisole and butylated hydroxytoluene
Receiving erythroid stimulating agents (epoetin alfa [EPO]: Procrit, Aranesp)
For Cohort 1 (rhabdoid tumors only), the following test results must be available by local laboratory: morphology and immunophenotypic panel consistent with rhabdoid tumors, and loss of INI1 or SMARCA4 confirmed by IHC, or molecular confirmation of tumor bi-allelic INI1 or SMARCA4 loss or mutation when INI1 or SMARCA4 IHC is equivocal or unavailable
Radiotherapy (RT) (At least 14 days from last local site RT prior to first dose of tazemetostat/At least 21 days from stereostatic radiosurgery prior to first dose of tazemetostat/At least 12 weeks from craniospinal, ?50% radiation of pelvis, or total body irradiation prior to first dose of tazemetostat)
Any revascularization procedure, including the placement of a stent
Active pulmonary disease requiring medication to include multiple inhalers (>2 inhalers and one containing steroids)
Patients presenting for orthopaedic evaluation with a painful impending pathologic femur fracture or displaced pathologic femur fracture in the intertrochanteric, pertrochanteric, or subtrochanteric region of the proximal femur; the anatomic region of interest is defined by a line drawn from the base of the femoral neck to 5 cm below the base of the lesser trochanter or 2 diaphyseal shaft widths, whichever is greater
A large soft tissue mass or other disease involving an area outside of the defined pertrochanteric anatomic region; (patients excluded based on intra-operative findings will be replaced on the study)
Histologic diagnosis of AT/RT or MRT as documented by institutional pathologist with loss of INI1 or BRG1 expression in tumor cells confirmed by immunohistochemistry, or by molecular confirmation of tumor-specific biallelic SMARCB1 loss/mutation or SMARCA4 loss/mutation if INI1/BRG1 immunohistochemistry is not available; patients with synchronous extraneural AT/RT are eligible; for Stratum A participants, histologic confirmation of the diagnosis of AT/RT or MRT may be from the original diagnosis or at the time of recurrence/progression\r\n* Whereas testing of INI1 expression by immunohistochemistry is widely available, Clinical Laboratory Improvement Amendments (CLIA)-certified sequencing of SMARCB1 in tumor samples is only done in limited institutions; therefore, we expect that the vast majority of patients will have confirmation of their diagnoses by immunohistochemistry only; exceptional cases may require gene sequencing\r\n* Of note, occasional patients with histologic diagnosis suggestive of AT/RT or MRT may display immunohistochemical and/or molecular characteristics which are equivocal (e.g., patchy loss of INI1 expression by immunohistochemistry, proof of monoallelic loss of SMARCB1 without confirmation of second hit by sequencing of exons only); these cases may be confirmed unequivocally to represent AT/RT or MRT only by research studies (e.g., whole genome sequencing); therefore, we propose that such patients be candidates for the current study but their outcomes be described separately
Evidence of extensive intraperitoneal adhesions at the time of surgery, as determined by the operating surgeon which prohibits intraperitoneal therapy
Plan for superficial inguinal dissection alone or combined superficial inguinal and deep pelvic node dissection is acceptable
Hydroxyurea that is ongoing (hydroxyurea is permitted up to the first dose)
Complete preoperative colonoscopy demonstrating no synchronous colon cancer
Participants must be eligible to undergo laparoscopic or robotic low anterior resection with or without a temporary diverting stoma, based on multidisciplinary tumor board consensus
Tumors invading into the internal anal sphincter muscle based on DRE and pelvic MRI
Fecal incontinence at baseline
Caution should be exercised when administering paclitaxel (Taxol) concomitantly with medicines known to inhibit (e.g. ketoconazole and other imidazole antifungals, erythromycin, fluoxetine, gemfibrozil, cimetidine, ritonavir, saquinavir, indinavir and nelfinavir) OR induce (e.g. rifampicin, carbamazepine, phenytoin, efavirenz and nevirapine) either CYP2C8 or CYP3A4. Based on the in vitro data and SimCYP simulations, selumetinib is considered unlikely to perpetrate clinically significant drug-drug interaction via inhibition or induction of CYP enzymes
Patients with carcinosarcoma.
Willingness to take bupropion
Carbon monoxide (CO) test under 7 parts per million (ppm)
A stress cardiac test (stress thallium, stress multi-gated acquisition scan [MUGA], dobutamine echocardiogram or other stress test that will rule out cardiac ischemia) within 1 month of lymphodepletion
Patient’s carcinoma must express the mucin 16 (MUC16) ectodomain (ecto) antigen detectable by immunohistochemistry (IHC) analysis of banked (paraffin embedded) or freshly biopsied tumor
IHC evidence of MUC16^ecto expression will be performed according to the technique and 0-5 scoring system
ARM C COHORT 4: Patients who have had decompression of the biliary tree within the last 14 days, must have a stable bilirubin level as confirmed by two measurements that are within 5 to 7 days of each other; (the second measurement must be obtained within 7 days prior to registration); both the first and second measurement must be =< 2 X IULN; stability is defined as the second measurement being no more than one point higher than the first
Relapsed Ph+ ALL, with no prior exposure to dasatinib and without known ABL kinase mutations predicted to be resistant to dasatinib (e.g. L248R, L248V, Q252H, E255K, V299L, T315A, T315I, F317C, F317I, F317L, F317S, F317V)
Relapsed or refractory Ph-like ALL without prior exposure to dasatinib and with mutations or rearrangements of genes conferring sensitivity to dasatinib (ABL, CSF1R, PDGFRB) or ruxolitinib (CRLF2, JAK3, EPOR, TSLP)
Patients with dominant leukemic clone bearing documented bcr-abl mutations enabling bcr-abl TKI resistance at diagnosis
Mature B-cell (Burkitt’s) ALL
Patients with untreated MCL should be asymptomatic or minimally symptomatic from their MCL and without aggressive clinicopathological features that would otherwise warrant immediate intensive therapy; these will generally be patients who qualify for an initial period of “watch and wait” per clinical discretion
No histologic documentation of EOC
PHASE I STUDY ELIGIBILITY CRITERIA:\r\nPatients are allowed to have received prior PARP inhibitors (PARPi), and/or anti-angiogenesis therapy including but not limited to thalidomide, bevacizumab, sunitinib, sorafenib, or other anti-angiogenics; however, patients who were treated with both olaparib and cediranib, either in combination or sequentially are not eligible; for this study, BSI-201 (iniparib) is not considered as PARPi
Has not had a coma or long or multiple seizures within 7 days after a dose of DTP or Tdap unless a cause other than the vaccine was indicated
Subjects without placement of a biopsy clip at the diagnostic procedure who are unwilling to undergo clip placement
60 years of age or older or 50-59 with a low (0-17) oncotype score; oncotype is not required for women diagnosed with DCIS
Subjects without placement of a biopsy clip at the diagnostic procedure who are unwilling to undergo clip placement
Patients with microscopic hematuria OR biopsy proven BK nephritis and urine or blood polymerase chain reaction (PCR) positive for BK virus and/or JC viral encephalitis
Anastrozole defined by the Investigator based on institutional SOC, scientific evidence, expert medical judgment, or published literature
Ki67 score/proliferative index =< 20% or low to intermediate mitotic index
American Urological Association (AUA) =< 18 with or without medical management
Confirmation that insurance will cover SBRT through normal hospital authorization process
Contraindications to sildenafil including:\r\n* Known retinitis pigmentosa\r\n* History of priapism related to PDE5 inhibitors (eg, sildenafil, vardenafil, tadalafil)\r\n* Presence of nonmalignant hematologic disorders, such as sickle cell disease, that may increase the risk of priapism
BM cellularity < 30% and
< 20% for patients ? 60yrs.
FOR THE RANDOMIZED PORTION ONLY
FOR THE PILOT PORTION
Undergone molecular testing for integral biomarkers including immunohistochemical staining for vimentin
Scheduled for curative or palliative major cancer surgery; patient must be scheduled for at least one of the following procedures (i.e., Common Procedural Terminology [CPT codes]), and may be scheduled for more than one of these procedures within or across each of the following procedure types (e.g., glossectomy, pharyngectomy, etc.) or procedure families (e.g., head and neck surgery, thoracic surgery, etc.)\r\n* Head and neck surgery\r\n** Glossectomy (CPT codes 41135,41140,41145,41150,41153,41155)\r\n** Pharyngectomy (CPT codes 42842,42844,42845,42890,42892,42894)\r\n** Laryngectomy (CPT codes 31360,31365,31367, 31368, 31370, 31375, 31380, 31382, 31390, 31395)\r\n** Neck dissection (CPT codes 38720, 38724)\r\n* Thoracic Surgery\r\n** Esophagectomy (CPT codes 43101, 43107, 43108, 43112, 43113, 43116, 43117, 43118, 43121, 43122, 43123, 43124)\r\n** Lung resection (CPT codes 32440, 32442, 32445, 32480, 32482, 32484, 32486, 32488, 32491, 32503, 32504, 32505, 32506, 32507, 32663, 32666, 32667, 32668, 32669, 32670, 32671, 32672)\r\n* Upper gastrointestinal/hepatico-pancreatico-biliary surgery\r\n** Gastrectomy (CPT codes 43620, 43621, 43622, 43631, 43632, 43633, 43634)\r\n** Pancreatectomy (CPT codes 48120, 48140, 48145, 48146, 48148, 48150, 48152, 48153, 48154, 48155, 48999)\r\n** Hepatectomy (CPT codes 47120, 47122, 47125, 47130)\r\n* Colorectal surgery\r\n** Colectomy (CPT codes 44140, 44141, 44143, 44144, 44145, 44146, 44147, 44150, 44151, 44160, 44204, 44205, 44206, 44207, 44208, 44210)\r\n** Proctectomy (CPT codes 44155, 44156, 44157, 44158, 44211, 44212, 45110, 45111, 45112, 45113, 45114, 45116, 45119, 45120, 45121, 45123, 45126, 45130, 45135, 45160, 45395, 45397, 45402, 45550)\r\n* Gynecologic surgery\r\n** Hysterectomy/Myomectomy (CPT codes 58140, 58145, 58146, 58150, 58152, 58180, 58200, 58210, 58240, 58260, 58262, 58263, 58267, 58270, 58275, 58280, 58285, 58290, 58291, 58292, 58293, 58294, 58541, 58542, 58543, 58544, 58545, 58546, 58548, 58550, 58552, 58553, 58554, 58570, 58571, 58572, 58573, 58940, 58943, 58950, 58951, 58952, 58953, 58954, 58956)\r\n** Gynecologic reconstruction (CPT codes 57260, 57265, 57267, 57268, 57270, 57280, 57282, 57283)\r\n* Urologic Surgery\r\n** Prostatectomy (CPT codes 55801, 55810, 55812, 55815, 55821, 55831, 55840, 55842, 55845, 55866)\r\n** Nephrectomy (CPT codes 50220, 50225, 50230, 50234, 50236, 50240, 50543, 50545, 50546, 50548)\r\n** Cystectomy (CPT codes 51550, 51555, 51565, 51570, 51575, 51580, 51585, 51590, 51595, 51596, 51597)\r\n* Soft tissue/plastic surgery\r\n** Breast reconstruction (CPT codes 19324, 19325, 19340, 19342, 19357, 19361, 19364, 19366, 19367, 19368, 19369)\r\n** Flap reconstruction (CPT codes 15731, 15732, 15734, 15736, 15738, 15740, 15750, 15756, 15757, 15758)
ADDITIONAL CRITERIA FOR STUDY CONTINUATION: Major active medical or psychosocial problems that could be exacerbated by this treatment
Patients may not be receiving any medication that may markedly affect renal function (e.g., vancomycin, amphotericin, pentamidine)
AT THE TIME OF INFUSION: Intracranial catheter (such as Rickham or Ommaya) in place
MRI MONITORING SUB-STUDY: Engaged in occupations or activities which may cause accidental lodging of ferromagnetic materials, or have imbedded metal fragments from military activities
MRI MONITORING SUB-STUDY: Received orthodontic work involving ferromagnetic materials
Clinical assessment score will be obtained, at baseline\r\n* Visual assessment (VA) in affected eye of at least 20/200 - 0/1\r\n* Ocular motility intact - 0/1\r\n* No diplopia - 0/1\r\n* Binocularity (fusion) +/- prism - 0/1\r\n* Normal tear lake, no complaint of persistent tearing - 0/1\r\n* Intact lacrimal system by probing/irrigation (both canaliculi to nasolacrimal duct [NLD]) - 0/1\r\n* Patient assessment of visual function on the affected side (good, fair, poor) - 0/1/2\r\n* Score maximum - 8
Medical oncology screening evaluation performed to assess medical indication/contra-indication to vismodegib treatment
Principal investigator (PI) to review the exam findings, photos and imaging study and determine whether the patient meets inclusion criteria in the study, based on BCCA size, location of tumor, and clinical assessment score\r\n* Orbital invasion or impending invasion by BCCA\r\n* Medial canthal BCCA within 7 mm of lacrimal apparatus
Prior to enrollment, the CA125 should have been elevated to at least double the level seen at the nadir value following the first complete response and measurable intraperitoneal disease that can be identified radiologically and accessed by laparoscopy/laparotomy for a biopsy and peritoneal catheter placement
Patients with a recognized immunodeficiency disease including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; patients who have acquired, hereditary, or congenital immunodeficiencies
One or more evaluable or measurable lesions that have progressed based on RECIST 1.1, within 12 months of 131 iodine therapy, despite demonstration of radioiodine avidity at the time of that treatment by pre- or post-treatment scanning. These participants must not be eligible for possible curative surgery; or
Subjects with locally advanced, unresectable primary tumors will not be eligible\r\n* This includes any of the following:\r\n** Abutment of the SMA >= 180 degrees\r\n** Occlusion of the SMV or PV with insufficient normal vein above and below with which to perform venous reconstruction\r\n** Involvement of the hepatic artery with insufficient artery proximal and distal to perform reconstruction
Subjects with plastic biliary stents will be excluded; metal biliary stents are allowed and will not be excluded
Subjects with a strong likelihood of non-adherence such as difficulties in adhering to follow-up schedule due to geographic distance from the Siteman Cancer Center should not knowingly be registered
Hb ? 9 g/dL (independent of transfusions or erythropoiesis-stimulating agents [ESA]).
Note: Patients positive for hepatitis B and C will be evaluated on a case by case basis
Have had complete (CC-0 or CC-1) CRS with HIPEC open or minimally invasive (laparoscopic or robotic)
Able to perform 6 minute walk test
Recent documented myocarditis within 2 months of consent
Mechanical or bioprosthetic heart valve
Cardiogenic shock
ITP that has persisted for ? 3 months. ITP must be diagnosed in accordance The American Society of Hematology 2011 Evidence-based Practice Guideline for Immune Thrombocytopenia (Neunert et al. 2011) or the International Consensus Report on The Investigation and Management of Primary Immune Thrombocytopenia (Provan et al. 2010), as locally applicable.
FLT3-ITD or FLT3-D835 positive disease at any time during disease course.
Chronic daily usage of antihistamine without an acceptable alternative non-antihistamine medication
Current or previous treatment with an 3-hydroxy-3-methyl-glutaryl-coenzyme A reductase (HMG CoA) reductase inhibitor (any statin)
Category I drugs that are generally accepted to have a risk of causing torsades de pointes including: (patients must discontinue drug at least 7 days prior to starting dasatinib)\r\n* Quinidine, procainamide, disopyramide\r\n* Amiodarone, sotalol, ibutilide, dofetilide\r\n* Chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide\r\n* Cisapride, bepridil, droperidol, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, sparfloxacin, lidoflazine
A documentation of diagnosis of hemophagocytic lymphocytosis, either newly diagnosed or relapsed/refractory by the treating physician and the principal investigator (PI) in the patients chart; it must be noted that no diagnostic criteria have been established for diagnosis of HLH in adult patients as this was a hitherto poorly identified and considered to be a very rare disease in adults; adult HLH seems to occur more frequently post malignancy and has a more fulminant course than pediatric HLH; in the absence of standard diagnostic guidelines if the patient's symptoms are highly suspicious for HLH and after an adequate work-up to rule out alternate potential alternate etiologies is performed we will treat the patient for HLH as missing the diagnosis is associated with high mortality; these patients will be discussed with the PI (Dr. Daver) prior to enrollment in all such cases
Patients must have evidence of MIBG avid disease as determined by diagnostic MIBG scan obtained within 4 weeks of MIBG infusion; at least one MIBG avid target lesion that can be evaluated for response must be present at study entry; computed tomography (CT)/magnetic resonance imaging (MRI) evaluation of all sites of disease must be completed within 4 weeks of MIBG infusion
Platelets >= 100 K/cumm (must be within 7 days of MLA)
Evaluable myelofibrosis by IWG-MRT criteria including one or more of the following:\r\n* Spleen >= 5 cm below the left costal margin\r\n* MPN-SAF total symptom score (TSS) > 10 at baseline\r\n* Hemoglobin < 10 g/dL
Confirmed diagnosis of myelofibrosis (primary myelofibrosis or myelofibrosis secondary to essential thrombocythemia or polycythemia vera) by World Health Organization (WHO) diagnostic criteria (3 major and 2 minor criteria: major criteria: megakaryocyte proliferation and atypia with either reticulin and/or collagen fibrosis, not meeting criteria for chronic myelogenous leukemia [CML], polycythemia vera [PV], myelodysplastic syndrome [MDS], or other myeloid neoplasm, JAK2V617F or other clonal marker or no evidence of reactive marrow fibrosis; minor criteria: leukoerythroblastosis, increased lactate dehydrogenase [LDH], anemia, palpable splenomegaly)
Patients with intolerance to compounds similar to pegylated interferon alpha-2b
Absence of any autoimmune syndrome typically associated with thymomas but not thymic carcinomas (myasthenia gravis, pure red cell aplasia, etc.)
Subjects with a strong likelihood of non-adherence such as difficulties in adhering to follow-up schedule due to geographic distance from the Siteman Cancer Center should not knowingly be registered
Individuals in whom a skinfold measurement of the cutaneous and subcutaneous tissue for eligible injection sites (left and right medial deltoid region) exceeds 40 mm
Individuals in whom the ability to observe possible local reactions at the eligible injection sites (deltoid region) is, in the opinion of the investigator, unacceptably obscured due to a physical condition or permanent body art
Received systemic therapy with radionuclides (e.g., strontium-89, samarium-153, rhenium-186, or rhenium-188, or radium Ra 223 dichloride) for the treatment of bony metastases
Fecal incontinence
American Urological Association Symptom Index (AUA SI) =< 15
AUA SI > 15
Patients actively receiving insulin are excluded unless approved by the investigational new drug (IND) medical monitor, IND sponsor, and the study principal investigator (PI)
Patients requiring daily finger-stick blood glucose measurements unless approved by the IND medical monitor, IND sponsor, and the study PI
Patients who are on warfarin and cannot have a drug substitution or who decline the drug substitution
Patients who are on the following drugs and cannot have a drug substitution: flecainide, methadone, amphetamines, quinidine, and chlorpropamide; high dose ascorbic acid may affect urine acidification and, as a result, may affect clearance rates of these drugs
Any cytogenetic abnormality in the bone marrow that is known to be associated with or predictive of myelodysplasia is excluded; this includes, but is not limited to, del(5), del(7), del(11)
INCLUSION CRITERIA FOR ADDITIONAL PTCy-MILs INFUSION AT RELAPSE: Confirmation of active relapse involving the bone marrow of a hematologic malignancy >= 6 months after alloHCT employing PTCy as GVHD prophylaxis and more than 90 days after PTCy-MILs infusion
EXCLUSION CRITERIA FOR ADDITIONAL PTCy-MILs INFUSION AT RELAPSE: More than 2 years have elapsed since the patient’s initial PTCy-MILs infusion
EXCLUSION CRITERIA FOR ADDITIONAL PTCy-MILs INFUSION AT RELAPSE: Most recent alloHCT performed did not utilize PTCy GVHD prophylaxis
EXCLUSION CRITERIA FOR ADDITIONAL PTCy-MILs INFUSION AT RELAPSE: The use of immunosuppression for grade II-IV acute GVHD within 28 days prior to the infusion of PTCy-MILs
Patients with any tumor obstructing the distal bile duct and causing an indwelling biliary SEMS occlusion
Patients with jaundice or clinical cholangitis, with new elevation of alkaline phosphatase, total bilirubin, and imaging findings supportive of stent occlusion (loss of stent patency, debris within stent, loss of or excessive pneumobilia)
Have altered gastro-duodenal or hepatobiliary anatomy such that endoscopic retrograde cholangiopancreatogram (ERCP) is felt to be unacceptably technically difficult or unsafe
Have additional sites of biliary strictures (intrahepatic/hilar) such that ERCP stenting is felt to be unlikely to provide adequate clinical benefit
Have biliary strictures not technically amenable to endoscopic therapy
Patients on antipsychotic medication
EUS evidence of vessel interfering with path of fiducial marker
Evaluation by a surgical oncologist, radiation oncologist, and medical oncologist =< 28 days prior to registration
Either resectable or borderline resectable as determined on staging imaging (as defined by National Comprehensive Cancer Network [NCCN])
Patients with T315I mutations will be excluded (this criteria is not applicable for the frontline Ph+ ALL or CML-LBC cohort)
Normal serum sodium level without need for supplementation
ELIGIBILITY CRITERIA FOR T-CELL PRODUCT INFUSION: Patient has not received immunotherapy (for example- murine, chimeric or humanized monoclonal antibodies), T cell growth factors (such as IL-2, IL-7 or IL-15), interferons, vaccines, and other cellular products), pentoxifylline within the 7 days prior to the infusion of the T cell product
RETREATMENT WITH MODIFIED T CELLS: Normal serum creatinine based on age/gender
RETREATMENT WITH MODIFIED T CELLS: Normal serum sodium level without need for supplementation
We will carefully consider the inclusion of patients with severe artifacts in 4D CT images, which deteriorate the accuracy of ventilation computation
Breakpoint cluster region-Abelson positive (BCR-ABL +) patients will be excluded from the study
Inability to perform y90 TARE due to: (1) inability to catheterize the hepatic artery, (2) portal vein thrombosis/occlusion without the ability to perform selective infusion, (3) technetium Tc 99m-labeled macroaggregated albumin (Tc-99m MAA) hepatic artery perfusion scintigraphy shows unfavorable shunt fraction between the liver and the pulmonary parenchyma as determined by the interventional radiologist, or (4) other contraindication to TARE identified by interventional radiologist
Patients with circumferential epidural disease
Patients with paraspinal extension of disease with visceral involvement, exclusive of patients with cauda equina and sacral disease extension
Subjects who have received at least one vaccine under protocol University of Pennsylvania Cancer Center (UPCC)-19809 or UPCC-29810
Subjects who are positive for serum anti-Yo (cerebellar degeneration-related protein 2 [cdr2]) antibodies are not eligible; (Yo antibody does not need to be repeated if performed in the past)
Hemodynamic instability requiring continuous infusions of inotropes or vasopressors
Smoking 5 or more cigarettes, little cigars and/or cigarillos per day, on average, within the 2 months preceding the screening visit and expired carbon monoxide (CO) greater than or equal to 6 parts per million (ppm) (if less than or equal to 5, then NicAlert Strip > 2)
Individuals rated as moderate (9-16) to high (17 or greater) on suicidality as assessed by Module B of the MINI
Positive toxicology screen for any of the following drugs: cocaine, opiates, methadone, benzodiazepines, barbiturates, amphetamines, methamphetamines, phencyclidine (PCP), or tetrahydrocannabinol (THC); a. participants with valid prescriptions for opiates, benzodiazepines, barbiturates, amphetamines or methadone will not be excluded; b. participants failing the toxicology screen will be allowed to re-screen once; if they test positive again, they will not be allowed to return
Extensive disease, disease location, and/or co-morbid condition that the PI or designee considers unsafe for surgical intervention of NK cell infusion
Willingness to take everolimus orally and maintain a pill diary
DONOR: Selection of two CB units is allowed to provide sufficient cell dose (see below for algorithm to determine single versus double unit transplant); when multiple units are selected, the following rules apply:\r\n* The CB unit with the least HLA disparity (with the patient) will be selected first (i.e., selection priority is 6/6 match > 5/6 match > 4/6 match); additional CB units then may be selected to achieve the required cell dose, as outlined below; if a second unit is required, this unit will be the unit that most closely HLA matches the patient and meets minimum size criteria outlined below of at least 1.5 x 10^7 total nucleated cells (TNC)/kg (i.e. a smaller, more closely matched unit will be selected over a larger, less well matched unit as long as minimum criteria are met)\r\n* If two CB units are used:\r\n** The total cell dose of the combined units must be at least 3.0 x 10^7 TNC per kilogram recipient weight\r\n** Each CB unit MUST contain at least 1.5 x 10^7 TNC per kilogram recipient weight\r\n* Algorithm for determining single versus double unit cord blood transplant:\r\n** Match grade 6/6: TNC dose >= 2.5 x 10^7/kg\r\n** Match grade 5/6, 4/6: TNC dose >= 4.0 (+/- 0.5) x 10^7/kg
DONOR: General comments:\r\n* Units will be selected first based on the TNC dose and HLA matching\r\n* Cluster of differentiation (CD)34+ cell dose will not be used for unit selection unless 2 units of equal HLA-match grade and similar TNC dose (+/- 0.5 x 10^7 TNC/kg) are available; in this case, the unit with the larger CD34+ cell dose (if data available) should be selected\r\n* A CB unit that is 5/6 mismatched but homozygous at the locus of mismatch should be chosen over a 5/6 unit with bidirectional mismatch even if the latter unit is larger (has more cells); this also applies to 4/6 units; this is only applicable to choosing units within a given match grade\r\n* Other factors to be considered: \r\n** Within the same HLA match grade, matching at DR takes preference\r\n** Cord blood banks located in the United States are preferred\r\n* Up to 5% of the cord blood product(s), when ready for infusion, may be withheld for research purposes as long as thresholds for infused TNC dose are met; these products will be used to conduct studies involving the kinetics of engraftment and immunobiology of double cord transplantation
DONOR: Non-inherited maternal antigen (NIMA), inhibition of platelet aggregation (IPA), and natural killer cell (NK) reactivity will not be included in selection criteria
Masses located close to the hilar vessels or at locations that cannot be accessed with the HIFU probe
Abdominal obesity that would, in the assessment of the principal investigator (PI), make the HIFU ablation difficult
Pre-existing tumor-infiltrating lymphocytes in an archived tumor specimen or fresh biopsy, defined as an average of >= 4 TILs/high power field (HPF) in 5 consecutive HPFs, within the area with the highest TILs at low power; or, DNA mismatch repair deficiency, determined by immunohistochemistry or polymerase chain reaction per Memorial Sloan-Kettering Cancer Center (MSKCC) institutional standard practice; DNA mismatch repair deficient tumors may be TIL positive or negative
Produce an expired carbon monoxide (CO) level greater than or equal to 6 parts per million (ppm) or a NicAlert reading of > 2
Report uncorrected vision problems
Unwilling to alter or remove hairstyle, hair extensions, or wig during the clinic visits to allow for correct electroencephalography (EEG) sensor placement
Have STEC-HUS
Have a positive direct Coombs test
Satisfactory (adequate) colposcopy
Lives within 100 miles of the University of Alabama at Birmingham
Cervical lesion incompletely visualized (e.g., extending into the endocervical canal)
Endocervical curettage positive for high-grade cervical intraepithelial neoplasia
Granulocytes >= 1,500/mcL
Patients who are unable to perform the breath hold scan
Tumor proliferation-related Ki-67 antigen (Ki67) value is reported as “low” after 14 days of endocrine therapy
Subjects with a strong likelihood of non-adherence such as difficulties in adhering to follow-up schedule due to geographic distance from the Siteman Cancer Center should not knowingly be registered
Individuals in whom a skinfold measurement of the cutaneous and subcutaneous tissue for the eligible injection sites (left and right medial deltoid region) exceeds 40 mm
Individuals in whom the ability to observe possible local reactions at the eligible injection sites (deltoid region) is, in the opinion of the investigator, unacceptably obscured due to a physical condition or permanent body art
T3/4 or N3
T1N0 disease
Anion gap > 16 meq/L or arterial blood pH < 7.30.
Patients receiving neo-adjuvant chemotherapy whose disease has progressed following at least 3 cycles, defined by at least one of the following: clinical deterioration (new or worsening of existing ascites, carcinomatous ileus, malignant bowel obstruction, declining performance status), new lesion(s) or increase in maximal diameter of > 20% of the two largest target lesions, rising CA-125 (an increase of at least 10% of baseline value that increases over 3 values obtained every 21 days)
No appropriate caregivers identified
Metastases detected below the tentorium or beyond the cranial vault
Homozygous negative for the UDP glucuronosyltransferase 1 family, polypeptide A1 (UGT 1A1)*28 allele
One prior single fraction radiosurgical procedure within the treatment field is acceptable if V12 < 5 cc (V12 is the volume of normal brain [outside gross tumor volume (GTV)] receiving 12 or more Gy); additional radiosurgical procedures outside of the treatment area are acceptable
Mastectomy intended
Paget’s disease of the nipple
Prior therapy with fenretinide, or fenretinide + ketoconazole, if DLT's were experienced
Patients on other essential medications for which an interaction with ketoconazole can be expected and for which dose reductions to other essential medications cannot be made in a manner adequate to ensure patient safety
Having a tattoo on the back that is too large to permit PVB injections (as determined by the provider performing the procedure)
Pathologic N2a, N2b, or N2c disease
Metastatic or locally advanced refractory/recurrent cancer that expresses MAGE-A3 as assessed by one of the following methods: reverse transcriptase (RT)-polymerase chain reaction (PCR) on tumor tissue defined as 30,000 copies of MAGE-A3 per 10^6 glyceraldehyde-3-phosphate dehydrogenase (GAPDH) copies, or by immunohistochemistry of resected tissue defined as 10% or greater of tumor cells being 2-3+ for MAGE-A3, or serum antibody reactive with MAGE-A3; metastatic cancer diagnosis will be confirmed by the Laboratory of Pathology at the National Cancer Institute (NCI)
Note: exceptions may be made at the discretion of the principal investigator (PI)/study team
The last dose of lymphotoxic chemotherapeutic agents (e.g. cyclophosphamide, ifosofamide, bendamustine, etc) must be at least 2 weeks before lymphodepletion
No clinical evidence of uncontrolled active infectious process
STUDY-SPECIFIC EXCLUSIONS:
No clinical evidence of uncontrolled active infectious process
Any contra-indication to angiography
Able to take daily aspirin (325 mg) for the duration of INCB7839 treatment and 1 week after the last dose to reduce the risk of thrombosis (not applicable if on other anti-coagulant therapy at time of study registration)
Chronic neurologic condition which affects voice or swallow (for instance, multiple sclerosis or Parkinson disease)
The patient is unable to sustain treatment with antiviral drugs due to drug associated toxicities (e.g. myelosuppression [ANC< 1000?l/ml without GCSF support] or nephrotoxicity [corrected creatinine clearance ? 60 ml/min/1.73 m^2 or serum creatinine > 2 mg/dl]) CMV infections are life threatening, and may involve multiple organ systems such as the lungs, liver, gastrointestinal tract, hematopoietic and central nervous systems. Antiviral drugs used for treatment may also compromise renal and hematopoietic function. Therefore, dysfunctions of these organs will not affect eligibility for this protocol.
Patients who are moribund
Negative purified protein derivative (PPD) test
Subjects on cisapride, oral midazolam, nisoldipine, felodipine, pimozide, quinidine, dofetilide, triazolam, methadone, levacetylmethadol (levomethadyl), lovastatin, simvastatin, dihydroergotamine, ergometrine (ergonovine), ergotamine and methylergometrine (methylergonovine), cisapride, pimozide, methadone, levacetylmethadol (levomethadyl), quinidine
Prior radiosurgery
Baseline Chemistry
Metastatic or locally advanced refractory/recurrent cancer that expresses MAGE-A3 as assessed by one of the following methods: reverse transcriptase (RT)-polymerase chain reaction (PCR) on tumor tissue defined as 30,000 copies of MAGE-A3 per 10^6 glyceraldehyde 3-phosphate dehydrogenase (GAPDH) copies, or by immunohistochemistry of resected tissue defined as 10% or greater of tumor cells being 2-3+ for MAGE-A3, or serum antibody reactive with MAGE-A3; metastatic cancer diagnosis will be confirmed by the Laboratory of Pathology at the National Cancer Institute (NCI)
EBV: For treatment of persistent EBV infection despite standard therapy; for EBV infection, standard therapy is defined as rituximab given at 375 mg/m^2 in patients for 1-4 doses with a cluster of differentiation (CD)20+ tumor\r\n* EBV infection: defined as\r\n** Biopsy proven lymphoma with EBV genomes detected in tumor cells by immunocytochemistry or in situ PCR\r\n** Or clinical or imaging findings consistent with EBV lymphoma and/or elevated EBV viral load in peripheral blood\r\n* Failure of therapy is defined as\r\n** Increase or less than 50% response at sites of disease for EBV lymphoma OR\r\n** Increase or a fall of less than 50% in EBV viral load in peripheral blood or any site of disease after 1st dose of rituximab
BK virus: Treatment of persistent BK virus infection or BK virus disease despite antiviral treatment with cidofovir or leflunomide; no clear standard treatment is defined; cidofovir has been administered in low doses as well as high doses to HSCT patients with BK infections but no randomized trials are available proving its clinical efficacy; in small trials leflunomide had activity against BK virus, therefore we will consider this agent an acceptable alternative to cidofovir, given the absence of a clear first line option\r\n* BK virus infection is defined as the presence of BK virus positivity as detected by PCR or culture in one site such as blood or urine\r\n* BK virus disease is defined as the presence of BK virus detectable by culture or PCR in blood or urine or other body fluids and symptoms of disease including, but not limited to persistent microscopic or macroscopic hematuria or detectable BK virus in more than one site\r\n* Failure of therapy is defined as a rise or a fall of less than 50% in viral load in peripheral blood or any site of disease (as measured by PCR or any other quantitative assay) or worsening hematuria after 7 days of antiviral therapy
HHV6: Treatment of persistent HHV6 infection or disease despite antiviral treatment with ganciclovir, cidofovir and foscarnet; no clear standard treatment is defined; ganciclovir, cidofovir and foscarnet all have variable in vitro activity against HHV-6, and may have a role in treating HHV-6-associated disease – therefore antiviral treatment with one or more of these agents will we acceptable initial therapy\r\n* HHV6 virus infection is defined as the presence of elevated HHV-6 levels as detected by PCR or positive culture in one site such as cerebrospinal fluid (CSF) or blood\r\n* HHV6 disease is defined as defined as the presence of HHV6 detectable by culture or PCR in one or more sites such as blood or CSF and symptoms of disease including symptoms of HHV6 encephalitis OR detectable HHV6 by PCR or culture in more than one site\r\n* Failure of therapy is defined as a rise or a fall of less than 50% in viral load in peripheral blood or any site of disease (as measured by PCR or any other quantitative assay) after 7 days of antiviral therapy
JC virus: Treatment of progressive or persistent JC virus infection or disease without suitable alternative treatment option; pepmixes specific for antigens on adenovirus, EBV, CMV, HHV6 and BK virus are used to generate multivirus-specific VSTs; no pepmix specific for the rare JC virus is used for generation of these cytotoxic T lymphocytes (CTLs), however given the high homology (> 90%) between JC and BK and the fact that BK virus-specific T cells targeting polyomavirus capsid protein (VP1) and large T (as targeted in multivirus VSTs) have been administered to treat JCV-progressive multifocal leukoencephalopathy (PML), resulting in viral clearance from the cerebrospinal fluid it is likely that VSTs are efficacious against JC virus; given the current lack of treatment options for JC virus infection or reactivation after HSCT and the risk of progression to PML, which is almost uniformly fatal, and the apparent activity of BK virus-directed T cells against JC virus infected cells, this trial proposes including patients with progressive or persistent JC virus on this study, unless a suitable alternative therapy is available\r\n* JC virus infection is defined as the presence of elevated JC virus levels as detected by PCR or positive culture in one site such as CSF or blood\r\n* JC virus disease is defined as defined as the presence of JC virus detectable by culture or PCR in one or more sites such as blood or CSF and symptoms of disease including symptoms of PML OR detectable JC virus by PCR or culture in more than one site
Available multivirus-specific VSTs
Patients are in CR/VGPR or have primary refractory NB in BM - i.e., NB resistant to standard therapy, as evidenced by persistence of NB in the BM by histology or metaiodobenzylguanidine (MIBG) scan, but all other findings in scans show VGPR
Requires urinary catheterization for voiding due to obstruction secondary to prostatic enlargement thought to be due to prostate cancer or benign prostatic hyperplasia
No prior attempt at mobilizing PBSC
Patients must be at least 4 weeks from last cytotoxic chemotherapy (including alkylating, anthracyclines, epipodophyllotoxins, and platinum drugs), or immunomodulatory drugs (including lenalidomide or pomalidomide, or related derivatives) at time of treatment on this protocol
Diagnosis of intrahepatic malignancy including but not limited to HCC; the histopathology confirmation criterion may be waived in patients with a radiographically identifiable liver mass, known laboratory or clinical risk factors for cancer or elevated tumor markers such as alpha-fetoprotein (AFP) and clinical findings
Any contraindications to angiography and hepatic artery catheterization such as:\r\n* History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine that cannot be corrected or premedicated\r\n* Bleeding diathesis, not correctable by usual forms of therapy\r\n* Severe peripheral vascular disease that would preclude catheterization
Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs in a single treatment
Willing to provide all biologic specimens as required by the protocol
Exposure to household contacts =< 15 months old or household contact with known immunodeficiency
Tumor involvement which would require ventricular, brainstem, basal ganglia, or posterior fossa inoculation or would require access through a ventricle in order to deliver treatment
Concurrent therapy with any drug active against simplexvirus (HSV) (acyclovir, valacyclovir, penciclovir, famcyclovir, gancyclovir, foscarnet, cidofovir)
Fractional shortening (FS) > 27%
The patient who has not previously received hyperthermic intraperitoneal chemotherapy must have histopathologically or cytologically confirmed cancer from peritoneal mesothelioma, pseudomyxoma, or gastrointestinal malignancies (excluding pancreatic and hepatobiliary) with known synchronous or metachronous disease dissemination limited to the peritoneal surfaces
Sickle cell disease - patients with sickle cell disease at high risk for disease related morbidity or mortality, defined by having irreversible end-organ damage (A, B, C, D, or E) or potentially reversible complication(s) not ameliorated by hydroxyurea (F):\r\n* A. Stroke defined as a clinically significant neurologic event that is accompanied by an infarct on cerebral magnetic resonance imaging (MRI) or an abnormal trans-cranial Doppler examination (>= 200 m/s); or\r\n* B. Sickle cell related renal insufficiency defined by a creatinine level >= 1.5 times the upper limit of normal and kidney biopsy consistent with sickle cell nephropathy or nephrotic syndrome or creatinine clearance < 50 mL/min or requiring peritoneal or hemodialysis; or\r\n* C. Pulmonary hypertension as defined by tricuspid regurgitant jet velocity (TRV) of >= 2.5 m/s at least 3 weeks after a vaso-occlusive crisis; or\r\n* D. Recurrent tricorporal priapism defined as at least two episodes of an erection lasting >= 4 hours involving the corpora cavernosa and corpus spongiosa; or\r\n* E. Sickle hepatopathy defined as either ferritin > 1000 mcg/L or direct bilirubin > 0.4 mg/dL at baseline; or
Thalassemia - patients with thalassemia who have grade 2 or 3 iron overload, determined by the presence of 2 or more of the following:\r\n* Portal fibrosis by liver biopsy \r\n* Inadequate chelation history (defined as failure to maintain adequate compliance with chelation with desferroxamine initiated within 18 months of the first transfusion and administered subcutaneously for 8-10 hours at least 5 days each week)\r\n* Hepatomegaly of greater than 2 cm below the costochondral margin
Major ABO mismatch
Isolated extra-medullary disease relapse
Results of ATRX and/or 1p/19q chromosomal status: if ATRX is lost, 1p/19q status is not required; if ATRX is intact, 1p/19q chromosomal status must be available to permit treatment selection
Results of pRAS40 testing
Multi-focal disease
Prior TACE
Patients with worsening depression that has not been addressed clinically will be excluded from this study
Radiologic workup must demonstrate that the thoracic disease is confined to only one hemi-thoracic cavity and must be deemed potentially resectable by the surgical team
The extrathoracic disease must be controlled
Positive test results for human T-lymphotropic 1 (HTLV 1) virus; HTLV testing is required in patients from endemic countries (Japan, countries in the Caribbean basin, South America, Central America, Sub Saharan Africa, and Melanesia)
Cancer antigen (CA) 19-9 level (to establish baseline)
No appropriate caregivers identified
Patients with porphyria are ineligible
Patients with a history of neurofibromatosis (NF) may have other stable central nervous system (CNS) tumors, such as schwannoma, acoustic neuroma, or ependymoma only if those lesions have been stable for the past 6 months
Lymphocytes >= 500/mcL
Histologically documented uterine leiomyosarcoma with no visible residual disease
A stress cardiac test (stress thallium, stress multi gated acquisition scan [MUGA], dobutamine echocardiogram or other stress test that will rule out cardiac ischemia) within 6 months of lymphodepletion (Turnstile II)
Pedunculated polyps (as defined by Paris Classification type Ip or Isp)
Poor bowel preparation
Patients with any number of recurrences are allowed
History of central nervous system (CNS) radiotherapy: radiation of 60 gray (Gy) in 30 fractions, 59.4 Gy in 1.8 Gy fractions, 75 Gy in 30 fractions or equivalent or lower doses
Known sensitivity or allergy to conductive hydrogels (like the gel used on electrocardiogram [ECG] stickers or TENS [transcutaneous electrical nerve stimulation] electrodes)
Uncontrolled narrow-angle glaucoma
History of Grade 3 or higher blood transfusion incident according to US Biovigilance Network which refers to any transfusion followed by a major intervention (vasopressors, intubation, transfer to intensive care) to prevent death.
Presenting with anti-erythrocyte antibodies leading to the unavailability of phenotype compatible red blood cells.
Infratentorial disease
Evidence of recent hemorrhage on screening MRI of the brain with the following exceptions: presence of hemosiderin; resolving hemorrhagic changes related to surgery; presence of punctate hemorrhage in the tumor
RANDOMIZED PHASE II (ARMS K AND L): Patients may not have received other prior activating immunotherapies (i.e. checkpoint inhibitor therapies); for the purposes of this study monoclonal antibodies and antibody drug conjugates are not considered to be activating immunotherapies and there are no additional time restrictions on prior exposure to these agents (except prior brentuximab vedotin)
At least one (usually up to 3) gold fiducial placed in or around tumor, can be performed on the same day-after signing research informed consent
No irreversible coagulopathies
Irreversible coagulopathies that preclude fiducial placement
Inability to deliver target dose with CyberKnife due to inability to image fiducials
Inability to deliver target dose with CyberKnife due to normal tissue dose constraints
Decreased platelet count and/or anticoagulation parameters that would preclude transcutaneous placement of fiducials
Must not have taken a hypomethylating agent
Patients who have received prior therapies will be allowed to enroll after a wash-out period as follows assuming they have recovered from the side effects of such therapies:\r\n* Chemotherapy – 3 week wash-out period\r\n* Oral agents – 2 week wash-out period (except vemurafenib, which will require no wash-out period)\r\n* Investigational agents – 3 week wash-out period\r\n* Immunotherapy – 4 week wash-out period\r\n* Palliative radiation therapy to bone/brain – 2 week wash-out period\r\n* Major radiation or surgical procedure – 3 week wash-out period
MATCHED RELATED DONOR: History of prior malignancy; however, cancer survivors who have undergone potentially curative therapy may be considered for stem cell donation on a case-by-case basis; risk/benefit of the transplant and the possibility of transmitting viable tumor cells at the time of transplantation will be discussed with the patient
HAPLOIDENTICAL RELATED DONOR: History of prior malignancy; however, cancer survivors who have undergone potentially curative therapy may be considered for stem cell donation on a case-by-case basis; the risk/benefit of the transplant and the possibility of transmitting viable tumor cells at the time of transplantation will be discussed with the patient
Children with INSS 4 disease, age < 18 months with all 3 favorable biologic features (non-amplified MYCN, favorable pathology and deoxyribonucleic acid [DNA] index > 1)
Brainstem location is excluded from this study
Invasive ductal, medullary, papillary, colloid (mucinous) or tubular histologies
Patients presenting with abnormal microcalcifications on a screening mammogram must have radiographically confirmed excision of the suspicious microcalcifications, either by specimen radiograph or post-biopsy mammograms
Pure DCIS
Clear delineation of the extent of the lumpectomy cavity is not possible
Paget’s disease of the nipple
Step 1 subjects only: metastatic breast patients refractory to at least one standard therapy, with easily accessible metastatic deposits (cutaneous, subcutaneous, or superficial and/or palpable adenopathy/mass)
Uncontrolled infection, not responding to appropriate antimicrobial agents after seven days of therapy; the protocol principal investigator (PI) is the final arbiter of eligibility
Metastases beyond the cranial vault
Subject presents an increased surgical risk including abnormally positioned carotid artery or an inability to obtain adequate exposure for transoral surgery
Known mitochondrial disorder caused by mutations in mitochondrial deoxyribonucleic acid (DNA) polymerase gamma
Positive leukocytotoxic crossmatch
DONOR: Positive infectious disease test as dictated by blood collection center’s standard operating procedure (SOP)
Written informed consent obtained prior to enrolling in roll-over study and receiving study medication • If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness
Sexually active males unless they use a condom during intercourse while taking drug and for 1 months after pasireotide s.c. last dose and 3 months after pasireotide LAR last dose and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid If a study patient or partner becomes pregnant or suspects being pregnant during the study or within 1 month after the final dose of pasireotide s.c. or 3 months after the final dose of pasireotide LAR, the Study Doctor needs to be informed immediately and ongoing study treatment with pasireotide has to be stopped immediately For patients taking pasireotide LAR, the future dose injections will be cancelled.
Patients must demonstrate active noninfectious inflammatory pustular skin lesions resembling pustular psoriasis and involving >= 5% total body surface area, or palmoplantar involvement; conditions may include, but are not be limited to, pustular psoriasis, Sneddon-Wilkinson disease, subcorneal pustular dermatosis, reactive arthritis, palmoplantar pustulosis, acrodermatitis continua of Hallopeau and palmoplantar pustular psoriasis
Patients must have histopathologic confirmation of epidermal neutrophilic pustular skin disease
Other defined dermatologic conditions which may include pustules as part of the clinical presentation, but which clinically and/or histologically do not resemble pustular psoriasis; examples include, but are not limited to acute generalized exanthematous pustulosis (AGEP, a drug-induced pustular dermatosis typically caused by beta-lactam antibiotics, tetracyclines, oral antifungals and other drugs), bacterial or fungal folliculitis, cutaneous candidiasis, tinea pedis, tinea corporis, neutrophilic eccrine hidradenitis or eosinophilic pustular folliculitis (Ofuji syndrome)
Individuals with severe or uncontrolled recurrent cutaneous infections who are considered at elevated risk for serious infection on anakinra therapy will be excluded per physician discretion
Other immunoregulatory or immunodeficiency diseases, such as multiple sclerosis
Individuals with life-threatening or disabling inflammation of the eyes, gut or joints requiring urgent or immediate medical attention, or at the physician's discretion
Have a haploidentical family peripheral blood donor selected for best possible killer cell immunoglobulin-like receptor (KIR) reactivity; KIR typing will not be indicated if there is only one haploidentical donor; KIR typing is advised to be done if feasible and does not delay transplant
Newly diagnosed, untreated intraocular retinoblastoma; participants previously diagnosed with unilateral retinoblastoma treated surgically, with focal therapy or needing chemotherapy who develop asynchronous involvement of the contralateral eye, or patients with unilateral retinoblastoma treated only with enucleation or focal therapy who develop asynchronous involvement of the contralateral eye, will be eligible for study
Chronic (>1 month duration) IA, relapsed/recurrent IA, or refractory IA which has not responded to antifungal therapy.
Known hereditary problem of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
On artificial ventilation or receiving acute Continuous Positive Airway Pressure (CPAP)/Bilevel Positive Airway Pressure (BPAP) at the time of randomization.
Diagnosis of probable pancreatic cancer, distal common bile duct (CBD) cholangiocarcinoma and other periampullary cancers (histology not required)
Biliary strictures caused by malignancies other than pancreatic cancer, distal CBD cholangiocarcinoma and other periampullary cancers
Surgically altered biliary tract anatomy, not including prior cholecystectomy
Patients for whom endoscopic techniques are contraindicated
If image guidance with daily cone beam CT with direct physician visual assessment is used for treatment positioning, the presence of markers or clips in the surgical bed is recommended but not required. If cone beam CT imaging will NOT be used for image guidance, then the patient must be prepared to have 2 fiducial markers minimum, 3 preferred, placed prior to treatment (if not previously done).
Paget's disease of the nipple.
Histologically and cytologically proven bile duct cancer of any type (including intrahepatic cholangiocarcinomas, extrahepatic primary cholangiocarcinomas, hilar cholangiocarcinomas, cholangiocarcinomas located in the gall bladder or hepatic capsule effraction, and carcinoma of the Ampulla of Vater, etc.) that is not amenable to surgery, radiation, or combined modality therapy with curative intent, and has failed or is not eligible for available chemotherapies such as gemcitabine with or without platinum
Patients with baseline troponin levels greater than the institutional limit of normal
Patients must have high-risk NB (including v-myc myelocytomatosis viral related oncogene [MYCN] amplified stage 2/3/4/4S of any age and MYCN-non-amplified stage 4 in patients greater than 18 months of age) AND:\r\n* Phase I: Patients must have refractory or relapsed NB, resistant to standard therapy; for NB standard therapy includes intensive induction chemotherapy, followed by a variety of consolidation or salvage therapies, depending on response\r\n* Phase II: Patients must have primary or secondary refractory disease in BM, defined as morphologic evidence of NB in BM and/or abnormal 123 iodine (I)-MIBG uptake in osteomedullary sites, OR patients are in >= 2nd CR/VGPR
Patients must be on continuous TKI therapy for management of their CML. Any commercially available and FDA- approved TKI can be used, i.e., imatinib mesylate (IM), nilotinib (NIL) or dasatinib (DAS). Patients may be receiving TKI at entry in the frontline or salvage setting, including patients currently on imatinib after alpha-interferon failure or on dasatinib or nilotinib after failure to prior therapy including imatinib.
Patients must have detectable BCR-ABL transcript levels meeting at least 1 of the following criteria: Patient has never achieved a major molecular response (MMR, as defined by a BCR-ABL/ABL </=0.1% in the international scale (currently equivalent to 0.28 in the MDACC molecular diagnostic laboratory), & transcript levels have shown in at least 2 consecutive measures separated by at least 1 month to have increased by any value; or achieved a major molecular response which has been lost, with an interim increase in transcript levels by at least one-log, confirmed in two consecutive analyses separated by at least 1 month; or patient has received therapy for at least 2 years & lacks a sustained major molecular response; or patient has received therapy for at least 5 years & lacks a sustained complete molecular response (CMR, defined as transcript levels still detectable in the MDACC molecular diagnostic laboratory).
Patients should have findings of relapse by one or both of the following:\r\n* ALC > 5000 on 2 consecutive occasions and increasing\r\n* Any increase in lymphadenopathy over best response that has persisted for more than 3 months
A stress cardiac test (stress thallium, stress multigated acquisition [MUGA] scan, dobutamine echocardiogram or other stress test that will rule out cardiac ischemia) within 6 months of lymphodepletion (Turnstile II)
Hereditary fructose intolerance
MPN-associated myelofibrosis
Prior sotatercept
Hepatitis B or C seropositivity with evidence of ongoing liver damage, which would increase the likelihood of hepatic toxicities from the chemotherapy conditioning regimen and supportive treatments; if there is a positive result in the infectious disease testing that was not previously known, the patient will be referred to their primary physician and/or infectious disease specialist
Symptoms or manifestations of: a) gastroparesis; b) refractory gastroesophageal reflux disease (GERD) including persistent esophagitis, refractory heartburn, reflux-related laryngitis, and respiratory symptoms; or c) severe dyspepsia
Patients who are receiving antiarrhythmic medications with action on repolarization times (with prolongation of the QTc interval such as amiodarone, disopyramide, dofetilide, flecainide, ibutilide, quinidine, sotalol, dronedarone etc.)
Have a target tumor that is accessible for intratumoral administration by PTA (Percutaneous transluminal approach) or EUS (Endoscopic Ultrasound) guidance as determined by the radiologist/gastroenterologist performing the PTA/EUS injection.
Established refractoriness to CMC-544
Patients must be deemed to have borderline resectable disease (adapted from National Comprehensive Cancer Network [NCCN] Practice Guidelines in Oncology - v.2.2010) with no radiologic evidence of distant metastatic disease prior to registration; specifically, patients must have at least one designation of borderline resectable and no designation of unresectable disease
Patients should have an indication for therapy for their disease such as transfusion dependence or morbidity associated with their cytopenia(s) such as bleeding, severe fatigue, or frequent/multiple infections (eg. neutropenia)
Disease amenable to biopsy via percutaneous approach or other minimally invasive procedures such as thoracoscopy, bronchoscopy, laparoscopy, or gastrointestinal (GI) endoscopy
Patients with ATP-binding cassette, sub-family B (MDR/TAP) (ABCB)4 and ABCB11 genotypes associated with mithramycin-mediated hepatotoxicity
Patients who are concurrently receiving or requiring any of the following agents, which may increase the risk for mithramycin related toxicities, such as hemorrhage:\r\n* Thrombolytic agents\r\n* Aspirin or salicylate-containing products, which may increase risk of hemorrhage\r\n* Dextran\r\n* Dipyridamole\r\n* Sulfinpyrazone\r\n* Valproic acid\r\n* Clopidogrel
Certain scores on an anxiety and depression mood questionnaires
Presence of LGL clone prior to enrollment will not be an exclusion criterion if the LGL clone is < 25% of T cell population
Category I drugs that are generally accepted to have a risk of causing Torsades de Pointes including: (patients must discontinue drug 7 days prior to starting dasatinib):\r\n* Quinidine, procainamide, disopyramide\r\n* Amiodarone, sotalol, ibutilide, dofetilide\r\n* Erythromycin, clarithromycin\r\n* Chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide\r\n* Cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine
Participants with cervical cancer may undergo chemotherapy in conjunction with adjuvant proton therapy; the agents, doses, routes and schedule of administration will be determined by their attending gynecologic oncologist or medical oncologist
Evidence of extra-abdominal cancer dissemination or hematogenous cancer dissemination
Other rare lethal disorders of hematopoiesis and lymphohistiocytosis for which a T-cell depleted transplant is indicated (e.g., hemophagocytic lymphohistiocytosis; refractory; non-severe combined immunodeficiency [SCID] lethal genetic immunodeficiencies such as Wiskott Aldrich syndrome, CD40 ligand deficiency, autoimmune lymphoproliferative syndrome [ALPS])
Patients must be willing to forego other drug therapy against the tumor while being treated with pulse dosing of lapatinib and temozolomide and radiation and subsequently pulse dosing lapatinib and temozolomide
Patients who have any disease that will obscure toxicity or dangerously alter drug metabolism
For dose expansion phase: patients must have EphA2 overexpression overall H-score of 3 or above in immunohistochemistry (IHC) evaluation; Clinical Laboratory Improvement Amendments (CLIA) certified EphA2 IHC staining to be performed on formalin fixed, paraffin-embedded tissue sections using monoclonal EphA2 antibody; EphA2 expression to be assessed through a combo of % of positive cells and staining intensity; the % of positive cells will be rated: 0 points (pts), 0 to 5%; 2 pts, 6 to 50%; 3 pts, 50%; the staining intensity will be rated as follows: 1 pt, weak intensity; 2 pts, moderate intensity; 3 pts, strong intensity; pts for expression and % of positive cells will be added; an overall score will be assigned; tumors to be categorized into 4 groups: negative (overall score 0), 5% cells stained, regardless of intensity; weak expression (overall score 1), 1 - 2 pts; moderate expression (overall score 2), 3 - 4 pts; and strong expression (overall score 3), 5 - 6 pts; overall H-score of 3 or above will be defined as EphA2 overexpression in tumor cells
Must have clinically severe SCD (SS, SC or SBeta0 Thal) or thalassemia major and be eligible for myeloablative SCT
Sufficient physiological reserves
Patients with biopsy proven locally advanced sinus, nasal cavity, hard palate, soft palate, major or minor salivary gland tumors, or lacrimal apparatus, with nasal cavity, sinus, auditory canal, or skull base involvement are eligible
Patients with a hypersensitivity to halichondrin B and/or halichondrin B chemical derivative
Patients using any of the following medications: mesoridazine, dronedarone, thioridazine, ziprasidone, levomethadyl, and saquinavir for vemurafenib/sorafenib arm
Pathologically documented EBV antigen positive lymphoproliferative disease, lymphoma or other EBV-associated malignancy, OR
Evaluable disease as demonstrated by clinical and/or radiologic studies with current or prior elevated blood levels of EBV-deoxyribonucleic acid (DNA) exceeding 500 copies/ml by quantitative real time polymerase chain reaction (PCR), OR
EBV-specific T-cells are available for adoptive immune cell therapy from a consenting third party donor; the third party EBV CTLs to be administered will be selected on the basis of two criteria: 1) that they are matched for at least 2 HLA antigens and 2) that they are restricted by an allele shared with the EBV+ malignancy (if known), or with the donor in HSCT recipients, or patient in organ transplant or immunodeficient patients
Patients who develop EBV lymphomas or lymphoproliferative diseases or other EBV-associated malignancy as a consequence of profound immunodeficiencies associated with a congenital immune deficit or acquired as a sequela of anti-neoplastic or immunosuppressive therapy; for these patients, normal, EBV specific T-cells from third party seropositive donors who are HLA compatible in 1) at least 2 HLA antigens and 2) one restricted allele shared by the patient will be used; again, selection of T cells known to be restricted by an allele shared by the patient will be given priority
Patients who develop other EBV-associated malignancies without pre-existing immune deficiency, including: EBV+ Hodgkin's and non-Hodgkin's disease, EBV+ nasopharyngeal carcinoma, EBV+ hemophagocytic lymphohistiocytosis, or EBV+ leiomyosarcoma; normal, EBV specific T-cells from third party seropositive donors who are HLA compatible in 1) at least 2 HLA antigens and 2) one restricted allele shared by the patient will be used; again, selection of T cells known to be restricted by an HLA allele shared by the patient will be given priority
For subjects with HIV-associated entered after a tolerable dose has been determined, KS lesions must be either:\r\n* Increasing despite HAART and HIV suppression below the limit of detection (48 copies/mL) in the two months prior to screening or\r\n* Stable despite HAART for at least three months; stable disease must be symptomatic (examples of symptomatic disease include disease associated with pain, edema, psychological distress and/or social withdrawal)
Any abnormality that would be scored as a >= grade 3 toxicity by CTCAE, except:\r\n* Obesity is not considered an abnormality for the purposes of eligibility assessment unless in the opinion of the principal investigator or lead associate investigator its clinical consequences in a particular subject places the subject at unacceptable risk if they were to participate in the study or confounds the ability to interpret data from the study\r\n* Lymphopenia\r\n* Asymptomatic hyperuricemia, hypophosphatemia, or creatine kinase (CK) elevations\r\n* Direct manifestations of KS\r\n* Direct manifestations of HIV infection, except for neurologic or cardiac manifestations\r\n* Direct manifestations of HIV therapy, except for neurologic or cardiac manifestations
ABT-888 is primarily excreted in the urine, and is not even metabolized by the liver; thus such degree of hepatic impairment is not expected to affect the dosing of ABT-888
Any cytogenetic abnormality in the bone marrow that is known to be associated with or predictive of myelodysplasia is excluded; this includes, but is not limited to, del(5), del(7), del(11)
Persistent marrow involvement (> 10%) with HL after salvage cytoreductive therapy and before stem cell mobilization
Patient must present with indications for diagnostic or therapeutic approaches for benign and/or malignant diseases of the oral cavity or laryngopharynx (including the neoplastic lesions of the tongue, tongue base, retromolar trigone, tonsils, palate, posterior and lateral pharynx, glottic, supraglottic and subglottic larynx)
Inability to adequately visualize anatomy to perform the diagnostic or therapeutic surgical approach transorally
Brain edema and/or mass effect that causes midline shift or shift in wall of the third (3rd) ventricle of more than 10-mm.
Targeted area (i.e.: ROT) less than 5 millimeters from primary branches of cerebral vessels, dural sinuses, the hypophysis or cranial nerves
Containing calcifications in the focused ultrasound sonication beam path in the event system tools cannot tailor the treatment around these calcification spots
More than 30% of the skull area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), or atrophy of the scalp.
Symptoms and signs of increased intracranial pressure (e.g., headache, nausea, vomiting, lethargy, and papilledema).
Unstable hemodynamic status including:
At least 2 months from completion of temozolomide (to be consistent with the “rechallenge” group from Perry et al. JCO 2010)
Pathologically confirmed KSHV-MCD
Elevated C-reactive protein (CRP) (CRP > 3 mg/L) probably or definitely attributable to KSHV-MCD
Any abnormality that would be scored as NCI Common Toxicity Criteria (CTC) grade 3 toxicity that is unrelated to HIV, its treatment, or to MCD that would preclude protocol treatment; exceptions include:\r\n* Lymphopenia\r\n* Direct manifestations of Kaposi sarcoma or MCD\r\n* Direct manifestation of HIV (i.e. low cluster of differentiation [CD]4 count)\r\n* Direct manifestation of HIV therapy (i.e. hyperbilirubinemia associated with protease inhibitors)\r\n* Asymptomatic hyperuricemia\r\n* Hypophosphatemia\r\n* Elevated creatinine kinase (CK) attributed to exercise
Patients with mixed chimerism (present of more than 5% recipient chimerism) at 6 months post transplant will not be started on the protocol until the chimerism changes back to > 98%
DONOR: Evidence of prior sensitization to EBV by EBV serology testing (seropositive)
Exposure to more than one prior anti-tubulin/microtubule agent
Self-reported race of either African American or Caucasian
Patients with foreign body intracranially, such as bullet fragments, are not allowed, with the exception of VP-shunts (non-programmable) and Ommaya catheters
Had prior exposure to an immuno-oncology or pyrrolobenzodiazepine (PBD)-based drug
Subjects with active Epstein-Barr virus (EBV) unrelated to underlying lymphoma (positive serology for anti-EBV virus capsid antigen [VCA] IgM antibody and negative for anti-EBV Epstein-Barr nuclear antigen [EBNA] IgG antibody, or clinical manifestations and positive EBV PCR consistent with active EBV infection)
Have not received a TKI with pan-HER activity (eg, afatinib, neratinib, or dacomitinib).
Has a mitotic index <2 mitoses/2 mm2 for typical carcinoid (TC) and <10 mitoses/2 mm2 and/or foci of necrosis for atypical carcinoid (AC)
Positive Somatostatin receptors (SSTR) imaging
Parts 1 and 2:
Parts 3 and 4:
Part 1: 0 or 1
Parts 2, 3 and 4: 0, 1, or 2
Recent (< 12 months) active diverticulitis
For patients with non-measurable, structural disease the following must apply:\r\n* Undetectable thyroglobulin antibody AND\r\n* A serum thyroglobulin of 10 ng/ml or greater in the context of suppressed thyroid-stimulating hormone (TSH) (TSH =< 0.4 mcU/ml) =< 28 days prior to study registration; use of any thyroglobulin assay is allowed, though all serum thyroglobulin measurements for study purposes must be conducted with the same thyroglobulin assay
Patients with del(17p) confirmed by FISH in >= 20% of cells or on stimulated karyotype
Patients with unmutated IGHV who also have a complex karyotype on a stimulated karyotype
Tumors will be deemed Wnt positive if, at the time of central analysis, there is:\r\n* Monosomy 6 as determined by array comparative genomic hybridization (CGH)\r\n* Gene transcript detection by NanoString supporting Wnt+ medulloblastoma\r\n* Absence of large-cell, anaplastic histology\r\n* Nuclear b-catenin immunohistochemistry (IHC) result will be determined, but not required for the diagnosis
Diagnostic imaging (pre and post contrast) must be forwarded to Dana-Farber Cancer Institute (DFCI) for central review to confirm eligibility
Patients of Asian descent
A reasonable suspicion of ovarian cancer by the treating oncologist is required, evidenced by abdominal carcinomatosis, omental caking, pleural effusions or ascites AND an elevated CA125 > 250 OR CA125:carcinoembryonic antigen (CEA) ratio > 25 OR CA125 =< 250 with no evidence of gastrointestinal (GI) cancer
ELIGIBILITY CRITERIA FOR REGISTRATION: subjects for whom neoadjuvant chemotherapy followed by interval cytoreductive surgery is planned must have fine needle aspirate (FNA) or other cytology showing adenocarcinoma OR core biopsies OR surgically directed biopsies showing adenocarcinoma AND CA125 over 250 OR CA125:CEA ratio > 25 OR CA =< 250 with no evidence of GI cancer; they should have presumed stage III or IV disease, generally based on abdominal carcinomatosis, omental caking, pleural effusions or ascites
Treatment-related mortality (TRM) score < 9.21 corresponding to a TRM rate of 3% when chemotherapy of similar intensity as proposed here is administered to inpatients
Fibrinogen > 200
Para-aortic or inguinal metastasis
Patients with any disease that would obscure toxicity or dangerously alter drug metabolism
Bulky disease in the fissure preventing lung-sparing pleural IMRT
Patients with any infectious process that, in the opinion of the investigator, could worsen or its outcome be affected as a result of the investigational therapy
Patients who have developed anaphylactic responses to other vaccines
Histologically documented uterine carcinosarcoma with no visible residual disease
Other baseline neurocognitive or emotional disorders or deficits, including but not limited to head injury, cardiovascular accident (CVA), transient ischemic attack (TIA), or other cerebral insults with residual neuropsychiatric deficits, psychiatric disorders, learning disabilities, human immunodeficiency virus (HIV) positivity or other medical conditions at high risk of causing neurocognitive decline or emotional instability
Planning target volume (PTV) must be encompassed in a reasonable SBRT “portal” as defined by the treating radiation oncologist
Non-adenocarcinomas, adenosquamous carcinomas, islet cell carcinomas, cystadenomas, cystadenocarcinomas, carcinoid tumors, duodenal carcinomas, distal bile duct, and ampullary carcinomas are not eligible
Diagnosis of NF2 by National Institutes of Health (NIH) criteria (1988) with evidence of either:\r\n* Bilateral vestibular schwannomas, or\r\n* First-degree family relative with NF2 and either unilateral vestibular schwannomas (VS) or any 2 of: meningioma, schwannoma, glioma, neurofibroma, or juvenile posterior subcapsular lens opacity
Patients must have at least one unresected VS
FA complementation group A as determined by somatic cell hybrids, molecular characterization, western blot analysis, acquisition of mitomycin C resistance after in vitro lentiviral transduction with a vector bearing the complementary deoxyribonucleic acid (cDNA) for Fanconi complementation group A, or other clinically certified method of complementation group analysis
Pregnancy or lactation; females of childbearing potential and males who are admitted to the study will be advised that the study procedures and study drugs may be teratogenic, and they will be required to take adequate measures to prevent conception for the duration of the study
Patients with NO elevation of serum and/or CSF HCGB and AFP MUST have histological diagnosis of malignant germ cell tumor (GCT) or germinoma
Paget's disease of the nipple
One of the following, in order to lower risk of graft rejection: cytotoxic chemotherapy, an adequate course of 5-azacitidine or decitabine, or alemtuzumab within 3 months prior to start of conditioning; or previous BMT within 6 months prior to start of conditioning; Note: patients who have received treatment outside of these windows may be eligible if it is deemed sufficient to reduce graft rejection risk; this will be decided on a case-by-case basis by the Principal Investigator (PI) or co-PI
EBV seropositivity (can be pending at this time)
Psychiatric disturbance
Any contraindications to angiography and hepatic artery catheterization such as: History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine that cannot be corrected or premedicated; Bleeding diathesis, not correctable by usual forms of therapy; Severe peripheral vascular disease that would preclude catheterization.
Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs in a single treatment
MATCHED RELATED DONOR: History of prior malignancy; however, cancer survivors who have undergone potentially curative therapy may be considered for stem cell donation on a case-by-case basis; the risk/benefit of the transplant and the possibility of transmitting viable tumor cells at the time of transplantation will be discussed with the patient
Other rare lethal disorders of hematopoiesis and lymphopoiesis for which a T-cell depleted transplant is indicated (e.g. hemophagocytic lymphohistiocytosis; refractory aplastic anemia or congenital cytopenias; non-severe combined immunodeficiency [SCID] lethal genetic immunodeficiencies such as Wiskott Aldrich syndrome, CD40 ligand deficiency or, autoimmune lymphoproliferative syndrome [ALPS], as well as refractory autoimmune cytopenias, paroxysmal nocturnal hemoglobinuria [PNH], metabolic storage diseases or heavily transfused congenital hemoglobinopathies)
Patients with clinically suspected dense intraperitoneal adhesions preventing adequate IP distribution
HSV-1 Seropositive
Known existing uncontrolled coagulopathy, hemorrhagic disorder, or inability to discontinue Coumadin or Plavix for 5 days prior to each treatment (except for prophylaxis against portacath-associated thrombosis, which does not require cessation of therapy)
NSCLC expanded cohort only: total of 20 never smokers and non-smokers; never smokers are defined as individuals who have never smoked and non-smokers are defined as individuals with a =<10 pack year history and have quit > 15 years
Intraperitoneal ports may be placed during or at any time separate from surgical debulking; provided the patient has been allowed at least 4 weeks to recover from surgical debulking, no additional recovery time is required for port placement
Patients must undergo a peritoneal scan documenting at least one working intraperitoneal port prior to receiving chemotherapy
One of the following:\r\n* At least 2 prior courses of purine analog\r\n* 1 prior course of purine analog plus >= 1 course of rituximab if the response to the course of purine analog lasted < 1 year\r\n* Diagnosis of HCL variant (HCLv)\r\n* Unmutated (> 98% homology to germline) IGHV4-34+expressing HCL/HCLv
Receipt of a live vaccine within 4 weeks prior to randomization; efficacy and/or safety of immunization during periods of B-cell depletion have not been adequately studied; it is recommended that a patient’s vaccination record and possible requirements be reviewed; the patient may have any required vaccination/booster administered at least 4 weeks prior to the initiation of study treatment; review of the patient’s immunization status for the following vaccinations is recommended: tetanus; diphtheria; influenza; pneumococcal polysaccharide; varicella; measles, mumps and rubella (MMR); and hepatitis B; patients who are considered to be at high risk for hepatitis B virus (HBV) infection and for whom the investigator has determined that immunization is indicated should complete the entire HBV vaccine series at least 4 weeks prior to participation in the study
patients who are immunocompetent
Patients with cytologic evidence of glandular dysplasia
Prostate volume: =< 100 cc\r\n* Determined using: volume = ?/6 x length x height x width\r\n* Measurement from CT or ultrasound =< 90 days prior to registration
Growing teratoma syndrome, defined as enlarging tumor masses with normal serum markers during chemotherapy for nonseminomatous GCT
Subjects whose physicians determine that anti-HSV antiviral therapy (such as acyclovir, ganciclovir, foscarnet, etc.) cannot be safely discontinued from 2 days prior to being administered HSV1716 to 28 days following administration should not be in the study
American Joint Committee on Cancer (AJCC) stage 0-IIIa (pathologic stage Tis, T1N0, T2N0, T1N1a, T2N1a, T1N2a, T2N2a, M0) histologically confirmed ductal carcinoma in-situ or invasive carcinoma of the breast with a lesion =< 5 cm treated with lumpectomy and either sentinel node biopsy or axillary dissection (if invasive carcinoma is present)
Patients with Paget’s disease of the nipple
Available autologous transduced cytotoxic T lymphocytes with >= 15% expression of HER2 CAR and killing of HER2-positive targets >= 20% in cytotoxicity assay
25(OH) D3 level less than 40 ng/ml within 3 months of initiation of study; most recent 25 hydroxy D level within last 3 months would be used
Patients receiving finasteride (Proscar) or dutasteride (Avodart) or men who have received either agent within 90 days of entry are ineligible
Prior radioimmunotherapy
Patients with loss of normal vertebral height, due to for example compression fracture or other process, prior to treatment are not allowed; patients with normal height and compression fracture are allowed
If recent mold infection, e.g., Aspergillus, must be cleared by infectious disease to proceed
DONOR: The unmanipulated CB unit(s) will be Food and Drug Administration (FDA) licensed or will be obtained under a separate investigational new drug (IND), such as the National Marrow Donor Program (NMDP) Protocol 10-CBA conducted under BB IND-7555 or another IND sponsored by (1) a participating institution or (2) an investigator at FHCRC or one of the participating institutions
Patients must have had a response to chemotherapy, which the investigator feels is likely to resulting systemic control of the cancer; in most instances, this would reflect a major response (i.e. > or = 90% reduction of tumor), though a lower percentage may be acceptable if the investigator feels the residual reflects another component, such as transitional cell carcinoma (TCC); Dr Arlene Siefker-Radtke will serve as the final arbiter when questions regarding response arise
Admission for UCBT must be within an acceptable time period after the pre-allograft chemotherapy
Units with attached segments for confirmatory typing will be given preference
Acute leukemia in morphologic relapse or with morphologic persistent disease (cytogenetic or molecular persistence/relapse in morphologic CR are eligible); MDS or CML or other myeloproliferative disorder with > 5% blasts; aggressive lymphoma or HL with POD after salvage chemotherapy
If recent mold infection, e.g., Aspergillus, must be cleared by infectious disease
Myeloproliferative syndromes
Patients must be consulted to avoid impregnating partner
Must not be taking a drug specifically known to interact with VPA for at least 2 weeks prior to initiating the trial; including but not limited to: Aspirin, Felbamate, Rifampin, Amitriptyline/Nortriptyline, Carbamazepine, Clonazepam, Diazepam, Ethosuximide, Lamotrigine, Phenobarbital, Primidone, Phenytoin, Tolbutamide, Warfarin, Zidovudine
Three lumens of central vascular access will be required for all patients entered on protocol due to the need for a dedicated line for continuous infusion cyclosporine
Recipients will fall under one of the following disease categories:
Life expectancy reasonably adequate for evaluating the treatment effect
Verified by morphology and confirmed by cytochemistry and immunophenotyping
MLL status unknown
MLL rearranged AND age < 6 months AND WBC < 300 x 10^9/L AND prednisone good response
WBC ? 300 x 10^9/L AND/OR prednisone poor response
Mature B-ALL, defined by the immunophenotypical presence of surface immunoglobulins or t(8;14) and breakpoint as in B-ALL
Confirmed diagnosis of metastatic intrahepatic carcinoma; the histopathology confirmation criterion may be waived in patients with a radiographically identifiable liver mass, known laboratory or clinical risk factors for cancer or elevated tumor markers such as AFP
Confirmed diagnosis of intrahepatic carcinoma; the histopathology confirmation criterion may be waived in patients with a radiographically identifiable liver mass, known laboratory or clinical risk factors for cancer or elevated tumor markers such as alpha fetoprotein (AFP)
Plus any of the following: \r\n- Stroke or central nervous system event lasting more than 24 hours\r\n- Magnetic resonance imaging (MRI) changes indicative of brain parenchymal damage\r\n- Magnetic resonance angiogram (MRA) evidence of cerebrovascular disease\r\n- Acute chest syndrome requiring exchange transfusion or hospitalization\r\n- Recurrent vaso-occlusive pain crisis (more than 2/year for the last 2 years)\r\n- Stage I or II sickle lung disease\r\n- Sickle retinopathy\r\n- Osteonecrosis\r\n- Red cell alloimmunization (> 2 antibodies) during long-term transfusion\r\n- Constellation of dactylitis in the first year of life and a baseline hemoglobin < 7 g/dL and leukocytosis (> 13.4 x 10^3/mm^3) in the absence of infection during the second year of life\r\n- History of invasive pneumococcal disease\r\n- Pitted red blood cell (RBC) count > 3.5% during the first year of life\r\n- Abnormal transcranial Doppler\r\n- Transfusion dependence\r\n- Beta thalassemia major
DONOR: ABO compatibility (in order of priority) \r\n- Compatible\r\n- Major incompatibility\r\n- Minor incompatibility\r\n- Major and minor incompatibility
Poor mouth opening, with maximal opening less than 1.5 cm
Hemophagocytic lymphohistiocytosis (HLH), familial hemophagocytic lymphohistiocytosis (FLH), viral-associated hemophagocytic syndrome (VAHS), X-linked lymphoproliferative disease (XLP), severe chronic active Epstein Barr virus infection (SCAEBV) with predilection for T- or natural killer (NK)-cell malignancy
Patients with severe hepatic disease (direct bilirubin greater than 3 ug/dl or serum glutamic pyruvate transaminase [SGPT] greater than 500 ug/dl)
Patients with a severe infection that on evaluation by the Principal Investigator precludes ablative chemotherapy or successful transplantation
A stress cardiac test (stress thallium, stress multi gated acquisition scan [MUGA], dobutamine echocardiogram or other stress test that will rule out cardiac ischemia) within 6 months of lymphodepletion (Turnstile II - Chemotherapy/Cell Infusion-Inclusion Criteria)
Myeloproliferative syndromes
If 2 UCB units are required to reach the target cell dose, each unit must be a 4-6 HLAA, B, DRB1 antigen match to each other, as well as a 4-6 antigen match to the recipient
Myeloproliferative syndromes
Alpha feto protein (AFP) < 50 ug/L (for non-hepatitis B or C patients); alpha fetoprotein > 50 ug/L is allowed for patients with hepatitis B or C cirrhosis
Patients must demonstrate the ability and willingness to eat solid food and SV/placebo.
A known allergy to one or more components of SV, namely soy beans, mushrooms, mung beans, red dates, scallion, garlic, lentil beans, leek, hawthorn fruit, onions, ginseng, angelica root, Chinese licorice, dandelion root, Senegal root, ginger, olives, sesame seed and parsley.
INCLUSION CRITERIA FOR CCT: patients must have MIBG-avid malignant CCT and evaluable disease on MIBG scan at time of enrollment on protocol
Patients must have no rapidly progressing or deteriorating neurologic examination
Patients with obstructive or symptomatic communicating hydrocephalus
Non-Hodgkin lymphoma (NHL) previously untreated with cytotoxic chemotherapy; however, patients may be entered if they have had prior cyclophosphamide for an urgent problem at diagnosis (e.g. epidural cord compression, superior vena cava syndrome) and/or a single dose of intrathecal methotrexate (MTX) at the time of the pre-treatment diagnostic lumbar puncture
Platelet >= 75,000/mm^3 (unless impairment due to idiopathic thrombocytopenic purpura [ITP])
Inclusion Criteria:\n\n          -  Pathologically documented EBV antigen positive lymphoproliferative disease, lymphoma,\n             or other EBV-associated malignancy OR\n\n          -  Severely immunocompromised patients who develop blood levels of EBV DNA exceeding 500\n             copies/ml DNA, and are therefore at high risk for developing an EBV LPD\n\n        It is expected that five types of patients afflicted with EBV-associated lymphomas or\n        lymphoproliferative diseases will be referred and will consent to participate in this\n        trial. These are:\n\n          1. Patients developing or at risk for EBV lymphomas or lymphoproliferative disorders\n             following an allogeneic marrow transplant.\n\n          2. Patients developing or at risk for EBV lymphomas or lymphoproliferative disorders\n             following an allogeneic organ transplant.\n\n          3. Patients with AIDS developing EBV lymphomas or lymphoproliferative diseases as a\n             consequence of the profound acquired immunodeficiency induced by HIV.\n\n          4. Patients who develop EBV lymphomas or lymphoproliferative diseases as a consequence of\n             profound immunodeficiencies associated with a congenital immune deficit or acquired as\n             a sequela of anti-neoplastic or immunosuppressive therapy.\n\n          5. Patients who develop other EBV-associated malignancies without pre-existing immune\n             deficiency, including: EBV+ Hodgkin's and Non- Hodgkin's disease, EBV+ nasopharyngeal\n             carcinoma, EBV+ hemophagocytic lymphohistiocytosis, or EBV+ leiomyosarcoma.\n\n        Exclusion Criteria:\n\n        The following patients will be excluded from this study:\n\n          -  Moribund patients who, by virtue of heart, kidney, liver, lung, or neurologic\n             dysfunction not related to lymphoma, are unlikely to survive the 6-8 weeks required\n             for in vitro generation and expansion of the EBV-specific T cells to be used for\n             therapy and the subsequent 3 weeks required to achieve an initial assessment of the\n             effects of infusions of EBV-specific T cells.\n\n          -  Pregnancy does not constitute a contraindication to infusions of EBV-specific T cells.
No prior systemic chemotherapy; patients may be entered if they have had prior limited-field radiotherapy, a short course of glucocorticoids and/or cyclophosphamide for an urgent problem at diagnosis (e.g. epidural cord compression, superior vena cava syndrome)
Must have indication for treatment (adapted from National Comprehensive Cancer Network [NCCN] 2015 guidelines)\r\n* Any of the following constitute an indication for treatment:\r\n** Significant symptoms due to any iBCL: Which may include pain/discomfort, limitation of function, fatigue/malaise/constitutional symptoms, B-symptoms (fever, weight loss, night sweats), pruritus\r\n** Threatened end-organ function due to any iBCL\r\n** Progressive cytopenia secondary to any iBCL\r\n** Steady progression of follicular lymphoma (FL) and marginal zone lymphoma (MZL)
Be in urgent need of therapy for lymphoma related complications (such as hyperviscosity syndrome) and those with bulky disease
Must have determination of biomarker (BM) status (either BM positive [+] or BM negative [-]) by the sponsor's blood based assay
Patients with uncontrolled or symptomatic kidney stones; NOTE: Patients with calcium oxalate crystals on baseline urinalysis or a history of symptomatic calcium oxalate stones must be seen by the Nephrology Stone Clinic and placed on a low oxalate diet (< 100 mg oxalate/day) prior to enrollment
Known paroxysmal nocturnal hemoglobinuria (PNH)
Group 3: KRAS mutant CRC.(Part B)
creatinine kinase - MB, troponin-I, and troponin-T within normal limits
Current evidence of endocrine alteration of calcium Phosphate homeostasis (e.g. parathyroid disorder, history of parathyroidectomy, tumor lysis, tumoral calcinosis, paraneoplastic hypercalcemia)
Confirmed diagnosis of primary cold agglutinin disease (CAgD) based on the following criteria: a) Chronic hemolysis; b) Polyspecific direct antiglobulin test (DAT) positive; c) Monospecific DAT strongly positive for C3d; d) Cold agglutinin titer >= 64 at 4 degree celsius; e) Immunoglobulin G (IgG) DAT less than or equal to (<=) 1+, and f) No overt malignant disease
Patients must have erythematous manifestations of cutaneous aGvHD. Characteristics of the rash must indicate active inflammation (red coloration) as distinct from resolving inflammation (brown coloration).
Providers and patients must be willing to defer new systemic or cutaneous topical treatment of aGvHD for at least 36 hours after administration of Neihulizumab.
Patients known to have CMV, adenovirus, human herpes virus 6 (HHV6), Epstein Barr virus (EBV) or any hepatitis viremia from screening according to institutional standard practice
Other leukemia subtypes: A major effort in the field of hematology is to identify patients who are of high risk for treatment failure so that patients can be appropriately stratified to either more (or less) intensive therapy; this effort is continually ongoing and retrospective studies identify new disease features or characteristics that are associated with treatment outcomes; therefore, if new features are identified after the writing of this protocol, patients can be enrolled with the approval of two members of the study committee
Practice total abstinence from sexual intercourse (minimum 1 complete menstrual cycle)
Prior treatment of chronic HCV infection with a direct acting antiviral agent(s): telaprevir, boceprevir, sofosbuvir, simeprevir, or other direct acting antiviral
HCV genotype performed during screening indicates infection with genotype 2 or 3
Chronic ITP (ITP lasting for greator than or equal to ([>=] 12 months) as defined in the protocol
cT2N0 - tumour invasion into muscularis propria, no radiographic evidence of mesorectal nodal metastasis, tumour deposits or vascular invasion.
cT3a,bN0- tumour invasion through the muscularis propria no more than 5 mm into the subserosa/perirectal tissue and clear of the circumferential radial margin (CRM). Absence of radiographic evidence of mesorectal nodal metastasis, tumour deposits or lymphovascular invasion.
Mid to low-lying tumour eligible for local tumour excision in the opinion of the treating surgeon.
Mismatch repair deficiency as identified by immunohistochemistry or other institutional standard, or Epstein-Barr virus positivity as determined by in situ hybridization or other institutional standard
completed the base trial and have shown a clinical benefit of SD or better and have never met any withdrawal criteria as defined in the tisotumab vedotin base protocol, or
Platelets >= 75,000 K/CUMM
Subject is receiving concomitant immunosuppressive therapy, defined as:\r\n* Immunosuppressants, including: tacrolimus, sirolimus, everolimus, cyclosporine, azathioprine, mycophenolate mofetil, antithymocyte globulin, basiliximab, belatacept\r\n* Systemic corticosteroids (except for short team treatment of allergic reactions or for treatment of immune related adverse events [irAE]); steroids with no or minimal systemic effect (topical, inhalation) are allowed\r\n* Chemotherapy\r\n* Immunotherapy\r\n* Monoclonal antibodies
Planned administration of cisplatin administered weekly or tri-weekly during RT
Presence of active infectious oral disease excluding oral candidiasis
Planned to receive IMRT with daily fractions of 2.0 Gy to 2.2 Gy to a cumulative dose of at least 60 Gy and a maximum of 72 Gy
Presence of active infectious disease excluding oral candidiasis
Presence of oral mucositis or any oral lesion that would confound the assessment of oral mucositis
Active systemic disease or condition known to impact the risk or course of oral mucositis including chronic immunosuppression and known seropositivity for HIV
Prior exposure to isatuximab or participated clinical studies with isatuximab.
Functioning intraperitoneal catheter
Consecutive patients with a newly diagnosed, objectively confirmed: symptomatic or unsuspected, proximal lower-limb DVT or symptomatic PE or unsuspected PE in a segmental or more proximal pulmonary artery;
thrombectomy, vena cava filter insertion, or thrombolysis used to manage the index episode;
indication for anticoagulant treatment for a disease other than the index VTE episode; Related to bleeding risk:
bacterial endocarditis;
Late-Gadolinum enhancement (LGE) on CMR indicative of cardiac amyloidosis
Subjects with a diagnosis of hereditary ATTR amyloidosis should have a known amyloidogenic transthyretin (TTR) mutation demonstrated by genotyping AND is recognised to be primarily associated with cardiomyopathy AND one of the following: Definite histochemical identification of amyloid by Congo red staining and green birefringence in crossed polarised light in cardiac or other tissue biopsy and identification of TTR as the amyloid fibril protein either by immunohistochemistry or proteomic analysis. Or Scintigraphy: 99m^Tc-DPD with Grade 2 cardiac uptake or 99m^Tc-PYP with either Grade 2 or 3 cardiac uptake.
Subjects with a diagnosis of wild type ATTR-CM must be negative by genotyping and have one of the following: Definite histochemical identification of amyloid by Congo red staining and green birefringence in crossed polarised light in cardiac or other tissue biopsy and identification of TTR as the amyloid fibril protein either by immunohistochemistry or proteomic analysis OR Scintigraphy 99m^Technetium-dicarboxypropane diphosphonate (99m^Tc-DPD) with Grade 2 cardiac uptake or 99m^ Technetium-pyrophosphate (99m^Tc-PYP) with Grade 2 or 3 cardiac uptake.
Sustained / symptomatic monomorphic ventricular tachycardia (VT), or rapid polymorphic VT, at screening
N-terminal pro b-type Natriuretic Peptide [(NT)-proBNP] >8500 nanograms (ng)/ Liter (L)
Inability to fit inside scanner due to body size (girth)
Intra- orbital metal fragments that have not been removed
TTR polyneuropathy and / or intracranial TTR involvement including ophthalmological disease
The need for treatment with medications with clinically-relevant metabolism by the cytochrome P450 (CYP) 3A4 isoenzyme within 3 hours before or after administration of SNX-5422
The need for treatment with medications with clinically-relevant metabolism by the cytochrome P450 (CYP) 3A4 isoenzyme within 3 hours before or after administration of SNX-5422
Hypersensitivity to the active pharmaceutical ingredient or any of the excipients of the IMPs, including Labrasol, butylated hydroxyanisole, and butylated Hydroxytoluene
Symptomatic lymphadenopathy
Bothersome cutaneous disease
?3 weeks for systemic retinoids, interferons, vorinostat, romidepsin, fusion proteins
Written informed consent obtained prior to enrolling in the roll-over study and receiving study medication. If consent cannot be expressed in writing, it must be formally documented and witnessed via an independent trusted witness.
Other serious co-morbid illness or compromised organ function
Serious nonmalignant disease
Patients must not have any active infectious process.
Participation in any other intraoperative margin assessment protocol that would affect data acquisition.
Must not have a serotonin-secreting carcinoid tumor or a prior history of drug-induced serotonin syndrome
Has a mental incapacity or language barriers precluding adequate understanding, co-operation, and compliance with the study requirements.
Baseline LIC >7 mg/g dw (measured by MRI);
Thalassemia syndromes;
Baseline LIC >30 mg/g dw (measured by MRI);
Able to take acetaminophen
Active suppurative cholangitis (hypotension, acidemia, mental status changes)
Targeted tumor(s) are ExAblate device accessible and are located in ribs, extremities (excluding joints), pelvis, shoulders and in the posterior aspects of the following spinal vertebra: Lumbar vertebra (L3 - L5), Sacral vertebra (S1 - S5)
Need surgical stabilization of the affected weight bearing bony structure (>7 fracture risk score, see Section 6.9) OR
NOT accessible to ExAblate device
Patients must meet all the University of Alabama at Birmingham (UAB) diagnosis and disease status criteria for clinical appropriateness for allogeneic HSCT derived from American Society for Blood and Marrow Transplantation (ASBMT) and National Comprehensive Cancer Network (NCCN) guidelines and updated annually
Patients must not have any significant organ system compromise except hematopoiesis as defined in the UAB eligibility checklist including, a Karnofsky performance status > 70% and a life expectancy assuming control of primary disease > 8 weeks
Infections requiring administration of ganciclovir, valganciclovir or acyclovir at the time of infusion: HSV-Tk cells can be administered after a 24-hour discontinuation interval of antiviral therapy
Castleman's disease (multi-centric disease)
Patient with one of the following documented mastocytosis as per WHO classification: Smouldering Systemic Mastocytosis, Indolent Systemic Mastocytosis, Cutaneous Mastocytosis
Handicapped status defined as at least two of the following handicaps, including at least one among pruritus, flushes, depression and asthenia: pruritus score ? 6, number of flushes per week ? 7, Hamilton rating scale (depression) ? 10, number of stools per day ? 4, number of mictions per day ? 8, Fatigue Impact Scale total score (asthenia) ? 40
Patients with OPA > 2 (moderate to intolerable general handicap)
Patient with one of the following mastocytosis: Systemic Mastocytosis with an Associated clonal Hematologic Non Mast cell lineage Disease (SM-AHNMD), Mast cell leukemia (MCL), Aggressive systemic mastocytosis (ASM)
C-Kit (CD117) positive tumours detected immuno-histochemically or PDGF positive if c-kit negative
Ki 67 < 10%
Presence of autonomous adrenocortical hormone secretion despite the absence of disease detectable with imaging techniques
Patients who require or are likely to require any strong modifier of CYP450 activity to be taken prior to milataxel administration
Palpable mass
Mass on mammography
Poor nutritional state (as determined by clinician)
Patients who will require APR or hand-sewn colo-anal anastomosis
Patients, who are participating in a previous Bayer/Onyx sponsored study that has reached its endpoint (statistical and regulatory or study end), and who are, in the opinion of the Investigator, expected to continue to have an overall positive benefit/risk from continuing treatment.
Satisfactory haematological or biochemical functions (tests should be carried out within 8 weeks prior to randomisation): Results of clinical investigations carried out within 8 weeks prior to randomisation can be used in place of the required screening investigations. Patients with mild laboratory abnormalities can be included at the discretion by the site principal investigator, and after approval by ASCOLT Trial Management Group
History of erosive GERD or active erosive GERD on gastroscopy.
Unexplained rise of CEA (i.e. smoker with elevated CEA will not be excluded)
Suicidal or homicidal ideation.
Having plans to leave the immediate geographical area within 9 months.
Karnofsky rating 70-100 (See Appendix A).
Symptoms and signs of increased intracranial pressure (e.g., headache, nausea, vomiting, lethargy, and papaedema).
Hepatitis B and C negative, unless the result is consistent with prior vaccination or prior infection with full recovery
Currently enrolled in Studies GS-US-352-0101, GS-US-352-1214, or GS-US-352-1154
Pre-pectoral implant placement
Requiring Wise pattern reduction of mastectomy skin flap
Patients should be in such a health condition in the opinion of the attending physician that with the administration of mifepristone benefits may outweigh risks
Participation in a TRACON Pharmaceuticals sponsored parent TRC105 study and, thought to have potential to derive clinical benefit from continued treatment with TRC105 in the opinion of the parent study investigator.
ability to begin TRC105 dosing on this protocol within 6 weeks from the subjects last dose of TRC105 in the parent TRC105 study
Demonstrated refractoriness or intolerance to standard approved therapy (lenalidomide in del(5q) MDS patients & azanucleosides in non-del(5q)patients).
For the diagnosis of CIN1, has a documented satisfactory colposcopy, ie, the entire lesion as well as the entire squamocolumnar junction is visualizible by colposcopy;
Atypical endometrial or glandular cells or evidence of invasive cervical carcinoma on cervical biopsy;
Current recognized immunodeficiency disease, including infection with HIV, cellular immunodeficiencies, hypogammaglobulinemia, or dysgammaglobulinemia, or hereditary or congenital immunodeficiencies.
Erythropoietin and darbopoietin-? are permitted;
Patients with M+ disease (defined as neuraxis dissemination either by imaging or by cytology)
Patients with gliomatosis cerebri type 1 or 2
Patients with known constitutional mismatch repair deficiency syndrome (CMMR-D)/biallelic mismatch repair deficiency (bMMRD)
Female patients who are pregnant are ineligible due to risks of fetal and teratogenic adverse events as seen in animal/human studies
Presence of any bladder or urethral anatomic feature that in the opinion of the investigator may prevent the safe placement, indwelling use, or removal of TAR 200.
Pyeloureteral tube externalized to the skin is exclusionary. Unilateral nephrostomy tube or ureteral stent is permitted as long as it does not interfere with placement or retention of TAR-200 in the bladder.
Indwelling catheters are not permitted.
Participant has a visual condition that compromises the ability to accurately measure visual acuity or assess visual activities of daily living (vADLs).
tubal sterilization, or
Subjects eligible for the Observation Arm must have had their central line removed and replaced within 96 hours of the qualifying blood culture (120 hours with Medical Monitor approval);
Subjects with the presence of a deep-seated intravascular source of infection (eg, endocarditis [as evidenced by vegetations on an echocardiogram or clinical suspicion] or septic thrombosis);
The total sum of Ad-p53 Injection Doses (mL) based upon the tumor volumes shown in Table 2 should be less than or equal to 25 mL as the MTD of Ad-p53 is 2.5 x1013 vp/treatment day.
Drugs that affect the CYP3A4 systems are allowed and essential for cancer patients, including anti-fungals but should be used with caution.
Patients who cannot hold instillation for 2 hours
Non-healing wounds on any part of the body.
A lesion that either:\r\n* Is intended to be accessed bronchoscopically OR\r\n* Is intended to be accessed with computed tomography (CT) guided transthoracic injection and in the estimation of the radiologist performing the procedure will not require transversing a bullae that significantly increases the risk of pneumothorax.
Evidence of active HepB, HepC, or HIV infection
The study will require that 50% of enrolled subjects have homozygous deletions, deleterious mutations, or both in one or more of the DNA damage response (DDR) genes; the other 50% of patients must have an intact DDR pathway
Tumor causing urinary outlet obstruction that requires catheterization for voiding; patients that require catheterization to void secondary to benign strictures or other non-cancer causes will be permitted to enroll
Presence of a known ibrutinib resistance mutation at ? 4% variant allele frequency OR < 4% with two separate measurements at least 4 weeks apart with increasing variant allele frequency
Evidence of EWS translocation by FISH or RT-PCR or Next Generation Sequencing (NGS). If available, NGS sequencing report should be submitted to Gradalis.
Tumor intended for immunotherapy manufacture is not embedded in bone and does not contain luminal tissue (e.g. bowel, ureter, bile duct).
History of other previous or concurrent cancer that would interfere with the determination of safety or efficacy assessment of RXDX-106 with respect to the qualifying solid tumor malignancy.
Patient's tumor must express specified biomarkers. Note: Patients who were previously screened for participation in other Immatics' sponsored clinical trials and whose biomarkers are positive for IMA202-101 based on IMA_Detect may enter IMA202-101 screening
Available IMA202 product passed all required release tests
Patients and/or families who are physically and psychologically unable to cooperate with the radiation safety isolation.
Urgent need of treatment to prevent acute neurologic deterioration, including urgent neurosurgery or radiotherapy
Willingness to avoid exposing breast skin to natural or artificial sunlight (i.e. tanning beds) for the duration of study agent dosing
Women receiving a “nipple delay” procedure prior to mastectomy
Women with skin diseases (psoriasis, eczema)
DCIS with focal invasion
Pathologic findings consistent with\r\n* atypical endometrial cells or serious glandular-cell atypia (atypical glandular cells, favor neoplasia cytology diagnosis)\r\n* evidence of cervical carcinoma on Pap smear or biopsy\r\n* more than two cervical quadrants of cervical intraepithelial neoplasia grade 3 (CIN 3) as visualized by colposcopy\r\n* nonvisual squamous columnar junction on colposcopy with no concurrent endocervical sampling performed
Inability to stop anticoagulants/antiplatelet therapy peri-operatively
Derived clinical benefit from IGN002, defined as CR, PR, or SD, in another Valor-sponsored IGN002-101 study (e.g., IGN002-101)
Tolerated IGN002 therapy in the other Valor-sponsored IGN002 study
Discontinued from another Valor IGN002 study due to an AE considered by the Investigator to be related to IGN002 treatment
Infectious disease testing will be done per Hemacare policy and AAAB guidelines
Positive infectious disease test as dictated by blood collection center’s standard operating procedure (SOP)
A diagnosis of basal cell nevus syndrome (BCNS) as defined in the Consensus Statement (Bree et al, American Journal of Medical Genetics [Am J Med Genet] Part A 155:2091-2097)\r\n* Major criteria are: \r\n** BCC prior to age 20 years, or excessive number of BCCs out of proportion to prior sun exposure and skin type\r\n** Keratocyst of the jaw prior to age 20\r\n** Palmar or plantar pitting\r\n** Lamellar calcification of the falx cerebri\r\n** Medulloblastoma\r\n** First degree relative with BCNS\r\n* Minor criteria are: \r\n** Rib anomalies, or other specific skeletal malformations including kyphoscoliosis and short 4th metacarpals\r\n** Macrocephaly\r\n** Cleft/lip or palate\r\n** Fibroma of the heart or ovary\r\n** Ocular abnormalities\r\n** Other rare abnormalities listed in the article by Bree et al\r\n* For diagnosis of BCNS, the patient must have either 2 major criteria, one major and two minor criteria, or one major criterion plus molecular confirmation of a patched 1 (PTCH1) gene mutation
Laboratory requirements: \r\n* If the patient has never had a skin biopsy to establish the histological diagnosis of BCC as part of his/her syndrome, then one lesion must be biopsied prior to entry into the trial\r\n* Any suspected BCC lesion of > 10 mm in diameter must be biopsied at the start of the trial, to establish the histological subtype of the BCC\r\n* Any presumed BCC lesion that fails to respond by the end of the trial must be biopsied to rule out an incorrect diagnosis as a reason for the lack of response\r\n* If a female patient suspects she is pregnant during the course of the trial, a serum pregnancy test will be administered and if positive, any further PDT treatments will be halted
Patients with a coexisting skin condition such as scleroderma, psoriasis, or eczema in the skin areas to be treated with PDT, that might interfere with response assessment
Patients with CEA plasma levels > 1000 ng/mL must be approved in advance by the Sponsor.
PREREGISTRATION (STEP 0): Peripheral blood must be collected for submission to Fred Hutchinson Cancer Research Center for central assessment of the establishment of BCR/ABL status to confirm patient’s eligibility for registration to Step 1; Fred Hutchinson will forward results within 1-2 business days of receipt of the peripheral blood to the submitting institution
Histologically or cytologically confirmed germ cell tumour (non-seminoma or seminoma); or exceptionally raised tumour markers (alpha-fetoprotein [AFP] >= 1000ng/mL and/or human chorionic gonadotropin [HCG] >= 5000 IU/L) without histologic or cytologic confirmation in the rare case where pattern of metastases consistent with germ cell tumor (GCT), high tumour burden, and a need to start therapy urgently
Intermediate or poor prognosis as defined by International Germ Cell Cancer Consensus Classification (IGCCC) classification (modified with different lactate dehydrogenase [LDH] criteria for intermediate risk non-seminoma, and inclusion of ovarian primaries); see below\r\n* Primary site: Testis or retro-peritoneum or mediastinum\r\n** Histology: Non-seminoma\r\n*** Prognostic category: Intermediate\r\n**** Clinical Factors: Testes/retroperitoneal primary and no liver, bone, brain or other non-pulmonary visceral metastases and intermediate markers – any of:\r\n***** AFP >= 1000 ng/mL and =< 10 000 ng/mL\r\n***** HCG >= 5000 IU/L and =< 50 000 IU/L\r\n***** LDH >= 3.0 x upper limit of normal (ULN) and =< 10 x ULN\r\n*** Prognostic category: Poor\r\n**** Clinical Factors: Mediastinal primary or liver, bone, brain or other non-pulmonary visceral metastases or poor markers – any of:\r\n***** AFP > 10 000 ng/mL or\r\n***** HCG > 50 000 IU/L or\r\n***** LDH > 10 x ULN\r\n** Histology: Seminoma\r\n*** Prognostic category: Intermediate\r\n**** Clinical factors: Any primary site and liver, bone, brain or other non-pulmonary visceral metastases and normal AFP, any HCG, any LDH\r\n* Primary site: Ovary\r\n** Histology: Malignant germ cell tumour histology (any of yolk sac, choriocarcinoma, embryonal carcinoma, mixed malignant GCT)\r\n*** Prognostic category: Federation of Gynecology and Obstetrics (FIGO)/Children's Oncology Group (COG) stage IV\r\n**** Distant metastases involving liver/spleen parenchyma and/or extra-abdominal organs (including but not limited to inguinal lymph nodes and lymph nodes outside abdominal cavity, lungs, bone, brain) and/or pleural effusion with positive cytology
Immuno-magnetically purged PBSCs are permitted, however a special exception protocol must be filed with the FDA and local IRB where patient will be infused to allow infusion of immunomagnetically purged PBSC; CD34+ selected cells are not permitted
Patients and/or families who are physically and psychologically unable to cooperate with the radiation safety isolation
A patient weight that would require exceeding a maximum total allowable dose of 131I-MIBG at the assigned dose level; the study committee will discuss treating such patients at a lower dose level if six patients have not yet been treated at that lower dose level
Subjects who are unwilling to minimize exposure with his/her blood or other body fluids to individuals who are at higher risks for HSV 1 induced complications (immunosuppressed individuals, HIV positive individuals, pregnant women, or children under the age of 1 year) during talimogene laherparepvec treatment and through 30 days after the last dose of talimogene laherparepvec
Part 2: presence of fatigue as defined FACIT-F subscale of ? 34 on a 0 to 52 scale (in which 52 = no fatigue and 0 =worst possible fatigue)
Part 2: patients with Cut Down, Annoyed, Guilty and Eye Opener-Adapted to Include Drugs (CAGE-AID) ? 2
Prior receipt of cumulative RAI doses in excess of 1000 mCi
Confirmed fungal infection (eg, Pneumocystis jirovecii etiology in patients with pneumonia) that justifies adding additional empiric antimicrobial therapy (eg, antifungals)
Confirmed viral infection that justifies adding additional empiric antiviral therapy (eg, ganciclovir, foscarnet)
Patient has developed a rash or symptoms of a rash (cutaneous burning) characteristic of an EGFR inhibitor (health-care provider report of the rash with no other documentation is permitted)
Patients with risk of broncho-aspiration based on documented swallowing test by a speech pathologist (if available)
Patients with corneal epitheliopathy or any eye disorder that may predispose the patients to this condition as judged by an ophthalmologist\r\n* Note: Low grades of superficial punctate keratitis, within the range seen in the normal population, should not lead to the exclusion of the patient
Has known gliomatous meningitis, extracranial disease, or multifocal disease.
Use of valproate in any of its indications (epilepsy, mood disorder). Valproate, due to its HDAC inhibiting activity is contraindicated. For those patients on valproate, valproate will need to be discontinued and switched to a different anti-epileptic agent or psychotropic agent. A washout period of 4 days from valproate acid will be allowed prior to enrolling into the trial.
At sites in the Southeastern U.S., subject must have negative serum test for galactose-alpha-1,3-galactose IgE (Note: positive test result is predictive of immediate-onset anaphylaxis reaction during first exposure to cetuximab, which is prevalent predominantly in limited geographic region of the Southeastern U.S.
Asplenia
Glasgow Coma Score of less than 15
Consented to genome sequencing and the database of genotypes and phenotypes (dbGaP)-based data sharing and has provided or will provide germline (PBMC) and tumor DNA/ribonucleic acid (RNA) samples of adequate quality for sequencing. (Acquisition of specimens for sequencing and the sequencing itself may be done as part of routine care or another research project.)
As this study aims to assess the immunogenicity of various vaccine plus adjuvant combinations, no prior immunotherapy will be permitted.
ENROLLMENT: Patients where the burden of pulmonary metastasis, location, or bulkiness of disease may cause high morbidity if localized swelling such as causing uncontrolled symptoms, oxygen dependence, or location near a major bronchi as determined by investigator.
Prior cystectomy
DONOR: A domestic backup unit must be identified and reserved prior to the start of the treatment plan for possible infusion in the unlikely event of poor post-thaw viability of the primary CB unit
Current peripheral neuropathy >= grade 2 or patients with the demyelinating form of Charcot-Marie-Tooth syndrome
Sickle cell disease (SCD)\r\n* If diagnosis of SCD must meet one or more of the following disease characteristics:\r\n** Stroke, central nervous system (CNS) hemorrhage or a neurologic event lasting longer than 24 hours, or abnormal cerebral magnetic resonance imaging (MRI) or cerebral arteriogram or MRI angiographic study and impaired neuropsychological testing\r\n** Acute chest syndrome with a history of recurrent hospitalizations or exchange transfusions\r\n** Recurrent vaso-occlusive pain 3 or more episodes per year for 3 years or more years or recurrent priapism,\r\n** Impaired neuropsychological function and abnormal cerebral MRI scan\r\n** Stage I or II sickle lung disease,\r\n** Sickle nephropathy (moderate or severe proteinuria or a glomerular filtration rate [GFR] 30-50% of the predicted normal value)\r\n** Bilateral proliferative retinopathy and major visual impairment in at least one eye\r\n** Osteonecrosis of multiple joints with documented destructive changes\r\n** Requirement for chronic transfusions\r\n** Red blood cell (RBC) alloimmunization
Other non-malignant hematologic disorders\r\n* Transfusion dependent or involve other potential life-threatening cytopenias, including but not limited to paroxysmal nocturnal hemoglobinuria, Glanzmann’s thrombasthenia, severe congenital neutropenia and Shwachman-Diamond syndrome
Cerebral adrenoleukodystrophy (cALD)\r\n* Diagnosis of adrenoleukodystrophy (ALD) by abnormal plasma very long chain fatty acid (VLCFA) profile or ABCD1 gene mutation\r\n* Cerebral disease on MRI\r\n* Absence of a major functional disability (cortical blindness, loss of communication, wheelchair dependence) on the ALD Neurologic Function Scale\r\n* Performance intelligence quotient (IQ) of 70 or higher
Acute leukemias of ambiguous lineage
Presence of distant metastases; intra-abdominal (regional) spread is allowable if meets inclusion criterial indeterminate or small volume pulmonary nodules may be eligible, if the treating physicians recommend curative-intent resection of the primary tumor despite the presence of possible lung metastases
Prior eribulin
Major operation within 14 days prior to starting study drug or not recovered from surgical complications; neither tumor biopsy nor central line insertion are considered a major operation
Monocytes >= 300/uL
Eligibility of patients receiving any medications or substances known to affect or with the potential to affect the activity or pharmacokinetics of ibrutinib or ability to adhere to the Revlimid REMS program will be determined following review of their case by the principal investigator
Men must have osseous metastases, but the presence of visceral metastases will not exclude patients from participation\r\n* Prior external beam radiation therapy (> 4 weeks prior to enrollment) for palliation of osseous metastatic disease is allowed, provided there is at least one osseous metastasis which has not been irradiated and which can be biopsied
Received systemic therapy with radionuclides (e.g., strontium-89, samarium- 153, rhenium-186, or rhenium-188, or radium Ra 223 dichloride) for the treatment of bony metastases
Ability to swallow epacadostat tablets. In case Incyte at a later time point provides support to administer epacadostat tablets parenterally (via gastrostomy [G]-tube), such administration would also be acceptable as an alternative (once official documentation has been obtained from Incyte)
Ki-67 >= 50%.
Patients with angle-closure glaucoma
Conditions that preclude SGB or sham intervention (e.g., anatomic abnormalities of the anterior neck or cervical spine; goiter, cardiac/pulmonary compromise; acute illness/infection; coagulopathy or bleeding disorder; allergic reactions/contraindications to a local anesthetic or contrast dye); pregnancy
Histologically proven RMS (with fusion status) or undifferentiated sarcoma of the pelvis or abdomen, group 3 (as defined by the IRS, intergroup rhabdomyosarcoma study group staging system seen in addendum 1)
Uncontrolled infection not responding to appropriate antimicrobial treatment after 7 days; study chair is the final arbiter
Mechanical or bioprosthetic heart valve
Automatic implantable cardioverter defibrillator (AICD) placement within the last 30 days
AICD firing within the last 30 days
Patients actively receiving insulin are excluded unless approved by the investigational new drug (IND) medical monitor, IND sponsor, and the study principal investigator (PI)
Patients requiring daily finger-stick blood glucose measurements unless approved by the IND medical monitor, IND sponsor, and the study PI
Patients who are on warfarin and cannot have a drug substitution or who decline the drug substitution
Patients who are on the following drugs and cannot have a drug substitution: flecainide, methadone, amphetamines, quinidine, and chlorpropamide
Receiving potassium wasting diuretics or amphotericin must be noted to have theoretically increased arrhythmia risks with arsenic trioxide (potassium wasting diuretics or amphotericin are not excluded)
Currently taking systemic medications that would affect BCC tumors (oral retinoids) or metabolism of itraconazole (anti convulsants and corticosteroids); itraconazole should not be taken with cisapride (Propulsid), dofetilide (Tikosyn), oral midazolam (Versed), nisoldipine (Sular), pimozide (Orap), quinidine (Quinaglute), triazolam (Halcion), or levomethadyl (Orlaam), lovastatin (Mevacor), simvastatin (Zocor), or an ergot medication such as dihydroergotamine (Migranal), ergometrine or ergonovine (Ergotrate Maleate), ergotamine (Ergomar), or methylergometrine or methylergonovine (Methergine)
Per good clinical practice, any toxicity related to prior therapies that, in the opinion of the investigator, would potentially be worsened with DA-EPOCH-A +/- imatinib (imatinib mesylate) +/- rituximab, should be resolved to grade 1 or less
No other investigational agents, immunomodulating agents, or cancer chemotherapy are permitted for the duration and 12 months following the study IMT unless there is disease progression; radiotherapy is not permitted; appropriate antibiotics, blood products, antiemetics, fluids, electrolytes and general supportive care are to be used as necessary
Patients with extracranial metastases
Sodium 136-146 mEq/L
Bicarbonate 21-31 mEq/L
The presence of diffuse leptomeningeal disease will be an exclusion criterion for this study; this is secondary to the inadequacy of measuring the extent of the tumor burden within this setting and the very poor prognosis of these patients
Prior exposure to eribulin mesylate
AR expression detected by immunohistochemistry by central review
Unable to obtain confirmation of payment coverage (insurance or other) for either possible treatment
Part 2 patients must have recovered from the immediate post-operative period
Part 2 patients must show evidence of wild-type (WT) p53 as assessed by central deoxyribonucleic acid (DNA) sequencing
In case of women, both premenopausal and postmenopausal patients are allowed to be included in study; menopausal status is relevant for the requirement of LHRH agonist (examples for use in this study include but not limited to goserelin, leuprolide or locally available treatment) to be used concomitantly with alpelisib and letrozole/fulvestrant
If on tamoxifen or toremifene with in the past 14 days, plasma estradiol and FSH must be in the premenopausal range per local normal range, or
In case of therapy induced amenorrhea, plasma estradiol and/or FSH must be in the premenopausal range per local normal range
Signs of leukostasis requiring urgent therapy
Participants must be able to adhere to the dosing and visit schedules, and agree to record medication times accurately and consistently in a daily diary
Subjects must have at least 1 cutaneous, subcutaneous, or nodal lesion that is suitable for intralesional injection, with or without the use of ultrasound; lesions in mucosal surfaces (periocular, nasal, etc) are not eligible for injection because the area cannot be properly contained with an occlusive dressing
Subject who is unwilling to minimize exposure with his/her blood or other body fluids to individuals who are at higher risks for human herpesvirus 1 (HSV-1) induced complications such as immunosuppressed individuals, individuals known to have HIV infection, pregnant women, or children under the age of 1 year, during talimogene laherparepvec treatment and through 30 days after the last dose of talimogene laherparepvec
Exposure to household contact with known immunodeficiency
PRRT administered within 6 months of the first dose.
Cryoablation, radiofrequency ablation, or trans-arterial embolization of hepatic metastases
Adenocarcinoma originating in the ampulla or appendix; (duodenal tumors that involve the ampulla but originate in the duodenum are eligible)
Patients with prosthetic heart valves
Refractory congestive heart failure unresponsive to medical treatment, active infection resistant to all antibiotics, or advanced non-MDS associated pulmonary disease requiring >2 liters per minute oxygen.
Pre-study evaluation must include an ophthalmologic exam by an ophthalmologist (not optometrist) and should minimally include visual acuity testing, slit lamp examination, and funduscopic examination; follow up eye-exams will only be performed if subjects develop/report any visual impairment; visual impairment may include peripheral flashes (photopsia), blurred or double vision, floaters, color distortion and dimness, difficulties with light/dark accommodation, tunnel vision or other field defects, halos, apparent movement of stationary objects, and complex disturbances; follow up eye-exams will minimally include visual acuity testing, slit lamp examination, and funduscopic examination; additional testing will be based on symptoms, what is observed and ophthalmologist recommendations
Inability to have fiducial markers placed
Requirement for systemic chemotherapy: all stages except IA (not bulky disease), if involved field is considered radiotherapy (RT) curative
Histologically proven advanced MPM of biphasic or sarcomatoid histology. Biphasic MPM is defined using the World Health Organization's international histological classification of tumors as containing an epithelial and a sarcomatoid component with each component comprising at least 10% of the tumor
Phase 1: Birth through 21 years of age at C1D1 with a locally advanced or metastatic solid tumor or primary CNS tumor that has relapsed, progressed or was nonresponsive to available therapies and for which no standard or available systemic curative therapy exists, or infants from birth and older with a diagnosis of malignancy and with a documented NTRK fusion that has progressed or was nonresponsive to available therapies, and for which no standard or available curative therapy exists, or patients with locally advanced infantile fibrosarcoma who would require, in the opinion of the Investigator, disfiguring surgery or limb amputation to achieve a complete surgical resection. The Phase I dose escalation cohorts are closed to enrollment. In addition to the above stated Inclusion Criteria, patients eligible for enrollment into this cohort must have a malignancy with a documented NTRK gene fusion with the exception of patients with infantile fibrosarcoma, congenital mesoblastic nephroma or secretory breast cancer. Patients with infantile fibrosarcoma, congenital mesoblastic nephroma or secretory breast cancer may enroll into this cohort with documentation of an ETV6 rearrangement by FISH or RT-PCR or a documented NTRK fusion by NGS.
Phase 2 only: Infants from birth and older at C1D1 with a locally advanced or metastatic infantile fibrosarcoma, patients with locally advanced infantile fibrosarcoma who would require, in the opinion of the Investigator, disfiguring surgery or limb amputation to achieve a complete surgical resection or birth through 21 years of age at C1D1 with a locally advanced or metastatic solid tumor or primary CNS tumor that has relapsed, progressed or was nonresponsive to available therapies and for which no standard or available systemic curative therapy exists with a documented NTRK gene fusion (or in the case of infantile fibrosarcoma, congenital medoblastic nephroma or secretory breast cancer with documented ETV6 rearrangement by FISH or RT-PCR or a documented NTRK fusion by NGS) (identified through molecular assays as routinely performed at CLIA or other similarly-certified laboratories) or (including Expansion Phase) potential patients older than 21 years of age with a tumor diagnosis with histology typical of a pediatric patient and an NTRK fusion may be considered for enrollment following discussion between the local site Investigator and the Sponsor's Medical Monitor. Patients with NTRK-fusion positive benign tumors are also eligible.
Patients must have recovered from the immediate post-operative period
Patients who are unwilling to minimize exposure with his/her blood or other body fluids to individuals who are at higher risks for herpes simplex virus (HSV)-1 induced complications such as immunosuppressed individuals, individuals known to have HIV infection, pregnant women, or children under the age of 1 year, during talimogene laherparepvec (T-VEC) treatment and through 30 days after the last dose of talimogene laherparepvec (T-VEC)
AGS67E
L-Histidine
?-trehalose dihydrate or
Phase II temporarily suspended as requested by the FDA due to IND Safety Report of 07 October 2016
oral, intra-vaginal or transdermal combined (estrogen and progestogen containing) hormonal contraception associated with inhibition for ovulation
oral, injectable or implantable progestogen-only hormonal contraception associated with inhibition of ovulation.
vasectomised partner
It is deemed ethical to provide an experimental drug (e.g., Mylotarg) that is associated with hepatotoxicity (veno-occlusive disease [VOD]) and myelosuppression
Willing to avoid household contacts =< 15 months old or household contact with known immunodeficiency 1 week after treatment
Patients who require anti-arrhythmic treatment with Amiodarone or any drug with a quinidine-like effect on the heart or who have history of a malignant ventricular arrhythmia unless they have a functioning Automatic Implantable Cardio Defibrillator (AICD) implanted
Willingness to provide the biologic specimens
Exposure to household contacts =< 15 months old or household contact with a person with known immunodeficiency
Patients with solitary plasmacytoma
Presence of aneurisms of the ascending aorta or aortic stress
Previous treatment with tocilizumab or other cytokine-targeted biologic disease modifying antirheumatic drugs (including adalimumab, certolizumab, etanercept, golimumab, infliximab, anakinra) within 3 months of enrollment
Germline ABCB4 (CC) and ABCB11 (GG or GC) genotypes determined by pharmacogenomics analysis of peripheral blood mononuclear cells
Disease amenable to biopsy via percutaneous approach or other minimally invasive procedures such as thoracoscopy, bronchoscopy, laparoscopy, or gastrointestinal (GI) endoscopy
Patients who are concurrently receiving or requiring any of the following agents, which may increase the risk for mithramycin related toxicities, such as hemorrhage:\r\n* Thrombolytic agents\r\n* Aspirin or salicylate-containing products, which may increase risk of hemorrhage\r\n* Dextran\r\n* Dipyridamole\r\n* Sulfinpyrazone\r\n* Valproic acid\r\n* Clopidogrel
Patients who have the following histologies: mucinous, squamous, sarcomas, carcinosarcomas, clear cell
STAGES 1 AND 2
Multi-organ failure
Hepatobiliary diseases including biliary tract diseases, autoimmune hepatitis, inflammation, fibrosis, cirrhosis of liver caused by viral, alcohol, or genetic reasons; Gilbert’s disease is allowed if TBil is =< 1.5 x ULN
Actively receiving insulin at time of ascorbate infusion (unless an exception is granted by the Investigational New Drug [IND] sponsor, medical monitor, and the principal investigator [PI])
Patients who are on the following drugs and cannot have a drug substitution: flecainide, methadone, amphetamines, quinidine, and chlorpropamide
All patients will be previously or simultaneously enrolled in the natural history ECD protocol #11-HG-0207, “Clinical and Basic Investigations into Erdheim Chester disease”; eligible patients must have been diagnosed with Erdheim Chester disease, confirmed by pathological evaluation of the affected tissue with adequate staining; affected tissue must harbor the BRAF V600E or V600K mutation
Inability to travel to the National Institutes of Health (NIH) Clinical Center
Hyponatremia (serum sodium value less than 130 mEq/L)
While there will be no restrictions on concurrent systemic medications, all subjects must be on a stable immunomodulatory medication regimen for 7 days prior to beginning the study without plans to adjust doses during the following four-week study period; dose modifications to maintain therapeutic drug levels of immunosuppressants (i.e. tacrolimus and sirolimus) during the study intervention period are allowed and do not constitute a trial violation; changes in medications for non-cGVHD medical conditions will not affect eligibility
Refractory to 8- to 12-week course of ESA (erythropoiesis stimulating agent) administered within the past 2 years before enrollment, or erythropoietin (EPO) level ? 500 mU/mL and off ESA for at least 8 weeks before Screening.
Hyponatremia (defined as serum sodium value of < 130 mEq/L).
Up to 2 prior relapses allowed
Myeloproliferative syndromes
A diagnosis of CD established by referring physician(s) and confirmed by our review of the clinical presentation, clinical course, endoscopic and imaging findings, and histology of mucosal tissue specimens
An adverse prognosis, documented by persistent signs and symptoms of CD that have failed to respond satisfactorily to medical and surgical therapies in the past, including but not limited to systemic immune suppressive drugs and biopharmaceuticals; to be considered as refractory to medical and surgical therapy, there must be clinical, endoscopic, and histologic evidence of active inflammatory Crohn's Disease that has either persisted or recurred despite exhaustive treatment with available pharmaceutical and surgical therapies; exhaustive treatment is defined as prior exposure to the following, without durable improvement:\r\n* Systemic glucocorticoids at or above a prednisone equivalent of 40 mg/day for at least 2 weeks, or until drug toxicity or intolerance develops\r\n* Methotrexate (25 mg per week for at least 3 months, or until drug toxicity or intolerance develops) and/or a thiopurine antimetabolite (either 2.5 mg/kg azathioprine or 1.5 mg/kg 6-mercaptopurine in patients homozygous wild-type for the thiopurine-S-methyltransferase [TPMT] gene, or either 1.5 mg/kg azathioprine or 1 mg/kg 6-mercaptopurine in patients heterozygous for TPMT, or doses of these drugs capable of producing a 6-thioguanine nucleotide level of 230-400 without producing a 6-methylmercaptopurine nucleotide level above 5700 for at least 3 months, or until drug allergy, intolerance or toxicity develops); if a patient is homozygous mutant for the TPMT gene, thiopurines would be contraindicated and their use would not be a requirement for enrollment in this protocol\r\n* Use of at least two anti-tumor necrosis factor (TNF)-alpha therapies, that is, infliximab (at least 5 mg/kg every 8 weeks for at least 3 months, or until drug allergy, toxicity or intolerance or anti-infliximab antibodies develop) and/or adalimumab (at least 40 mg subcutaneously [SQ] every 2 weeks for at least 3 months, or until drug allergy, toxicity or intolerance develops) and/or certolizumab pegol (at least 400 mg SQ every 4 weeks for at least 3 months, or until drug allergy, toxicity or intolerance develops)\r\n* Due to the serious risk of progressive multifocal leukoencephalopathy (PML) and the reluctance of some patients to agree to therapy that carries such risk, prior exposure to natalizumab is not required to meet the definition of exhaustive pharmaceutical treatment; neither will use of natalizumab among patients who are John Cunningham (JC) virus antibody seronegative be an exclusionary criterion\r\n* Exhaustive surgical treatment will be defined as indicated operations for complications of Crohn's Disease up to the point where the risks of surgery (for example, mortality or post-operative morbidity such as short bowel syndrome or extensive adhesions with high risk for inadvertent enterotomy) are deemed by patients and their physicians to be unacceptably high; indicated operations for complications of Crohn's Disease include, but are not limited to, surgical resection of involved intestine, stricturoplasty, drainage, curettage, or adhesiolysis of tissues affected by Crohn's disease\r\n* Exposure of patients to investigational drug therapies for Crohn's Disease, that is, to drugs that are not Food and Drug Administration (FDA) approved for this indication, will not be a criterion for either inclusion or exclusion
Endoscopic and histologic evidence of active intestinal inflammation consistent with CD; in the event that the involved mucosa cannot be readily reached by endoscopic biopsy, an imaging test that shows typical changes of CD in the intestinal tract will suffice as evidence of active intestinal inflammation; the presence of intestinal stomas does not exclude the patient from study
A current complication of CD that would jeopardize survival after hematopoietic cell transplantation, including but not limited to the following: \r\n * Abscess, phlegmon, necrotizing skin lesion, or inflammatory fistula\r\n * Intestinal fibrotic stricture and intestinal obstruction\r\n * Uncontrolled mucosal, organ, or systemic infection with a bacterial, viral, fungal, or parasitic organism\r\n * Sclerosing cholangitis
Abnormalities of the cornea based on history (e.g., dry eye syndrome, Sjogren’s syndrome), congenital abnormality (e.g., Fuchs' dystrophy), abnormal slit-lamp examination using a vital dye (e.g., fluorescein, Bengal Rose), and/or an abnormal corneal sensitivity test (Schirmer test or similar tear production test)
Screening urinalysis < 5 white blood cell/high power field (WBC/hpf) (unless alternate urinary diagnosis not consistent with infection)
Gylcated hemoglobin (HgbA1c) < 7.5%
DONOR: Determination of histocompatibility will be made by deoxyribonucleic acid (DNA) oligotyping (low resolution for class I antigens and high resolution for class II antigens)
Within or touching the zone of proximal bronchial tree defined as a volume 2 cm in all directions around the proximal bronchial tree (carina, right and left main bronchi, right and left upper lobe bronchi, intermedius bronchus, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi)
CYP450 3A4 stimulators or inhibitors should be avoided or used with great caution when taking cyclophosphamide; aprepitant should also be used with caution with etoposide or vincristine chemotherapy
Cisplatin should be used with caution with nephrotoxic drug; aminoglycoside should be avoided or used with caution during or shortly after cisplatin administration and concomitant use with amphotericin B should probably also be avoided; patients receiving cisplatin and other potentially ototoxic drugs such as aminoglycoside or loop diuretics concomitantly should be closely monitored for signs of ototoxicity\r\n* Plasma levels of anticonvulsant agents should be monitored and doses adjusted during therapy with cisplatin
Willing to provide biologic specimens as required by the protocol
Exposure to household contacts =< 15 months old or household contact with known immunodeficiency
Prior non-taxane or platinum containing chemotherapy will be allowed if the prior exposure was at least 5 years ago and the exposure is thought not to potentially interact with the primary outcome of the trial or put the patient at undue risk, and should be reviewed with study principle investigator (PI) on a case by case basis
Hemoglobin >= 8.0 (may transfuse)
=< grade 2 hypercalcemia (applicable only for dose levels that include cis retinoic acid [RA])
Patients with a paraben allergy cannot take isotretinoin preparations containing this compound (i.e. Accutane, Sotret) but are eligible if they can take an alternate preparation without paraben; (applicable only for entry onto dose levels receiving isotretinoin)
Patient declines participation in NANT 2004-05; unless the institution has been granted special exemption from mandatory enrollment on NANT 2004-05 by the NANT Operations Center
Prior exposure to FR-targeted therapy (eg, EC145, EC0225, EC0489, farletuzumab).
Inclusion of ECP in the treatment of any patient is contraindicated with any of the following:\r\n* Unstable hemodynamics requiring vasopressors or other support measures not amenable to or medically appropriate for continuation during the procedure\r\n* Uncontrolled infection\r\n* Inability to maintain acceptable venous access\r\n* Uncontrolled or uncorrectable coagulopathy
Patients receiving the following drugs will be clinically evaluated as to whether dosage/medication can be changed to permit patient on study: anti-convulsants (carbamazepine, phenobarbital, phenytoin), anti-mycobacterial (rifabutin), PDE5 inhibitors (sildenafil, vardenafil, tadalafil), HMG-CoA reductase inhibitor (atorvastatin, rosuvastatin), immunosuppressants (cyclosporine, tacrolimus, sirolimus), narcotic analgesic (methadone), oral contraceptive (ethinyl estradiol), macrolide antibiotic (azithromycin), Inhaled/nasal steroid (fluticasone), antidepressant (trazodone)
Patients with other cardiac diseases may be excluded at the discretion of the principal investigator (PI) following consultation with cardiology consultants
For the Diabetes Expansion Cohort - Subjects who currently require insulin,\n             thiazolidinediones, dual proliferator-activated receptors (PPAR) agonists,\n             glucagon-like peptide (GLP-1) analogues, dipeptidyl peptidase (DPP-IV) inhibitors or\n             have received the same in the 4 weeks prior to screening.
Subjects with known complications of diabetes like diabetic nephropathy or diabetic\n             retinopathy
Presence of vestibular schwannomas
Evidence of progressive increase in vestibular schwannoma size or worsening hearing\n             loss due to vestibular schwannoma
Patients must be assigned to S1400B
Patients should be carefully screened for depression at baseline and if there are indications or a history of depression it is strongly recommended that these patients be closely followed together with behavioral health or psychiatric medical support; patients with an established diagnosis of depression that, in the assessment of the investigator may make the administration of interferon (IFN)-alfa or ipilimumab hazardous, should not be enrolled on this protocol; the risks and benefits of being treated with standard adjuvant IFN-alfa should be weighed very carefully in consultation with behavioral health or psychiatry
Patients must not have had any infectious disease vaccination (e.g., standard influenza, H1N1 influenza, pneumococcal, meningococcal, or tetanus toxoid) within 4 weeks prior to randomization
NOTE: Patients who would be excluded from treatment on this protocol strictly for laboratory abnormalities can be included at the principal investigator’s discretion after consultation with the membership of the Texas Children's Cancer Center (TXCCC) Lymphoma Team
Patients with newly diagnosed, biopsy confirmed, extracranial, non-metastatic Ewing sarcoma or primitive neuroectodermal tumor (PNET) of bone or soft tissue are eligible for this study; note:\r\n* For the purpose of this study, chest wall tumors with ipsilateral pleural effusions, ipsilateral positive pleural fluid cytology or ipsilateral pleural based secondary tumor nodules will be considered localized disease\r\n* Patients with regional node involvement, based on clinical suspicion confirmed by pathologic documentation are considered to be non-metastatic\r\n* Patients with discontinuous osseous lesions within the same bone are considered to be non-metastatic\r\n* Tumors arising in the bony skull (extra-dural) are considered to be extracranial
Confirmation of N0 status by frozen section examination; right sided tumors require that node levels 4, 7, and 10 be sampled and diagnosed as negative on frozen section; left sided tumors require that node levels 5 or 6, 7 and 10 be sampled and diagnosed as negative on frozen section; levels 4 and 7 nodes may be sampled by mediastinoscopy, endobronchial ultrasound (EBUS) and/or endoscopic ultrasound (EUS), or at the time of thoracotomy or VATS exploration; nodes previously sampled by mediastinoscopy (or EBUS and/or EUS) either immediately prior to or within 6 weeks of the definitive surgical procedure (thoracotomy or VATS) do not need to be resampled
Hold trimethoprim/sulfamethoxazole (Bactrim) on the day of high-dose methotrexate (HDMTX) infusion and continue to hold until the methotrexate level is less than 0.1 micromolar (1 x 10-7 M)
Avoid IV contrast media, urinary acidifiers, phenytoin, and fosphenytoin on the day of methotrexate and until the methotrexate level is less than 0.1 micromolar (1 x 10-7 M)
There is no limit to the number of prior chemotherapies
Extrahepatic disease
Any contraindications to treatment with LC Bead device (e.g. patients with large diameter arteriovenous shunts or patients with a right-to-left shunt)
Tumor must be HER2-positive and retinoblastoma (RB)-proficient; RB-proficiency is determined by tumor biopsy demonstrating RB normal and cyclin-dependent kinase inhibitor 2A (p16in4a) low by immunohistochemistry; RB proficiency means that there is an intact RB pathway indicative of responsiveness to PD-0332991; RB staining is scored on an absent (no nuclear staining), weak (nuclear staining less than observed in endothelial cells and stromal cells surrounding the tumor), positive (nuclear staining at or above surrounding tissue) (0, 0.5, 1 respectively); p16ink4a is a routine clinical stain that is scored using absent, weak, positive, strong (0, 1, 2, 3 respectively); tumors will be scored using (p16)/(RB), where a score of less than 3 is required for inclusion; RB loss is expected to occur in less than 15% of cases; RB – proficiency will be done locally as standard of care and made available for central review at later time points in the study
Any AIDS-related opportunistic infection occurring within the past year and for which treatment has been unsuccessful would be considered exclusionary, but this is done on a case-by-case basis as determined by the principal investigator
Patients who have adenocarcinomas of the ampulla, distal bile duct, and duodenum
Consensus following presentation of the case at the multidisciplinary Pediatric Neuro-Oncology conference, which includes participation of neuro-oncology, neurosurgery, radiation oncology, interventional neuroradiology and neurology
Patients with lymphomas are excluded
Patients must have histologic or cytologic verification of extra-ocular retinoblastoma; extra-ocular disease includes orbital disease, optic nerve involvement at the surgical margin, regional nodal disease, and/or overt distant metastatic disease (at sites such as bone, bone marrow, liver and/or the central nervous system); patients with trilateral retinoblastoma will also be included in this protocol\r\n* Patients with a CNS lesion consistent with trilateral or stage 4b disease may be enrolled without tissue confirmation if (1) unequivocal leptomeningeal disease is present on brain or spine magnetic resonance imaging (MRI) scan and/or (2) the primary tumor is at least 2 cm in diameter, predominantly solid, and demonstrates enhancement on the post-gadolinium images; however, even in such cases surgery should be given serious consideration
If recent mold infection (e.g. aspergillus) must have minimum of 30 days of therapy and responsive disease and be cleared by infectious disease
Patients must be assigned to S1400D
Subjects with corneal epitheliopathy or any eye disorder that may predispose the subjects to drug-induced corneal epitheliopathy, or may interfere with diagnosis of treatment-emergent corneal epitheliopathy at the discretion of the investigator in consultation with the ophthalmologist/optometrist; low grades of superficial punctate keratitis, within the range seen in the normal population, should not lead to the exclusion of the patient
Patients must be assigned to S1400C
HCV treatment experienced or naive\r\n* HCV treatment naive: no prior exposure to any IFN, ribavirin (RBV), or other approved or experimental HCV-specific direct acting antivirals (DAA)\r\n* HCV treatment-experienced: virologic failure after treatment with polyethylene glycol (PEG)- IFN + RBV, NS3 protease inhibitor plus PEG-IFN + RBV, or regimen of sofosbuvir (SOF) +/- RBV +/- PEG-IFN regimen
Any HCV treatment which uses pegylated interferon
Lymphomas of other histologies other than the ones listed in inclusion above
Documentation of HTLV infection (enzyme linked immunosorbent assay [ELISA]) in individual with confirmation of HTLV-1 infection (by immunoblot or polymerase chain reaction [PCR]) or a consistent clinical picture (including two of the following: 1) CD4+ leukemia or lymphoma, 2) hypercalcemia, and/or 3) Japanese, Caribbean or South American birthplace)
Prior treatment with Xofigo (223Radium), Provenge, mitoxantrone and cabazitaxel is allowed
Patients with a history of cardiac disease are excluded; baseline electrocardiography and assessment of serum troponin (I) are included the screening exams; subjects in whom these assays are abnormal (electrocardiogram [EKG] excluding 1st degree bundle branch block, sinus bradycardia, sinus tachycardia or non-specific T wave changes, serum troponin >= grade 2)
ALL patients who cannot receive any asparaginase products (E. Coli, PEG-asparaginase, or Erwinia asparaginase) on this study (eg, due to prior severe pancreatitis, stroke or other toxicity) are not eligible; patients with clinically significant prior allergies to PEG-asparaginase are eligible if Erwinia L-asparaginase can be substituted
Presence of distance metastases (M1)
Previous urethral sling, artificial urinary sphincter or penile prosthesis surgery
Any AIDS-related opportunistic infection occurring within the past year and for which treatment has been unsuccessful would be considered exclusionary, but this is done on a case-by-case basis as determined by the principal investigator (PI)
AIDS-related syndromes, infectious or otherwise, if perceived to cause excessive risk for morbidity post-HSPC infusion, as determined by the PI; examples include, but not limited to:\r\n* Severe AIDS-related wasting\r\n* Severe intractable diarrhea\r\n* Active inadequately treated opportunistic infection of the central nervous system (CNS)\r\n* Primary CNS lymphoma
Metastases detected below the tentorium or beyond the cranial vault
Patients’ AML must carry mutations in isocitrate dehydrogenase 1 (IDH1) or IDH2
Mammogram or ultrasonography (USG) performed
Significant dermatological disease including but not limited to, skin drying and fissuring, paronychial inflammation, infectious sequelae (eg. blepharitis, cheilitis, cellulitis, cyst)
Clear BCMA expression must be detected on greater than 50% of malignant plasma cells from either bone marrow or a plasmacytoma by flow cytometry or immunohistochemistry; these assays must be performed at the National Institutes of Health; it is not required that the specimen used for BCMA determination comes from a sample that was obtained after the patient’s most recent treatment; BCMA expression will need to be documented on the majority of malignant plasma cells at some time after the original anti-BCMA CAR T-cell infusion in all patients undergoing a second anti-BCMA CAR T-cell infusion; if paraffin embedded unstained samples of bone marrow involved with MM or a plasmacytoma are available, these can be shipped to the National Institutes of Health (NIH) for BCMA staining, otherwise new biopsies will need to be performed for determination of BCMA expression
PHASE II: The patient is participating in the trial at an institutional which has agreed to perform the imaging research studies, completed the American College of Radiation Imaging Network (ACRIN) defined scanner qualification procedures and received ACRIN approval
Diagnosis: \r\n* Patients with refractory or recurrent solid tumors (excluding central nervous system [CNS] tumors) and patients with unresectable translocation positive renal cell carcinoma (tRCC) are eligible; patients must have had histologic verification of malignancy at original diagnosis or relapse\r\n* The diagnosis of translocation morphology or transcription factor E (TFE) renal cell carcinoma is established by having characteristic morphology AND either a) strong nuclear TFE3 or TFEb staining on immunohistochemistry OR b) cytogenetic studies of the tumor demonstrating a TFE translocation OR c) fluorescent in situ hybridization (FISH) demonstrating a TFE translocation
Lack of appropriate caregivers
Significant ST depression of >= 1.5 mm in 2 or more leads and/or T wave inversions in >= 2 leads
Requirement of inotropic support (excluding digoxin)
An adequate number of cryopreserved GD2-CAR cells must be available, or an adequate number of cryopreserved PBMC from the original apheresis must be available to generate a second dose of GD2-CAR T cells; post-GD2 CAR apheresis will not be used to harvest peripheral blood mononuclear cell (PBMC) cells for the transduction for the second infusion
The cell dose (based on CAR transduced cells) for the second infusion shall not be greater than the current dose level completed or the MTD if this has been determined and not less than the first dose level of this study (1 x 10^5/kg)
Patients must be neurologically asymptomatic, or very minimally symptomatic, as judged by the treating physicians
History of sinus or ear surgery, excluding myringotomy or ear tubes
Patients must have progressed on, be ineligible for, or have declined participation in GOG-0254 provided that protocol is actively accruing patients
Prior participation in a randomized controlled study that included MLN9708 (ixazomib) in one of the treatment arms independent of whether assigned to MLN9708 (ixazomib) or not
PROCEEDING TO TREATMENT WITH 5-FC:
Urgent need of treatment to prevent acute neurologic deterioration
Patients currently taking drugs that are generally accepted to have a high risk of causing torsades de pointes including: quinidine, procainamide, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, erythromycins, clarithromycin, chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide, cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine, ranolazine, and St. John’s wort
Patients who have mucinous, squamous, sarcomas, or carcinosarcomas
History of allergic reactions attributed to compounds of similar chemical or biologic composition to MLN8237, including but not limited to established allergic reaction to benzodiazepines, or romidepsin; agents that alter gastric pH may change MLN8237 absorption are not permitted; proton pump inhibitors need to be stopped 4 days prior to the first dose of MLN8237; histamine-2 (H2) receptor antagonists are not permitted from the day prior (day -1) through to the end of MLN8237 dosing; antacid preparations are not permitted for 2 hours before or 2 hours after administration of MLN8237
With active infectious disease requiring deferral of conditioning, as recommended by an infectious disease specialist
Prior DLI is allowed, however not within the 30 days before the 1st dose of ALT-803
Post-transplant lymphoproliferative diseases (often referred to as Epstein-Barr virus [EBV]-associated lymphomas)
Patients with myeloproliferative neoplasms
Patients must have elevated calcitonin levels, greater than 8 pg/mL in females and 16 pg/mL in males
Patients must have autologous transduced activated T-cells with >= 20% expression of GD2
No history of cardiomegaly or bilateral pulmonary infiltrates on chest radiograph or computed tomography (CT); however, patients with cardiomegaly on imaging may be enrolled if they have an assessment of cardiac function (i.e., echocardiography [ECHO] or multi gated acquisition scan [MUGA]) within 3 weeks of starting protocol therapy that is within normal limits; additionally, patients with bilateral pulmonary infiltrates on imaging may be enrolled if the lesions are not consistent with active neuroblastoma (i.e., negative on functional imaging with PET or MIBG, or by pathologic assessment)
Symptomatic disease, as defined by the IWWM, includes the following criteria:\n             Hemoglobin less than 10 g/dL, platelet count less than 100,000 uL, bulky adenopathy\n             or organomegaly, symptomatic hyperviscosity syndrome, severe neuropathy, amyloidosis,\n             cryoglobulinemia, cold agglutinin disease, or evidence of transformation high-grade\n             non-Hodgkin's lymphoma.
Patients on warfarin (patients on injectable blood thinners, such as Lovenox, are able to continue those)
History of any of the following, unless approval is given by the Protocol Chair:\r\n* Heart disease, including acute myocardial infarction\r\n* Cardiac arrhythmias, including sick sinus syndrome\r\n* Pulmonary disease with a known forced expiratory volume (FEV) of < 1.5 or on oxygen\r\n* Gastrointestinal disease, surgery or malabsorption that could potentially impact the absorption of the study drug\r\n* Patients requiring the use of a feeding tube\r\n* Inability to swallow tablets
Due to the possible effect of treatment with ipilimumab on the immunologic response to infectious disease vaccines, patients must not have had any infectious disease vaccination (e.g, standard influenza, H1N1 influenza, pneumococcal, meningococcal, tetanus toxoid) within 4 weeks prior to randomization
Patients must have a complete cytogenetic response (CCyR) OR must have been on nilotinib for a minimum of six months
Total granulocytes of 1000 per mcL or more
Patients with antibiotic allergies per se are not excluded; although the production of TIL for adoptive transfer includes antibiotics, extensive washing after harvest will minimize systemic exposure to antibiotics
Vasopressor requirement
Patients with known antibodies to immunoglobulin (Ig)A
Total granulocytes of 1000 per mcL or more
Patients with antibiotic allergies per se are not excluded; although the production of TIL for adoptive transfer includes antibiotics, extensive washing after harvest will minimize systemic exposure to antibiotics
Patients must have adequate TIL available as described in the Moffitt Cell Therapy Core standard operating procedures (SOP)
Molecular AML-risk group is less-than-favorable as defined by any of the following criteria:            \r\n* The absence of good-risk karyotype t(8;21), inv(16), t(16;16), or t(15;17)identified by metaphase karyotype\r\n* The absence of t(8;21), inv(16), t(16;16), or t(15;17) identified by fluorescent in situ hybridization(FISH)\r\n* The absence of the corresponding fusion transcripts, AML1-eight-twenty-one corepressor (ETO), core-binding factor, beta subunit (CBF?)-smooth muscle myosin heavy chain (SMMHC), or progressive multifocal leukoencephalopathy (PML)-retinoic acid receptor alpha (RARa), identified by reverse transcriptase-polymerase chain reaction (RT-PCR)\r\n* Patient does not have acute promyelocytic leukemia (APL, French-American-British [FAB] M3)
Adequate absolute CD3 count estimated to be required to obtain target cell dose based on discussion with Department of Transfusion Medicine (DTM) apheresis and Cell Processing Section, DTM
Clinically significant oral cGVHD after allogeneic hematopoietic stem cell transplant (HSCT) with severity score of at least 2 on erythema subset and/or at least 1 on ulceration subset and a composite score >= 20 of the OMRS scale confirmed by the principal investigator (PI), clinical study chair (CSC), or lead associate investigator (LAI)
Receiving mitotane within 6 months of enrolling on the study
-
Approval for hydroxychloroquine treatment by an eye doctor, based on a screening eye exam; examples of disqualifying baseline conditions may include macular degeneration and other retinal disease such as cataracts that would interfere with required funduscopic examinations, or severe baseline visual impairment, retinopathy or visual field changes; all patients must undergo a screening eye exam prior to enrollment
Must not have psoriasis or porphyria
Inability to inject medication or test for finger stick glucose
Gall bladder disease or bile duct disease
Granulocytes >= 1,000/uL
Recursive partitioning analysis (RPA) class I (KPS >= 70, primary cancer controlled, age < 65, metastases in brain only) or class II (lack of one or more of class I criteria)
Evidence of tracheoesophageal fistula or invasion into the trachea or major bronchi
All stages of disease
Patients must not have collecting duct or medullary carcinoma
Poorly-controlled DM
** Note: Evidence for MET mutation or amplification is defined as:\r\n*** Positive for c-Met amplification by FISH; or\r\n*** Positive for known c-Met kinase domain activating mutations including V1110L, H1112L, H1112Y, H1124D, M1149T, T1191I, V1206L, L1213V, V1238I, M1268T, P1009S, T1010I, R988C, V941L, but excluding Y1248C, Y1248H, Y1248D, and Y1253D; or\r\n*** Chromosomal translocations that lead to altered transcriptional regulation of c-Met and/or hepatocyte growth factor (HGF) including metastatic alveolar soft part sarcoma, clear cell sarcoma, rhabdomyosarcoma, or translocation associated renal cell carcinoma)
Neutralizing antibodies less than or equal to 75% neutralization of 200 ng/ml of LMB-2
EBV seropositive
EBV-seropositive
OR non-measurable disease only, with rising serum cancer antigen (CA)15-3 or CA 27.29 or carcinoembryonic antigen (CEA) documented by two consecutive measurements taken at least 14 days apart with the most recent measurement being within 42 days prior to registration; the second CA 15-3 or CA 27.29 or CEA value must have at least a 20% increase over the first and for CA 15-3 or CA 27.29 be greater than or equal to 40 units/mL or for CEA be greater than or equal to 4 ng/mL
Patients should be found unresectable by a preliminary Ear, Nose, and Throat (ENT) evaluation or have refused surgery
Presence of third space fluid which cannot be controlled by drainage
Patients with resistant disease (initial or at relapse): those who fail to achieve an objective partial response to three cycles of combination non-cross resistant chemotherapy will be ineligible for transplant in this trial
Previous treatment with or inability to receive BL22 or HA22 recombinant immunotoxin; patients must have had at least 2 prior systemic therapies, including 2 courses of a purine nucleoside analog (PNA), or 1 course of either rituximab or B-RAF proto-oncogene, serine/threonine kinase gene (BRAF) inhibitor following a single prior course of PNA
Serum that neutralizes =< 75% of the activity of 1 ug/mL of LMB-2 using a bioassay
Chronic Epstein-Barr virus (EBV)-associated lymphoproliferative disease\r\n* At any point after diagnosis, including upfront therapy
Serum total bilirubin < 2.5 mg/dl; values above these levels may be accepted, at the discretion of the principal investigator (PI) or lead associate investigator (LAI), if such elevations are thought to be due to liver involvement by malignancy or GVHD
A diagnosis of ET or PV shall be made in accordance with the World Health Organization (WHO) (2008) criteria as shown below (Values below are at the time of diagnosis, not study entry):\r\n* Polycythemia Vera (2 major criteria required)\r\n** Hemoglobin (Hb) > 18.5g/dl (male) or 16.5g/dl (female) or \r\n** Hematocrit (HCT) > 99 percentile reference range or \r\n** Elevated red cell mass (> 25% above mean predicted value) or \r\n** Hb > 17g/dl (male) or 15g/dl (female) if associated with a sustained rise from baseline with no apparent cause (e.g. treated iron deficiency)\r\n** Presence of JAK2V617F\r\n* Essential Thrombocythemia (all 4 major criteria required)\r\n** Platelets count >= 450 x 10^9/L\r\n** Megakaryocyte proliferation with large and mature morphology; no significant increase or left shift of neutrophil granulopoiesis or erythropoiesis\r\n** Not meeting WHO criteria for chronic myelogenous leukemia (CML), PV, myelodysplastic syndromes (MDS) or other myeloid neoplasms\r\n** Demonstration of JAK2V617F, clonal cytogenetic marker or no evidence of reactive thrombocytosis\r\n** May participate in study without presence of JAK2V617F
In addition patients must EITHER be intolerant or resistant to hydroxyurea according to previously modified established criteria as follows:\r\n* Any ONE of the following:\r\n** Platelet count > 600 x 10^9/L after 3 months of at least 2g/day of hydroxyurea or maximally tolerated dose (MTD) of hydroxyurea (2.5 g/day in patients with a body weight greater than 80 kg)\r\n** White blood cell (WBC) < 2.5 x 10^9/L or Hgb < 11g/dl at any dose of hydroxyurea not to exceed 2g/day (for a period of at least 2 months)\r\n** Progressive splenomegaly or hepatomegaly (> 5cm from initiation of hydroxyurea) or the appearance of new splenomegaly or hepatomegaly while on maximum tolerated dose (MTD) of hydroxyurea\r\n** Not achieving a Hct < 45% in order to eliminate the need for supplemental phlebotomies after 3 months of at least 2g/day MTD of hydroxyurea\r\n** Not achieving a WBC of < 10 x 10^9/L after 3 months of at least 2g/day MTD of hydroxyurea\r\n** Having a platelet count < 100 x 10^9/L on hydroxyurea at any dose without eliminating the need for supplemental phlebotomy or having progressive splenomegaly as defined above\r\n** Development of a major thrombotic episode (cerebral vascular accident [CVA], myocardial infarction, severe migraines requiring medication, abdominal vein thrombosis, deep vein thrombosis) while being treated with maximal tolerated doses of hydroxyurea\r\n** Presence of leg ulcers or other unacceptable hydroxyurea-related-nonhematological toxicities, such as unacceptable mucocutaneous manifestations, gastrointestinal symptoms, pneumonitis or fever at any dose of hydroxyurea\r\n* OR have Splanchnic Vein Thrombosis (SVT) (includes Budd-Chiari, abdominal vein thrombosis, portal vein thrombosis, splenic vein thrombosis); for these patients the following additional inclusion/exclusion criteria apply:\r\n** > 3 months since onset of SVT\r\n** SVT treated with oral anticoagulants but no aspirin\r\n** Liver enzymes not > 2 times the normal value\r\n** Absence of encephalopathy, refractory or infected ascites, esophageal varicose of grade > 1 at time of trial entry\r\n** Bone marrow biopsy confirmed diagnosis of PV or ET\r\n** JAK2-V617F present\r\n** These patients may have a normal blood count at trial entry
No detectable PNH (paroxysmal nocturnal hemoglobinuria) clone where tested
Registration of patients who have not yet undergone Oncotype DX screening must occur no later than 56 days after definitive surgery; (for all patients, Step 2 Registration must occur within 84 days after definitive surgery); if the Oncotype DX Breast Cancer Assay has not been performed, patients must be willing to submit tissue samples for testing to determine the Recurrence Score value; a representative block or unstained sections from the representative block are sent directly to Genomic Health for Oncotype DX Breast Cancer Assay which will be performed according to the standard commercial process\r\n* If the Oncotype DX Recurrence Score is already known and is 25 or less, the patient must be registered to Step 2 immediately following Step 1 registration; if the Oncotype DX Recurrence Score is already known and is greater than 25, the patient is ineligible
The Quality of Life and Economic Substudy is permanently closed to accrual effective 12/1/12; patients at U.S. INSTITUTIONS who consent to participate in the Quality of Life and Economic Substudy must agree to complete the S1007 Health-Related Quality of Life Questionnaire: Randomized Study Form after Recurrence Score results and randomized treatment status are known but before treatment has been initiated
Essential Thrombocythemia (all 4 major criteria required)\r\n* Platelets count >= 450 x 10^9/L\r\n* Megakaryocyte proliferation with large and mature morphology; no significant increase or left shift of neutrophil granulopoiesis or erythropoiesis\r\n* Not meeting WHO criteria for chronic myelogenous leukemia (CML), PV, myelodysplastic syndromes (MDS) or other myeloid neoplasms\r\n* Demonstration of clonal cytogenetic marker or no evidence of reactive thrombocytosis\r\n* May participate in study without presence of JAK2V617F
Never treated with cytoreductive drugs except hydroxyurea for up to 3 months maximum (phlebotomy, aspirin allowed, anagrelide allowed)
No known PNH (paroxysmal nocturnal hemoglobinuria) clone
All visible papillary tumors must be resected and those with persistent T1 disease on transurethral resection of bladder tumor (TURBT) should undergo an additional re-TURBT within 14 to 60 days prior to beginning study treatment. Obvious areas of CIS should also be fulgurated.
Available for the whole duration of the study
Patients who cannot hold instillation for 1 hour
cytotoxic agents (e.g. Mitomycin C, doxorubicin and epirubicin) when administered as a single instillation immediately following a TURBT procedure which is permitted between 14 to 60 days prior to beginning study treatment
Known brain/leptomengial involvement of the disease, active neurological disease, dementia
Pathology confirmation of GCT histology at Memorial Sloan-Kettering Cancer Center (MSKCC) or a collaborating treating institution; in exceptional circumstances, patients without pathological diagnosis may be included in the study following discussion with national principal investigator, Dr. Feldman, (or national Co-principal investigator [PI] or MSKCC Co-PI if the national PI is unavailable) if they meet the one of the following criteria:\r\n* Patients with testicular mass (detected clinically and/or by ultrasound), and/or mediastinal or retroperitoneal lymphadenopathy or pineal tumor AND elevated serum tumor markers (human chorionic gonadotropin [HCG] and/or alpha-fetoprotein [AFP]); patients with elevated lactate dehydrogenase (LDH) only will not be included without pathological confirmation of GCT since LDH is a nonspecific marker for GCT and could potentially be elevated in other malignancies such as lymphomas\r\n* Initial treatment without biopsy confirmation is usually recommended and tissue confirmation may be obtained after initiating therapy
Clinically active serious infection documented by positive cultures or an incomplete course of treatment for bacteremia or fungemia
Patients must have been assigned to S1400I
Radiotherapy (RT) (At least 14 days from last local site RT prior to first dose of tazemetostat/At least 21 days from stereotactic radiosurgery prior to first dose of tazemetostat/At least 12 weeks from craniospinal, ? 50% radiation of pelvis, or total body irradiation prior to first dose of tazemetostat)
ATRT
MRT
RTK
Extraskeletal myxoid chondrosarcoma
For subjects with ATRT, MRT, RTK, or selected tumors with rhabdoid features only, the following test results must be available: Morphology and immunophenotypic panel consistent with rhabdoid tumor and loss of INI1 or SMARCA4 confirmed by IHC, or molecular confirmation of tumor bi-allelic INI1 or SMARCA4 loss/mutation when INI1 or SMARCA4 IHC is equivocal or unavailable
For subjects with INI1 negative tumor only, the following test results must be available: Morphology and immunophenotypic panel consistent with INI1-negative tumors, and loss of INI1 confirmed by IHC, or molecular confirmation of tumor bi-allelic INI1 loss/mutation when INI1 IHC is equivocal or unavailable
Extraskeletal myxoid chondrosarcoma
For subjects with ATRT/MRT/RTK only - Has the following test results available: Morphology and immunophenotypic panel consistent with rhabdoid tumor, and loss of INI1 or SMARCA4 confirmed by IHC, or molecular confirmation of tumor bi-allelic INI1 or SMARCA4 loss/mutation when INI1 or SMARCA4 IHC is equivocal or unavailable
Loss of INI1 confirmed by IHC, or
Cytogenetics or FISH and/or molecular confirmation (e.g., deoxyribonucleic acid [DNA] sequencing) of SS18 rearrangement t(X;18)(p11;q11)
A dual-energy X-ray absorptiometry (DEXA) scan must be obtained within 2 years prior to registration
Unmanageable fecal incontinence
In a heterosexually active woman of childbearing potential, unwillingness or inability to use a highly effective contraceptive method for the entire study treatment period and for at least 3 months after study treatment completion. Additionally, for women randomized to chemotherapy, unwillingness to adhere to the restrictions in the respective locally established guidelines and local approved label (prescribing information, Summary of Product Characteristics, or US product insert) from the manufacturer and the Patient Information Leaflet (package insert) as instructed by the Investigator.
Subjects with cholangitis attributed to infectious etiology (e.g., ascending cholangitis, bacterial cholangitis) are eligible if the infection has been fully resolved prior to the screening visit.
Or known cases of drug-induced hepatobiliary toxicities.
Any non-squamous subtype
Each block of chemotherapy is a separate reinduction attempt.
Physiologic dosing of hydrocortisone is permitted.
CIS (with or without papillary disease) OR
Active diverticulitis.
Parts 1 and 3: 0 or 1
Parts 2 and 4: 0, 1, or 2
Radiologic evidence of new and/or progressive parenchymal brain metastasis, spinal cord metastases (intramedullary), or leptomeningeal disease (LMD) by magnetic resonance (MR) imaging of the brain and/or spine, or CSF cytology evidence of new LMD or persistent LMD
Has lactose intolerance.
PMBCL:
RS:
Ocular MEL
A minimum genotypic identical match of 5/10 is required.
They can't cooperate with the special precautions that are needed for this trial.
Key
Discontinuation of all drugs used to treat underlying MF disease at least 7 days prior to baseline visit
Patients of all ages.
Collection of a 5 ml blood sample (red top for serum) from the patient for Ann Arbor Scoring and ready to be shipped immediately after randomization.
Patients must not be registered until receiving confirmation from the Southwest Oncology Group (SWOG) Statistical Center that the patient's tissue specimen was adequate for PD-L1 testing; patients must be registered within 7 working days of receiving the e-mail notification
Patients who received an investigational agent (including AG-120 or AG-221) <14 days prior to their first day of study drug administration. In addition, the first dose of AG-881 should not occur before a period ?5 half-lives of the investigational agent (other than AG-120 or AG-221) has elapsed.
Isolated extra-medullary disease relapse
The following drugs must be stopped > 1 week prior to CTL019 infusion and should not be administered concomitantly or following lymphodepleting chemotherapy: vincristine, 6-mercaptopurine, 6-thioguanine, methotrexate < 25 mg/m2, cytosine arabinoside < 100 mg/m2/day, asparaginase (non-pegylated)
Pegylated-asparaginase must be stopped > 4 weeks prior to CTL019 infusion e. CNS disease prophylaxis:
CNS directed radiation must be completed > 8 weeks prior to CTL019 infusion g. Anti T-cell Antibodies: Administration of any T cell lytic or toxic antibody (e.g. alemtuzumab) within 8 weeks prior to CTL019 is prohibited since residual lytic levels may destroy the infused CTL019 cells and/or prevent their in vivo expansion. If such an agent has been administered within 8 weeks prior to CTL019, contact the Sponsor, consider consultation with an pharmacology expert, and consider measuring residual drug levels, if feasible, prior to CTL019 infusion Women of child-bearing potential (defined as all women physiologically capable of becoming pregnant) and all male participants, unless they are using highly effective methods of contraception for a period of 1 year after the CTL019 infusion. Highly effective contraception methods include:
Discharge summary
Procedure involving Total Mesorectal Excision by an abdominal or transanal approach.
Subject received intra-operative sealant, glue or any buttressing material other than the LifeSeal™ Surgical Sealant.
Excessive bleeding (above 500cc) identified prior to anastomosis formation with the need for intra-operative blood transfusion.
CLINICAL/LABORATORY CRITERIA: Patients must be able to swallow oral medications and must not have a gastro-intestinal disorder with diarrhea as a major symptom or that may alter absorption such as malabsorption syndromes or gastric resection
A score higher than 6 on the Cumulative Illness Rating Scale-Geriatric.
Must have an apheresis product of non-mobilized cells accepted for manufacturing
Associated with symptoms and/or findings; OR
WBCs ? 2000/uL,
For CRC:
Kaposi sarcoma (KS) (following prior KS-specific therapy (Cohorts 1-3)\r\n* (KS) impacting physical and/or psychological wellbeing and not amenable to local therapy and one or more of the following: \r\n** Stable KS despite 6 or more cycles of liposomal doxorubicin or paclitaxel or other active cytotoxic agents (i.e. etoposide, bleomycin, anthracyclines, vincristine [vincristine sulfate], vinblastine); or\r\n** Progressive disease despite 3 or more cycles of liposomal doxorubicin or paclitaxel or other active cytotoxic agents (i.e. etoposide, bleomycin, anthracyclines, vincristine, vinblastine); or\r\n** Patient who received a cumulative lifetime dose of anthracycline of >= 550 mg/m^2; or\r\n** Recurrent or progressive KS after completion of prior first line chemotherapy\r\n** Intolerant of or refuses further cytotoxic chemotherapy\r\n** No KSHV-associated multicentric Castleman disease in past 5 years\r\n** For KS patients, the following laboratory values supersede values below:\r\n*** Platelets > lower limit of normal\r\n*** Hemoglobin > 10 g/dL
Treatment naive Kaposi sarcoma impacting physical and/or psychological wellbeing and not amenable to local therapy. (Cohort 4)\r\n* On antiretroviral therapy (ART) with suppressed HIV viral load for > 3 months (Note: an extended washout period is needed to avoid treatment during the period of risk for the highly toxic and often fatal “Immune Reconstitution Inflammatory Syndrome (IRIS)”\r\n* No KSHV-associated multicentric Castleman disease in past 5 years\r\n* No prior systemic chemotherapy \r\n* No symptomatic pulmonary KS or chest X-rays positive for un-evaluated abnormalities \r\n* Disease evaluable by AIDS Clinical Trial Group (ACTG) KS response criteria\r\n* CD4+ T-cell count >= 100 cells/uL \r\n* For KS patients, the following laboratory values supersede values below:\r\n** Platelets > lower limit of normal\r\n** Hemoglobin > 10 g/dL
Life expectance of greater than two months to allow completion of study treatment and assessment of dose-limiting toxicity
Presence of diffuse leptomeningeal carcinomatosis (focal/localized involvement is acceptable), > 1 cm mid-line shift, uncal herniation or significant hemorrhage/hydrocephalous (small intra-lesional hemorrhage is acceptable); patients with seizure at presentation who have been started on levetiracetam and have been stable for 48 hours prior to study registration are eligible at the discretion of treating physician
Patients with known diagnoses that are associated with germline DDR defects such as Li Fraumeni syndrome and ataxia telangiectasia are excluded from the study
Patients on tacrolimus or any other immunosuppressants with significant interaction with cisplatin
Unstable cardiac disease including angina or hypertension as defined by the need for overnight hospital admission within the last 3 months (90 days).
Chest radiograph
Hematology/biochemistry (as dictated by local hospital practice) should indicate fitness for randomization options and parameters should be in line with considerations specified in the summary of product characteristics; hematological parameters should not be supported by transfusion to enable entry into the trial; liver function and renal function tests must form part of the pre-treatment assessment for patients who may be randomized to receive paclitaxel, ifosfamide, and cisplatin (TIP) chemotherapy e.g. patients with impaired renal function may not be considered for arms B and C of InPACT-neoadjuvant but may be considered for arm A
Pure verrucous carcinoma of the penis
Non-squamous malignancy of the penis
WT TP53 status
For the Monotherapy MET Amplified cohort only: MET amplification by prospective screening assay from peripheral blood; the amplification score must be “strongly positive” (++ or +++), which is defined as amplification present at a level that is observed in the upper 50th percentile of samples with amplifications
Evidence of extensive intraperitoneal adhesions at the time of surgery which prohibits intraperitoneal therapy, as determined by the operating surgeon
Histochemical diagnosis of amyloidosis, as based on tissue specimens with Congo red staining with exhibition of an apple-green birefringence
Must meet criteria for 1 of the following AL Amyloidosis Risk Stages (as defined by N-terminal proBNP [NT-proBNP] cut-off of < 332 pg/mL and troponin T cut-off of 0.035 ng/mL as thresholds):
Stage 3: both NT-proBNP and troponin T over threshold (but NT-proBNP < 8000 pg/mL)
Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR
Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR
Must have baseline efficacy images with measurable target tumors in the liver according to RECIST 1.1 using standard imaging techniques taken within 28 days prior to randomization. Images must be taken after, or at the time of completion of first line chemotherapy
Contraindications to angiography and selective visceral catheterization such as bleeding diathesis or coagulopathy that is not correctable by usual therapy of hemostatic agents
Intervention for, or compromise of, the Ampulla of Vater
Has high risk bone metastases that are asymptomatic or minimally symptomatic (not requiring opioids). High risks metastases are defined as: 1. bulkiest sites of osseous disease >= 2 cm, 2. disease involving the hip (acetabulum, femoral head, femoral neck), shoulder (acromion, glenoid, humeral head), or sacroiliac joints 3. disease in long bones with 1/3-2/3 cortical thickness (humerus, radius, ulna, clavicle, femur, tibia, fibula, metacarpus, phalanges) 4. disease in junctional spine (C7-T1, T12-L1, L5-S1) and/or disease with posterior element involvement
A clinical-pathologic stage - estrogen/grade (CPS-EG) score of ?3, or score 2 if nodal status at surgery is ypN+, calculated using local estrogen receptor status and grade assessed on either core biopsies taken before start of neoadjuvant treatment or surgical specimen (see chapter 21.1).
Granulocytes >= 1,500/uL
No serious, non-healing wounds or ulcers
Non-secretory or oligo-secretory MM
There must be residual disease
Prior intracerebral agent.
Evidence of recent hemorrhage on baseline MRI of the brain. However, patients with clinically asymptomatic presence of hemosiderin, resolving hemorrhagic changes related to surgery, or presence of punctuate hemorrhage in the tumor are eligible.
Used any prescription medication during the prior 2 weeks that the investigator judges is likely to interfere with the study or to pose an additional risk to the patient in participating, specifically inhibitors or inducers of cytochrome P450 (CYP)3A4 (refer to Appendix 5). A stable regimen (? 4 weeks) of antidepressants of the selective serotonin re-uptake inhibitor (SSRI) class is allowed (common SSRIs include escitalopram oxalate, citalopram, fluvoxamine, paroxetine, sertraline, and fluoxetine).
History of urethral and bladder outlet disorders, including urethral stricture disease, urethral diverticulae, bladder neck contracture, urethral fistulae, urethral stenting, urethral sling, urethroplasty or chronic indwelling urethral catheter
Patients with artificial urinary sphincter or any penile implant
Obstructing median lobe enlarged out of proportion to the rest of the prostate and protruding significantly into the bladder, sometimes referred to as \ball valve\ median lobe, determined on Baseline MRI
Patients in the USA: Glucagon
Patients in Canada and Europe: Buscopan (Hyoscine)
Patients must have been assigned to S1400A
Differentiated thyroid carcinoma (DTC) with focus loci of ATC is allowed. If a participant has pathology showing a small focus of ATC arising out of DTC and the measurable disease is not fully consistent with ATC, confirmation of ATC by biopsy is required.
Differentiated thyroid cancer (DTC) or MTC. However, ATC arising out of DTC is allowed, as long as the measurable disease is clinically consistent with ATC i.e., rapidly progressive and/or 18F fluorodeoxyglucose (FDG)-avid.
Are currently totally abstinent (as their preferred and usual lifestyle), and who do not agree to be totally abstinent during the study period and for 30 days after study drug discontinuation.
Valvular heart disease that requires antibiotic prophylaxis for prevention of endocarditis
Receiving monoamine oxidase inhibitor (MAOIs) or a drug which has significant MAOI activity (meperidine, linezolid, methylene blue) within the 21 days before screening
Are at least:
Isolated extra-medullary disease relapse
Anti T-cell therapy: Administration of any T cell or toxic agent is strongly discouraged since residual lytic levels may destroy the infused CTL019 cell or prevent their in vivo expansion.
Solid tumors with documented ROS1, NTRK1, NTRK2, or NTRK3 rearrangement
NSCLC with documented ROS1, NTRK1, NTRK2, or NTRK3 rearrangement
k-RAS wild-type CRC with documented NTRK1, NTRK2, or NTRK3 rearrangement
Other solid tumors with documented ROS1, NTRK1, NTRK2, or NTRK3 rearrangement
For patients enrolled in Part 2SA who are receiving anti-PD-1 mAb therapy, marrow and hepatic function as defined in criteria 8a and 8b may be up to CTCAE Grade 2 if first reviewed, found to be within acceptable safety parameters for treatment with pembrolizumab, and approved by the Sponsor Medical Monitor.
Associated with symptoms and/or findings; OR
Evidence of sphincter invasion on MRI
Confirmed diagnosis of advanced malignancies that may be controlled with p70S6K or Akt inhibition based on already identified molecular alteration known to affect the PAM pathway, such as:: such as: such as: phosphate and tensin homolog (PTEN), phosphoinositide 3-Kinase catalytic subunit alpha isoform (PIK3CA), protein kinase B 1 (Akt 1), Akt 3, mammalian target of rapamycin (mTOR), tumor sclerosis complex 1 (TSC1), tumor sclerosis complex 2 (TSC2), in subjects who have received at least all treatment options considered to be standard therapy, unless some available treatment are not acceptable to the subject. For the dose escalation portion of the trial, subjects must have received the standard therapy unless intolerant or contraindicated.
Monocularity
Contact lens dependent (if using contact lens, must be able to switch to glasses during the entire study duration)
Uncontrolled glaucoma (topical medications allowed)
Uncontrolled or evolving retinopathy, wet macular degeneration, uveitis, papilledema, or optic disc disorder
Have acquired, hereditary or congenital immunodeficiencies including cellular immunodeficiencies, hypogammaglobulinemia and dysgammaglobulinemia.
Prior fenretinide oral capsules is allowed; please consult study chair if prior history of intravenous fenretinide emulsion (allowable if drug stopped due to hypertriglyceridemia); prior 13-cis, 9-cis or all-trans retinoic acid are allowed
Extensive prior RT.
Impending need for immediate RT for symptomatic relief.
Patients managed with a total pancreatectomy, a distal pancreatectomy, or central pancreatectomy
Acute paronychia developing during the course of their monotherapy or combination chemotherapy
Involvement of at least one nail with a Paronychia Severity Grading score of 1 or higher
Individuals who are willing to not start any new products OTC or prescription treatments for Paronychia and discontinue any treatment the investigator feels may interfere with the evaluation of the test products
Individuals who are already on antibiotics as prescribed by oncologist for any condition except paronychia
Individuals who are willing to avoid using cosmetic products, creams, salves, or ointments to the treatment area(s)
Patients with paronychia requiring surgical intervention at baseline
Ineligible for intensification treatment due to failure to mobilize an acceptable number of hematopoietic stem cells
Transformed disease is permitted
At least 14 days for stereotactic radiosurgery
Symptoms due to mass effect of the tumor including high intracranial pressure, marked edema or ?5mm midline shift significant
has achieved menarche at some point
Thrombopoiesis-stimulating agents (eg, romiplostim, eltrombopag, Interleukin-11)
Other investigational mAbs within 6 months prior to first dose of IP.
Serum total bilirubin > 1.5 × ULN. Higher levels are acceptable if these can be attributed to active red blood cell precursor destruction within the bone marrow (ie, ineffective erythropoiesis). Subjects are excluded if there is evidence of autoimmune hemolytic anemia manifested as a corrected reticulocyte count of > 2% with either a positive Coombs' test or over 50% of indirect bilirubin
fevers higher than 100.5°F or 38.0°C for >=2 weeks without other evidence of infection
Active, uncontrolled autoimmune cytopenia. Patients with autoimmune cytopenia which is controlled with corticosteroids at doses of <=20 mg prednisolone or equivalent may be enrolled.
Active hepatitis B or C as evidenced by detection of virus specific Deoxyribonucleic Acid (DNA) or Ribonucleic Acid (RNA).
Has an active infectious process
Anti-nuclear antibody (ANA) negative or low-positive institutional range, as determined within 28 days from registration. Intermediate values (usually defined by a titer of ?1:80, or as indicated by institutional range) are acceptable if there are, in the opinion of the Investigator, no early signs of an autoimmune disease.
Prior administration of other intratumoral immunotherapeutics
PHASE I: History of intolerance to capecitabine at doses =< 1000 mg/m^2 BID, as defined by documented >= grade 3 hand-foot syndrome, documented severe diarrhea requiring hospitalization, or other documented severe adverse events (AEs) attributable to capecitabine
PHASE II: History of intolerance to capecitabine at doses below 1000 mg/m^2 BID, as defined by documented >= grade 3 hand-foot syndrome; documented severe diarrhea requiring hospitalization; or other documented severe AEs attributable to capecitabine
Known presence of osteonecrosis of jaw.
Hypersensitivity reaction to the active pharmaceutical ingredient or any of the capsule components, including Labrasol, butylated hydroxyanisole, and butylated hydroxytoluene;
Patients must not be receiving erythroid stimulating agents (EPO: Procrit, Aranesp)
Site has received notification from Mayo Clinic – Rochester Division of Hematopathology of the central confirmation of diagnosis and tissue adequacy for mandatory research studies
International Prognostic Index (IPI) of 2 or greater
Besylate Sub-Study only: unable or unwilling to eat the FDA recommended high-fat high-calorie breakfast (two eggs fried in butter, two strips of bacon, 4 ounce [oz]) of hash brown potatoes and 8 oz of whole milk) within the recommended 30 minutes.
Tumors must have been completely resected; in patients with tumor adherent to adjacent structures, en bloc R0 resection must be documented in the operative report or otherwise confirmed by the surgeon; near or positive radial margin are NOT exclusions as long as en bloc resection was performed; positive proximal margin or distal margin is an exclusion
Granulocytes >= 1,500/uL
All disease stages
Thymic carcinoid
History and/or current evidence of ectopic mineralization/ calcification including but not limited to the soft tissue, kidneys, intestine, myocard and lung with the exception of calcified lymphnodes and asymptomatic coronary calcification
Current evidence of corneal disorder/ keratopathy incl. but not limited to bullous/ band keratopathy, corneal abrasion, inflammation/ulceration, keratoconjunctivitis etc., confirmed by ophthalmologic examination.
Applies only for patients without the deletion 5q 31.1; patients must have failed treatment with an erythropoietic growth factor, or have a low probability of response to rhu-erythropoietin; patients with low probability of response to rhu-erythropoietin or prior erythropoietin failures are defined as follows:\r\n* Prior erythropoietin failure-requires a minimum trial of >= 40,000 units epoetin alfa/week x 8 weeks or equivalent dose of darbepoetin alfa for 8 weeks with failure to achieve transfusion independence in dependent patients or a failure to achieve a >= 2 g rise in hemoglobin sustained for >= 4 weeks in non-transfusion dependent patients\r\n* Low erythropoietin response profile-rhu-erythropoietin and epoetin alfa-naïve patients receiving >= 2U packed (p)RBC/month for a minimum of 8 weeks, and serum erythropoietin > 500 mU/mL in the 8 weeks prior to randomization for a hemoglobin < 9.5 g/dL
Pretreatment cytogenetics must be performed on all patients; collection of pretreatment specimens must be completed within 28 days prior to registration to S0919; specimens must be submitted to the site’s preferred cytogenetics laboratory
MPD: Patients with polycythemia vera with persistent thrombotic or hemorrhagic complications despite conventional therapy, or who have progressed to postpolycythemic marrow fibrosis
MPD: Patients with essential thrombocythemia with persistent thrombotic or hemorrhagic complications despite conventional therapy, or who have progressed to myelofibrosis
MPD: Chronic idiopathic myelofibrosis with peripheral blood cytopenias
Paroxysmal nocturnal hemoglobinuria (PNH): Patients with the non-aplastic form of PNH (cellular bone marrow) who have had a history of life-threatening complications of their disease including thrombotic events, severe hemolysis or Budd Chiari syndrome are eligible; other patients may be considered following approval at PCC and approval by the Principal investigator
Treated with eculizumab for PNH for at least 6 months prior to Day 1
Gastroduodenal ulcer(s) determined by endoscopy to be active.
Prior formal search was instituted
Patients on anti-platelet agents including clopidogrel and glycoprotein IIb/IIIa inhibitors; aspirin is allowed, but should be held before surgery according to standard practices
Require treatment with any of the exclusionary medications listed in Appendix D.
Patients who previously received BBI608 for treatment of PDAC on the BBI608-118 (BBI608-201PANC) study may continue with BBI608 in monotherapy between discontinuation of the first chemotherapy backbone and start of the second chemotherapy backbone. Patients may begin chemotherapy backbone on a date determined by the investigator and medical monitor for the sponsor after a minimum of 14 days and a maximum of 30 days since last receiving anti-cancer treatment which included BBI608, provided that all treatment-related adverse events have resolved or have been deemed irreversible (except for alopecia).
Known hypersensitivity to the components of the study therapy. (Please reference Section 1, Formulation of EC1169 and EC0652, in the respective Pharmacy Manuals)
Patients receiving QT prolonging medications (such as ondansetron)
Serum cardiac troponin (cTn) level ? 99% percentile of the upper reference limit
Hyponatremia (defined as serum sodium value of < 130 mEq/L).
EXCLUSION FOR COLLECTION OF T CELLS/PBMCS: Females who are pregnant
EXCLUSION FOR TREATMENT: Patients will be excluded if they have isolated extra-medullary relapse of ALL
Patients deemed to have mild hepatic impairment should not be considered for this study; patients with a direct bilirubin level greater than 2.0 mg/dL at screening should be excluded
Sufficient physiological reserves
Patients who have recovered from exploratory thoracotomy
Patients must be offered participation in banking of specimens for future research; with the patient’s consent, specimens (serum and bone marrow biopsy core) must be submitted to the repository; patient consent must be obtained before specimens are submitted
The diagnosis of AML-M3 (acute promyelocytic leukemia) characterized by translocations involving the retinoic acid receptor-alpha (RAR-alpha) gene
Intervention for, or compromise of, the Ampulla of Vater
Patients who meet International Federation of Gynecology and Obstetrics (FIGO) stage I, II, or III criteria for low-risk gestational trophoblastic neoplasia (GTN): post molar GTN or choriocarcinoma (as defined below); patients may have had a second curettage but must still meet GTN criteria below:\r\n* Post molar GTN\r\n** For the purposes of this study, patients must have undergone evacuation of a complete or partial hydatidiform mole and then meet the criteria for GTN defined as:\r\n*** A < 10% decrease in the hCG level using as a reference the first value in the series of 4 values taken over a period of 3 weeks (> 50 mIU/ml minimum) OR\r\n*** A > 20% sustained rise in the hCG taking as a reference the first value in the series of 3 values taken over a period of 2 weeks (> 50 mIU/ml minimum) OR\r\n*** A persistently elevated hCG level a period of 6 months or more following the initial curettage (> 50 mIU/ml minimum)\r\n* Choriocarcinoma\r\n** Histologically proven non-metastatic choriocarcinoma OR\r\n** Histologically proven metastatic choriocarcinoma if the metastatic site(s) is restricted to one (or more) of the following: vagina, parametrium, or lung
Granulocytes >= 1,500/mcL
Patients who do not have GTN
Patients with non-gestational choriocarcinoma
Troponin-T value > 0.4 ng/ml or BNP >300 pg/mL. ° Subjects with baseline troponin-T >Upper Limit of Normal (ULN) or B-type Natriuretic Peptide (BNP) >100 pg/mL are eligible but must have cardiologist evaluation prior to enrollment in the trial for baseline assessment and optimization of cardioprotective therapy.
Plts > 75,000/mcL
Patients with poorly controlled hypertension and on multiple antihypertensives
Known or suspected defect in the function of the urea cycle.
No evidence of a local recurrence in the prostate fossa based on a digital rectal examination (DRE) within 60 days prior to step 1 registration\r\n* Patients with equivocal or questionable DRE findings should have an MRI of the pelvis to exclude the presence of a prostate fossa mass\r\n* Patients with equivocal or questionable exam findings by DRE or MRI are eligible if a biopsy of the lesion is negative for tumor
Histologically-confirmed epithelial or biphasic MPM; biphasic tumors must have a predominantly (?50%) epithelial component
Epstein-Barr virus-associated nasopharyngeal carcinoma basket:\r\n* None
Myopathy > grade 2 or any clinical situation that causes significant and persistent elevation of CPK (> 2.5 × ULN in two different determinations performed one week apart).
Hypersensitivity to dexamethasone, sucrose histidine (as base and hydrochloride salt), and polysorbate 80 or any of the components of study therapy that are not amenable to premedication with steroids, or H2 blockers that would prohibit further treatment with these agents.
Patients with skeletal system symptoms who are already on medications to strengthen bones are allowed if they were started ?28 days before study treatment
cholangiocarcinoma
Corneal epitheliopathy or any eye disorder that may predispose the subjects to drug-induced corneal epitheliopathy, or may interfere with diagnosis of treatment-emergent corneal epitheliopathy at the ophthalmologist's or the investigator's discretion
Poor CYP2D6 metabolizers based on the screening test for genetic polymorphisms in CYP2D6 metabolizing capacity
All Study Arms:
All Arms:
Arms C only: bendamustine
Have adequate biliary drainage.
Requires intermittent or chronic treatment with antiherpetic drugs, except for topical agents
Must have epidural metastasis to be treated with MRI-guided laser ablation
involvement of pterygopalatine fossa, maxillary sinus, or facial skin;.
pterygoid plate erosion;
direct extension to involve prevertebral fascia;
extension to superior nasopharynx or Eustachian tube;
suspected invasion (encasement) of the common or internal carotid arteries. Encasement will be assessed radiographically and will be defined as tumor surrounding the carotid artery 270º or greater;
direct extension to mediastinal structures;
regional metastases to the supraclavicular neck (low level IVB or VB)
If resection occurred at an outside institution, eligibility and treatment MRI evaluations in addition to Rb testing must be completed at CCHMC.
Diffuse Intrinsic Pontine Glioma (DIPG) Patients with newly diagnosed diffuse intrinsic pontine gliomas (DIPGs), defined on neuroimaging as tumors with a pontine epicenter and diffuse intrinsic involvement of the pons, are eligible without histologic confirmation.
Patients with brainstem tumors that do not meet these criteria or not considered to be typical intrinsic pontine gliomas will only be eligible if the tumors are biopsied and proven to have + RB and be the following according to the 2016 World Health Organization classification of tumors of the central nervous system: an anaplastic astrocytoma (IDH mutant, IDH wildtype, or NOS), glioblastoma (IDH mutant, IDH wildtype or NOS), diffuse midline glioma, H3 K27M mutant or H3 K27M negative, diffuse astrocytoma (IDH mutant, IDH wildtype or NOS).
Bi-thalamic tumors, biopsied and noted to have intact RB. Bi-thalamic tumors that are not biopsied will be eligible to enroll on the DIPG/bi-thalamic non-biopsied arm.
Patients must have had histologically verified the following according to the 2016 World Health Organization classification of tumors of the central nervous system: anaplastic astrocytoma (IDH mutant, IDH wildtype, or NOS), glioblastoma multiforme (IDH mutant, IDH wildtype, or NOS), diffuse astrocytoma (IDH mutant, IDH wildtype or NOS)
AND RB positive noted on immunohistochemistry.
QT prolonging drugs with a known risk to induce TdP
Prior systemic radiotherapy with strontium-89, samarium-153, rhenium-186 or rhenium-188.
Ultrasound or CT estimate of prostate volume > 100 grams
CLL/SLL cells must demonstrate one or more of the following high-risk genomic features:\r\n* Del17p13.1(tumor protein p53 [TP53]) as detected by fluorescence in-situ hybridization (FISH)\r\n* Del11q22.3(ataxia telangiectasia mutated [ATM]) as detected by FISH\r\n* Complex karyotype (>= 3 cytogenetic abnormalities on stimulated karyotype)\r\n* Unmutated immunoglobulin variable region heavy chain (IgVH) ( >= 98% sequence homology compared with germline sequence)\r\n* Zeta-chain (TCR) associated protein kinase 70kDa (ZAP-70) gene promoter hypomethylation < 20%
Consented to genome sequencing and database of genotypes and phenotypes (dbGaP)-based data sharing and has provided or will provide germline (peripheral blood mononuclear cell [PBMC]) and tumor DNA/ribonucleic acid (RNA) samples of adequate quality for sequencing; (acquisition of specimens for sequencing and the sequencing itself may be done under this study or as part of routine care or another research project)
A pathologically confirmed (histology or cytology) malignant neoplasm with at least one target lesion that is confirmed by conventional imaging and is determined to express somatostatin receptors by 68Ga-DOTATOC (TATE) PET within 120 days prior to treatment with 90Y-DOTATOC
Completion of Norfolk Quality of Life Questionnaire
Prior PRRT with 90Y-DOTATOC (tyr3-octreotate [TATE]) or 177Lu-DOTATOC (TATE) or 131I-metaiodobenzylguanidine (MIBG) therapy for this malignancy
Any subject for whom, in the opinion of their physician, a 12-hour discontinuation of somatostatin analogue therapy represents a health risk; also subjects who have received long-acting somatostatin analogue in the past 28 days or long-acting lanreotide within the past 16 weeks are excluded; subjects may be maintained on short acting octreotide during the time from last injection of long-acting somatostatin analogue until 12 hours (hrs) prior to injection of study drug; known antibodies to octreotide, lanreotide, or DOTATOC or history of allergic reactions attributed to compounds of similar chemical or biologic composition to 90Y-DOTATOC
Subject weighs more than 450 pounds; (subjects who weigh more than 450 pounds will not be able to fit inside the imaging machines)
B-Leukocyte count ?4.5 x10e9/L
Patients with phaeochromocytoma.
Subjects HCV-positive after successful treatment (defined as sustained virologic response [SVR] 12 or SVR 24) are allowed as long as 4 weeks have passed between completion of HCV therapy and start of study drug
Radical cystectomy has been declined by the patient in a signed special section of the informed consent, whereby there is a clear explanation by the investigator to the subject that a delay of cystectomy may increase his/her chance of disease progression, the results of which may lead to serious and life threatening consequences.
Patients must be able to enter into the study within ten weeks of their most recent diagnostic procedure, which is usually a diagnostic biopsy, a transurethral resection of bladder tumor (TURBT) procedure or positive urine cytology.
Cannot achieve acceptable stereotactic ablative radiation therapy (SABR) planning to meet minimal requirement of target coverage and dose-volume constraints of critical structures
Have baseline clinical and laboratory parameters that are consistent with the requirements prescribed in respective labels and are suitable for consideration of treatment with capecitabine (or 5-FU) and cisplatin (for example, dihydropyrimidine dehydrogenase deficiency).
Patients must be registered within 35 days of completion of chemoradiation
Hereditary complement deficiency
Serum bicarbonate >= 20 mEq/L
In the phase II portion, patients must be newly diagnosed or imatinib treatment naive in the advanced/metastatic setting; prior adjuvant imatinib therapy is allowed as long as disease recurrence was documented >= 90 days after last dose of imatinib and imatinib has not yet been restarted
Active corneal disorder or keratopathy (e.g. corneal abrasion, bullous keratopathy)
Patients must be able to ingest oral medications (crushing and administering via percutaneous endoscopic gastrostomy [PEG] tube is acceptable)
Caution should be taken with the use of hydroxychloroquine and any drugs known to interact with it; it is important to regularly consult a frequently-updated list; medical reference texts such as the Physicians’ Desk Reference may also provide this information
Lipid panel:
body piercing or tattoos,
body piercing or tattoos. At the discretion of the investigator, additional patients may also be tested for hepatitis C.
For patients with LM and/or BM, CNS complications that require urgent neurosurgical intervention
Known intracranial haemorrhage which is unrelated to tumour
Prostate volume by transrectal ultrasonography (TRUS) < 55 cc
All metastases not resected must be amenable to SBRT
The patient must meet ONE of the three following criteria:\r\n* 3-4 radiographically distinct metastases of any distribution in the allowed anatomical sites OR\r\n* 2 radiographically distinct metastases that must be anatomically close (i.e., with less than or equal to 5 cm of normal tissue between them) OR\r\n* 3 or 4 distinct metastasis, 2 or 3 to be treated with SBRT and the other (s) having been surgically removed
Metastases with indistinct borders making targeting not feasible
Patient must have a palpable, superficial tumor, safely accessible for bedside injection that will be radiated and can be accurately localized and stabilized if needed
Patients with Cushing's syndrome due to ectopic ACTH secretion or ACTH-independent (adrenal) Cushing's syndrome.
Agree to consume a standardized vitamin and mineral supplement and avoid other nutrition, dietary, or alternative medications/supplements for the duration of the study
Is intolerant to VELCADE (ie, discontinued due to any adverse event while on VELCADE treatment)
Radiographically documented evidence of major vessel invasion or encasement by cancer.
Paget's disease of the nipple
Hepatitis B or C seropositivity with evidence of ongoing liver damage, which would increase the likelihood of hepatic toxicities from the chemotherapy conditioning regimen and supportive treatments; if there is a positive result in the infectious disease testing that was not previously known, the patient will be referred to their primary physician and/or infectious disease specialist
International prognostic index (IPI) score must be 2-5
Treatment-related mortality (TRM) score =< 6.9 as calculated with simplified model
Has had prior gastrectomy
Patients must have one of the following: elevated beta (b)2-microglobulin levels (defined as 2 times compared to normal), carry a Janus kinase 2 (JAK2) mutation, or presence of phosphorylated p65 nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kB) component in at least 5% of bone marrow cells
Patients with documented c-v-kit Hardy-Zuckerman 4 feline sarcoma viral oncogene homolog (KIT) mutations
Patients currently taking one or more of the following drugs that are generally accepted to have a risk of causing Torsades de Pointes:\r\n* Quinidine, procainamide, disopyramide\r\n* Amiodarone, sotalol, ibutilide, dofetilide\r\n* Erythromycins, clarithromycin\r\n* Chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide\r\n* Cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine
Patients actively receiving insulin are excluded unless approved by the IND medical monitor, the IND sponsor, and the treating radiation oncologist
Patients who are on the following drugs and cannot have a drug substitution: flecainide, methadone, amphetamines, quinidine, and chlorpropamide
Patients with the FIP1L1-PDGFRalpha fusion even with resistance to imatinib (such patients are no longer defined as systemic mastocytosis by the WHO)
Sodium (Na), potassium chloride (K Cl), carbon dioxide (CO2), calcium (Ca), phosphate (PO4) within institutional limits
For the purposes of this study, aggressive multidrug chemotherapy is defined as chemotherapy including 2 or more agents that must include an alkylating agent and a platinum-containing compound; patients must have ONE of the following:\r\n* First episode of recurrent disease following completion of aggressive multi-drug frontline therapy\r\n* First episode of progressive disease during aggressive multi-drug frontline therapy\r\n* Primary resistant/refractory disease (less than partial response by INRC) detected at the conclusion of at least 4 cycles of aggressive multidrug induction chemotherapy on or according to a high-risk neuroblastoma protocol (examples include A3973, ANBL0532, ANBL09P1, etc.)
Platelets >= 100 x 10^9 (SI units 10^9/L)
Concurrent antiviral agent active against vaccinia virus (e.g., cidofovir, vaccinia immunoglobulin) during the study
Clear invasion into the bile duct
History of head trauma, spinal trauma, or other acute trauma with an increased risk of bleeding within 3 months prior to consent.
History of congenital bleeding diathesesor anatomical anomaly that predisposes to hemorrhage (e.g. hemophilia, hereditary hemorrhagic telangiectasia).
Acute pancreatitis where infection has not been documented by a positive blood or abdominal fluid culture or gram stain consistent with bacterial infection.
Currently tolerating imatinib 400mg QD. Patients with prior imatinib treatment interruption or dose reductions are required to be on treatment with 400 mg imatinib for two weeks immediately prior to randomization to ensure tolerance to imatinib
Subjects with less than CHR after 3 months of imatinib treatment or lost CHR after initial achievement
However, if a change in hormonal therapy is indicated, e.g. due to intolerable adverse effects, the regimen may be modified but change should be minimized thereafter.
Ways to minimize risk of DVT should be discussed with patients, including, but not limited to, avoiding smoking, minimizing pro-thrombotic hormone replacement, avoiding prolonged periods of inactivity (e.g. uninterrupted long car or plane trips)
Ways to minimize risk of DVT should be discussed with patients, including, but not limited to, avoiding smoking, minimizing pro-thrombotic hormone replacement, avoiding prolonged periods of inactivity (e.g uninterrupted long car or plane trips)
Patient with low-intermediate risk, early-stage organ-confined prostate cancer (cT1c and cT2a, N0, M0), diagnosed with TRUS guided transperineal biopsy (TPBx) and voluntarily chooses MRgFUS as the non-invasive treatment, who may currently be on watchful waiting or active surveillance and not in need of imminent radical therapy.
Positive TRUS-guided transperineal biopsy (TPBx) cores, detected in a maximum of four (4) sectors, (2 for each cancerous focus) out of 16 sectors (or out of 12 sectors in prostates with volume <20 cc)
No definite evidence of extracapsular extension or seminal invasion by MRI
Lower limb musculo-skeletal fixed deformities.
Active UTI
Prostatitis NIH categories I, II and III
Granulocytes >= 1,500/ml
Patients must not be pregnant or lactating as chemotherapy is thought to present substantial risk to the fetus/infant
Patients with serious non-healing wounds, ulcers, or bone fractures
Subjects must be able to adhere to the dosing and visit schedules, and agree to record medication times accurately and consistently in a daily diary
Patient has a rare hereditary problem of galactose intolerance, severe lactase deficiency or of glucose-galactose malabsorption
Patients with any disease that will obscure toxicity or dangerously alter drug metabolism
Administration of subunit or killed vaccines, such as influenza or pneumococcal vaccine, within two weeks prior to study treatment (day-1) and throughout the study; EXCEPTION - Vaccination for influenza is permitted between week 12 through week 16 and after week 20
Patients receiving any drugs that have potential nephrotoxicity or ototoxicity (such as an aminoglycoside)
Patients will be staged for risk classification and treatment at diagnosis using Children's Oncology Group (COG) staging guidelines
Patients with Gleason score >= 8; PSA > 20; OR clinical stage >= T3 are ineligible for this trial\r\n* Should findings of extracapsular extension or seminal vesicle invasion be noted on prostate MRI, this study, if used, will not render patients ineligible for accrual to this protocol; primary tumor staging for eligibility purposes is to be based on palpable or core biopsy evidence only with respect to extracapsular extension or seminal vesicle involvement
Hepatitis B or C seropositivity with evidence of ongoing liver damage, which would increase the likelihood of hepatic toxicities from the chemotherapy conditioning regimen and supportive treatments; if there is a positive result in the infectious disease testing that was not previously known, the patient will be referred to their primary physician and/or infectious disease specialist
Absence of rectum or other anatomic features which would preclude transperineal needle insertion into the prostate
American Urologic Association Obstructive Symptom Index Score > 24
Subjects with > 1 renal/genitourinary toxicity: \r\n* Bladder spasms\r\n* Creatine > 1.5 x UNL\r\n* Dysuria (painful urination)\r\n* Genitourinary fistula\r\n* Hemoglobinuria (> 1+)\r\n* Operative injury to bladder and/or ureter\r\n* Proteinuria\r\n* Renal failure\r\n* Ureteral obstruction\r\n* Urinary retention\r\n* Urine color change (not related to other dietary or physiologic cause e.g. bilirubin, concentrated urine, hematuria)
Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations
Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, fluocinolone 0.01%, desonide 0.05%, alcometasone dipropionate 0.05%)
Patients with known TP53 mutations or chromosome 17 or 17p deletions
Lymphocytes ? 0.5 x 109/L
SCCHN
Non-resectable disease
Normal LVEF per institutional criteria as determined by either ECHO or MUGA scanning.
Cataract of Grade ?2 for posterior subcapsular cataract, cortical cataract, nuclear opalescence, or nuclear color based on the LOCS III.
Prior treatment with compounds with the same mode of action as proposed for HDM201, i.e. an inhibition of the interaction of TP53 with HDM2, e.g. RG7112 or CGM097
Acquired immunodeficiency syndrome (AIDS) related syndromes or symptoms that may pose an excessive risk for transplantation-related morbidity as determined by the Treatment Review Committee (see Appendix D).
Phase 2: activated B-cell or unclassifiable subtypes confirmed by immunohistochemistry using the Hans algorithm
Fluorodeoxyglucose-avid disease (based on local evaluation) per the Lugano Classification. Fluorodeoxyglucose-avid disease is defined as disease with a 5-point scale score of 4 or 5.
Be of nonchildbearing potential:
Hydroxyurea for ? 14 days
Have abnormal QTcF (>450milliseconds) after electrolytes have been corrected (at least two different ECG readings and at least 15 minutes between readings)
Prior ipilimumab is permitted.
Ongoing treatment with chronic, therapeutic dosing of anti-coagulants.
Ages 2 to 21 at the time of Assent or Consent per IRB guidelines
All patients with a diagnosis of complex atypical hyperplasia OR grade 1 endometrioid endometrial carcinoma on endometrial biopsy or dilation and curettage (D & C) within three months of study enrollment
Congenital or acquired uterine anomaly which distorts the uterine cavity
Genital actinomycosis
Part 1: 0 or 1
Part 2 and 3: 0, 1, or 2
Timing of radiation may be according to a concurrent protocol (such as a Children’s Oncology Group [COG] study) or according to physician discretion
Primary tumor must be arising in one of the following central chest locations:\r\n* Within or touching the zone of the proximal bronchial tree (a volume 2 cm in all directions around the proximal bronchial tree [carina, right (R) & left (L) main bronchi, R & L upper lobe bronchi, intermedius bronchus, R middle lobe bronchus, lingular bronchus, R & L lower lobe bronchi])\r\n* Adjacent to (within 5 mm) or invading the mediastinal pleura\r\n* Adjacent to (within 5 mm) or invading the parietal pericardium
Diagnosis of precursor B-cell or precursor T-cell ALL by immunophenotyping
Electrocardiogram showing no acute ischemic changes
NT-proBNP < 1800 pg/mL
In the dose expansion portion of the phase I study, patients must have locally advanced, unresectable or metastatic GIST that is resistant to imatinib; this population includes patients who have not been treated with imatinib (imatinib naive) but considered to have primary resistance to imatinib, i.e. KIT/PDGFRA wild-type GIST, and patients with imatinib-refractory disease, i.e. has had prior treatment with imatinib
Hepatobiliary diseases including biliary tract diseases, autoimmune hepatitis, inflammation, fibrosis, cirrhosis of liver caused by viral, alcohol, or genetic reasons; Gilbert’s disease is allowed if TBil is =< 1.5 x ULN
Presence of hemosiderin.
Eligibility for T-cell infusion (includes cyclophosphamide, T cell, anti-CTLA4 infusions and s.c. IL-2) (Turnstile 2) (Note: evaluate at least 1 week before T-cell infusion): ECOG/Zubrod performance status of 0-1.
Prior to cyclophosphamide and T cell infusions: platelets =< 50,000
Prior to cyclophosphamide and T cell infusions: bilirubin >=3 x ULN
Inadequate response to eculizumab defined as having received eculizumab for at least 6 months plus a documented LDH level ? 1.5 x the upper limit of normal (ULN) and/or the presence of a known C5 mutation conferring resistance to eculizumab
Investigator considers R-CHOP immunochemotherapy appropriate.
Presence of any condition requiring any form of anticoagulant therapy (heparin flushes for IV catheter are permitted)
Wolff-Parkinson White syndrome or the presence of an intra-cardiac defibrillator
Vaccination with a live or attenuated vaccine =< 28 days prior to randomization; Note: other types of vaccines, including inactivated/killed, toxoid (inactivated toxoid), and subunit/conjugate are all permitted at any time
Patients must have a histologically confirmed diagnosis of primary myelofibrosis (PMF), post-polycythemia vera (post-PV) myelofibrosis (MF), or post-essential thrombocythemia (post-ET) MF using World Health Organization Criteria
Resectable, borderline resectable or metastatic disease
May have had intervening therapy since completion of initial UC-961 dosing, but excluding the following:\r\n* Within 7 days of UC-961 restart, or 5 half-lives (if known), whichever is shorter: small molecular tyrosine kinase inhibitor (e.g.: ibrutinib, idelalisib, AVL-292, IPI-145); \r\n* Within 28 days of UC-961 restart: chemotherapy (e.g., purine analogues, alkylating agents), corticosteroids, radiation therapy, or participation in any other investigational drug treatment (besides UC-961) \r\n* Within 56 days UC-961 restart: previous UC-961 dosing\r\n* Within 56 days of UC-961 restart: monoclonal antibody therapy directed against CLL (eg. rituximab, ofatumumab, obinutuzumab, alemtuzumab)
At time of surgery, has a completed anastomosis that is able to be visualized and is accessible to allow for circumferential sealant application with minimal bowel manipulation (?90%)
Completed anastomosis must be at a location where a WCE can be performed to evaluate for a sub-clinical leak
Open wounds or unhealed fractures within 28 days of starting study treatment
Patients must have a confirmed diagnosis of neurofibromatosis 2 by fulfilling National Institute of Health (NIH) criteria or Manchester criteria, or by detection of a causative mutation in the neurofibromatosis 2 (NF2) gene\r\n* The NIH criteria includes presence of:\r\n** Bilateral vestibular schwannomas, OR\r\n** First-degree relative with NF2 and EITHER unilateral eighth nerve mass OR two of the\r\nfollowing: neurofibroma, meningioma, glioma, schwannoma, juvenile posterior subcapsular lenticular opacity\r\n* The Manchester criteria includes presence of:\r\n** Bilateral vestibular schwannomas, OR\r\n** First-degree relative with NF2 and EITHER unilateral eighth nerve mass OR two of the following: neurofibroma, meningioma, glioma, schwannoma, juvenile posterior subcapsular lenticular opacity, OR\r\n** Unilateral vestibular schwannoma AND any two of: neurofibroma, meningioma, glioma, schwannoma, juvenile posterior subcapsular lenticular opacity, OR\r\n** Multiple meningiomas (two or more) AND unilateral vestibular schwannoma OR any two of: schwannoma, glioma, neurofibroma, cataract
Participants must have progressive or symptomatic meningioma\r\n* NOTE: Histologic confirmation of target meningioma is not required in the setting of compatible radiographic appearance\r\n* NOTE: Progression is defined as an increase in target meningioma volume >= 20% OR >= 3 mm during the past 2 years
other anti-platelet agents (such as clopidogrel, ticlopidine, dipyridamole, or anagrelide).
Have radiologically documented evidence of major blood vessel invasion or encasement by cancer.
Testing of patient’s archived (paraffin embedded, unstained slides) or freshly biopsied tumor nodules must be positive for WT1 protein expression:\r\n* WT1 expression: Immunohistochemical analysis will be performed; WT1 expression will be graded according to an adaptation of the German Immunoreactive Score (IRS); only tumors with moderate to strong IRS scores (4-12) will be considered WT1 positive
At least one metastasis must show uptake of 111In-DTPA-octreotide (indium In-111 pentetreotide) on SPECT that is higher than the physiologic radiotracer uptake by the liver
Non ductal adenocarcinomas, neuroendocrine neoplasms, cystic tumors of the pancreas such as cystadenomas, cystadenocarcinomas and solid pseudopapillary neoplasms; in addition, adenocarcinomas arising from duodenum, distal bile duct, and ampulla will also be excluded
Stable supplement usage for > 2 weeks prior to starting and agrees not to change while on this study
Self-report of regular menstrual cycles >= 6 months (female only)
Unstable psychotropic medications (< 3 months)
All patients with gastroenteropancreatic NETs must have progressed on (or are intolerant of) prior somatostatin analog
Patients with pancreatic NETs must have progressed on (or are intolerant of) either everolimus or sunitinib
CNS complications for whom urgent neurosurgical intervention is indicated (e.g., resection, shunt placement)
Neuroimaging evidence of midline shift
Patients must have negative tests (antibody and/or antigen) for hepatitis viruses B and C unless the result is consistent with prior vaccination or prior infection with full recovery.
have predisposing conditions that are consistent with development of aneurysms of the ascending aorta or aortic stress (for example, family history of aneurysms, Marfan-Syndrome, bicuspid aortic valve, evidence of damage to the large vessels of the heart documented by computed tomography (CT) scan with contrast).
Systemic androgens and estrogens (vaginal estrogen creams are allowed)
Subject has shown a hypersensitivity reaction to the active pharmaceutical ingredient or any of the enzalutamide capsule components, including caprylocaproyl polyoxylglycerides (Labrasol), butylated hydroxyanisole and butylated hydroxytoluene.
Received double-blind placebo during the main study.
The expanded cohort will consist of predominantly (> 50%) p53 mutated HNSCC patients at the MTD
Biliary stents (plastic or metallic) are allowed; however, those patients with metallic stents will not undergo the functional MRI correlative component of this study
Patients with any condition/anomaly that would interfere with the appropriate placement of the IP catheter for study drug administration including: abdominal surgery within 4 weeks of study entry (for reasons other than IP port placement), intestinal dysfunction, or suspected extensive adhesions from prior history or finding at laparoscopy.
Patients who have undergone a diverting tracheostomy which is either a) traversing directly through tumor, b) has been placed for true airway insufficiency; patients with a tracheostomy placed preemptively for impending airway compromise remain eligible for enrollment
No evidence of true progressive disease from the postoperative period to the post-chemoradiation period, based on changes in the neurologic exam, steroid use, or evident radiographic progression, according to RANO criteria; patients with increased or new gadolinium enhancement may continue on protocol if in the investigator’s judgment that enhancement is likely due to pseuodoprogression; the use of correlative imaging studies (including perfusion-weighted imaging [PWI]) and repeat or diffusion weighted imaging (DWI), and repeat imaging after an interval of 2-4 weeks is strongly encouraged to help distinguish between pseudoprogression and true progression
Patients for whom the delivery of APBI is not feasible or any of the dosimetric treatment criteria have not been met
Reduction mammoplasty if 3DCRT or proton APBI are planned
Prior exposure to PM01183
Known myopathy or persistent CPK elevations > 2.5 ULN in two different determinations performed one week apart
Patients with a past history of synchronous endometrial cancer are excluded unless all of the following conditions are met: stage not greater than I-A (International Federation of Gynecology and Obstetrics [FIGO] 2010 staging criteria); no more than superficial myometrial invasion (< 50%), without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serous, clear cell or other FIGO grade 3 lesions, and it has been greater than 3 years since diagnosis and there have been no recurrences
Uncontrolled infection, not responding to appropriate antimicrobial agents after seven days of therapy; the principal investigator (PI) is the final arbiter of eligibility
Bacterial peritonitis within 30 days
Pregnant women and nursing mothers will be eligible for screening only to test HLA type by saliva or buccal swab and WT1 expression from previously collected tissue sample
Meets the criteria for post ET/PV myelofibrosis (MF) as defined by the International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT)
Patients must have a clinicopathological diagnosis of WM (Owen 2003), with symptomatic disease meeting criteria for treatment using consensus panel criteria from the Second International Workshop on WM (Kyle 2003) or serum immunoglobulin M (IgM) > 6000 mg/dL, and measurable disease, defined as presence of immunoglobulin M (IgM) paraprotein with a minimum IgM level of > 2 times the upper limit of normal
Esophagogastroduodenoscopy (EGD) with endoscopic ultrasound (EUS) +/- biopsy at M.D. Anderson are required to confirm staging
Microsatellitosis as per AJCC 2009 definition
Patient has already undergone a local flap reconstruction of the defect after excision of the primary and determination of an accurate excision margin is impossible.
Melanoma located distal to the metacarpophalangeal joint, on the tip of the nose, the eyelids or on the ear, mucous membranes or internal viscera.
Melanoma-related operative procedures not corresponding to criteria described in the protocol.
Serious nonmalignant disease.
A diagnosis of PVNS or GCT-TS (i) that has been histologically confirmed either by a pathologist at the treating institution or a central pathologist, and (ii) where surgical resection would be associated with potentially worsening functional limitation or severe morbidity (locally advanced disease), with morbidity determined consensually by qualified personnel (eg, two surgeons or a multi-disciplinary tumor board).
Symptomatic disease because of active PVNS or GCT-TS, defined as one or more of the following:
a worst stiffness of at least 4 at any time during the week preceding the Screening Visit (based on a scale of 0 to 10, with 10 representing \stiffness as bad as you can imagine\).
Known metastatic PVNS/GCT-TS.
Transformed disease (assessed by investigator):
Patients unable to ambulate or who have amputations or paralysis of any extremity
Study population:
Unstable hyperthyroidism or hypothyroidism
Subjects who have significant urinary obstructive symptoms; American Urological Association (AUA) score must be =< 18 (alpha blockers allowed)
Must have stable disease or disease response as evidenced on CT evaluation a minimum of 28 days and a maximum of 56 days following the completion of chemoradiation
An ECG recorded at screening showing evidence of cardiac ischemia (ST depression of >= 2 mm, measured from isoelectric line to the ST segment); if in any doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not CAD is present
All HIV+ patients will be under the care of an infectious diseases specialist; if a relationship with an infectious diseases specialist is not established, infectious disease specialist will be consulted; records of all viral counts and peripheral T-cell counts must be sent to the study coordinator in order to follow these values over the course of treatment
Endorse persistent CRCI subjective complaints
Has a metastatic deposit that can be biopsied
Histologically documented PCNSL or SCNSL; patients with SCNSL need to have cytology or tissue biopsy documenting lymphomatous involvement of the central nervous system (CNS)
Participants must have a baseline mammographic density >= 25% based upon the Breast Imaging Reporting and Data System (BIRADS) density score of 2, 3, or 4 (2 = 25-50%, “scattered fibroglandular densities”; 3 = 51-75%, “heterogeneously dense breasts”; 4 = > 75%, “extremely dense breasts”); women with a baseline mammographic density of < 25% (1 = 0.-24%, “breasts are almost entirely fat”) will not be eligible
Willingness to abstain from all omega-3 fish oil supplements for 30 days prior to baseline evaluation and during the study intervention
Significant dermatological disease including, but not limited to, skin drying and fissuring, paronychial inflammation, infectious sequelae (eg, blepharitis, cheilitis, cellulitis, cyst); exception: patients with grade =< 2 cetuximab-related rash, xerosis, fissures or paronychial inflammation are eligible
Patients with target tumors that could potentially invade a major vascular structure (e.g., innominate artery, carotid artery), based on unequivocal imaging findings.
Documented BCR-ABL <0.01% (>MR4 i.e. >4 log reduction) or undetectable BCR-ABL by PCR for at least 2 years according to the patient's local lab
Documented BCR-ABL <0.01% (>MR4 i.e. >4 log reduction) or undetectable BCR-ABL at least 3 times prior to screening according to the patient's local lab
Has been on any number of TKIs, but has not been resistant to any TKI (changes made for intolerance are allowed)
Patients are allowed to have received prior treatment with mFOLFOX6; if patients are currently receiving treatment with mFOLFOX6, the subject must have documented disease progression; patients must also be able to tolerate standard mFOLFOX6; reduced dosing of mFOLFOX6 at enrollment is exclusionary
Total Cumulative Illness Rating Scale (CIRS score) greater than (>) 6
An individual organ/ system impairment score of 4 as assessed by the CIRS definition limiting the ability to receive the treatment regimen of this trial with the exception of eyes, ears, nose, throat organ system
A platelet count of at least 100,000/mm^3 on at least 2 consecutive blood draws at least 1 week apart with results stable or trending upward is required
Pathologically confirmed MCL, with documentation of monoclonal B cells that have a chromosome translocation t(11;14)(q13;q32) and/or overexpress cyclin D1.
CTCL with histologic evidence of folliculotropic variant or large cell transformed CTCL
Circulating atypical cells of clinical significance
The QTc should be based on single or averaged QTc values of triplicate ECGs obtained over a brief recording period.
Confirmed PD-L1-positive SCCHN by Ventana SP263 assay
Received systemic therapy with radionuclides (e.g., strontium-89, samarium-153, rhenium-186, or rhenium-188, or radium Ra 223 dichloride) for the treatment of bony metastases
Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR
Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR
AGS67E
L-Histidine
?-trehalose dihydrate or
Serum alkaline phosphatase less than 2.5 times the upper limits of normal; note: if hepatic function is abnormal, the decision to initiate temozolomide treatment should carefully consider the benefits and risks for the individual patient
Patients who are on the following drugs and cannot have a drug substitution: flecainide, methadone, amphetamines, quinidine, and chlorpropamide; note: high dose ascorbic acid may affect urine acidification and, as a result, may affect clearance rates of these drugs
This must be the patient’s FIRST mobilization attempt
Willing to allow blood collections; and capable of performing a simple test for assessing cardiopulmonary fitness
Plans to relocate from area within the next year
Patients must have an intraperitoneal (IP) port in place; if a patient does not have an IP port, she must be willing to undergo surgical placement of one
Patients with known macular degeneration or uncontrolled glaucoma
For bilateral retinoblastoma\r\n* Group A and Group A eyes that have failed local therapy\r\n* Group A and Group B eyes that have failed local therapy\r\n* Group A and Group C eyes\r\n* Group A and Group D eyes\r\n* Group A and Group E eyes in which the Group E eye is not planned for enucleation after first cycle of chemotherapy\r\n* Group B and Group B eyes that have failed local therapy\r\n* Group B and Group C eyes\r\n* Group B and Group D eyes\r\n* Group B and Group E eyes in which the Group E eye is not planned for enucleation after first cycle of chemotherapy\r\n* Group C and Group C eyes\r\n* Group C and Group D eyes\r\n* Group C and Group E eyes even if early enucleation is planned for the Group E eye\r\n* Group D and Group D eyes\r\n* Group D and Group E eyes even if early enucleation is planned for the Group E eye\r\n* Group E and Group E eyes if at least one eye is not planned for enucleation
Eyes with tumors that are amenable to local therapy with laser or cryotherapy without threat to vision
Any technical factor that would prohibit use of catheterization of the ophthalmic artery (e.g., small for age infant, untreatable allergy to contrast)
Abnormal cerebral vasculature noted on magnetic resonance (MR) angiography that would increase the risk of the procedure, including but not limited to an incomplete circle of Willis; other abnormalities that are less severe than an incomplete circle of Willis will be reviewed by the study chair in consultation with a neuro-interventional radiologist
Patients with phaeochromocytoma
Asymptomatic or minimally symptomatic
Lymphocytes >= 0.3 x 10^9/L
Monocytes >= 0.25 x 10^9/L
Requirement for RBC transfusion while on ruxolitinib treatment, OR
Dose adjustment of ruxolitinib to < 20 mg twice daily at start of or during ruxolitinib treatment AND at least one of the following while on ruxolitinib treatment:
Subjects with a known hypersensitivity to protocol systemic chemotherapy that was life-threatening, required hospitalization or prolongation of existing hospitalization, or resulted in persistent or significant disability or incapacity
Patient's tumour sample must be PD-L1 positive (?25%of tumour cells with membrane staining (Cohort 1 and 2) or PD-L1 positive with ?90% of tumour cells with membrane staining (Cohort 3))
Unable to draw labs for HDMTX serum concentration
Patients with Trisomy 21
Subject must have available at least 3 prior full sets of scans (not including screening), each separated by at least 2 months with less than or equal to 5 mm slice thickness and up to 1 mm interslice gap on either 2D T2 weighted image, 3D T2 weighted image, or FLAIR.
Subjects taking the following sensitive cytochrome P450 (CYP) 3A4 substrate medications are excluded from the study unless they can be transferred to other medications prior to enrolling: alfentanil, aprepitant, budesonide, buspirone, conivaptan, darifenacin, darunavir, dronedarone, eletriptan, eplerenone, felodipine, indinavir, fluticasone, lopinavir, lovastatin, lurasidone, maraviroc, midazolam, nisoldipine, quetiapine, saquinavir, sildenafil, simvastatin, tolvaptan, tipranavir, triazolam, ticagrelor, vardenafil and/or the CYP2B6 substrates: bupropion, efavirenz.
Patients must have confirmation of DT/DF by local pathologist prior to registration
Chronic daily NSAID use as treatment for controlling desmoid tumors is not allowed, and should be stopped >= 3 days prior to registration; NSAIDS are allowed when used for desmoid tumor-related pain or for symptoms that are unrelated to desmoid disease (eg. headache, arthritis)
Patient has documented evidence of PrR negative endometrial cancer. PrR negativity can be determined by immunohistochemistry. The tumor is considered PrR negative if the number of PrR positive cells is less than 1% determined by immunohistochemistry;
Carcinoid with hormone related symptoms
The need for treatment with medications with clinically-relevant metabolism by the cytochrome P450 (CYP) 3A4 isoenzyme within 3 hours before or after administration of SNX-5422
Able to swallow thin liquids or have a feeding tube for delivery of nutrition
Patients must have adequate EGFR greater than 30 mL/min per 1.73 m2 (per VA formula and adjusted for gender and race)
No clinical evidence of uncontrolled active infectious process
Sarcoma located on upper (includes shoulder) or lower (includes hip) extremities or on body wall
Radiosurgery including Gamma Knife, linear accelerator based radiosurgery, CyberKnife and placement of Gliadel wafer
Morning cortisol >= institutional normal
Known castration-resistant disease
Need for any of the medications on the list of drugs to be used with caution or to be avoided
Melan-A (MART) 1 or solute carrier family 45, member 2 (SLC45A2) (+) staining results; (if patients have not had staining test in the past, the test will be run after patient consent is obtained, but before enrollment)
Ongoing participation in a Phase 2 (LX1606.1-202-CS, LX1606.1-203-CS) or Phase 3 (LX1606.1-301-CS, LX1606.1-303-CS) study
Major protocol violations or tolerability concerns in a Phase 2 (eg, LX1606.1-202-CS, LX1606.1-203-CS) or Phase 3 (eg, LX1606.1-301-CS, LX1606.1-303-CS) study
Willing to take AA on an empty stomach; no food should be consumed at least two hours before and for at least one hour after the dose AA is taken
Cholangiocarcinoma for which treatment with FOLFOX6 or CAPOX would be acceptable as determined by the Investigator.
Abnormal glucuronidation of bilirubin
Castration-resistant disease defined as:
Have some types of eye problems or impairments
With historically documented Ph+ cells
Refractory to ofatumumab (progression or relapse <12 months of receiving ofatumumab therapy or <24 months of receiving an ofatumumab- containing regimen)
Prior exposure to oprozomib
Must have measurable levels of myeloma paraprotein in serum (? 0.5 g/dL) or urine (? 0.2 g/24 hours)
Patients with active inflammatory processes including T max > 101 or active tissue inflammation are excluded
Prior exposure to plerixafor
Subject has shown a hypersensitivity reaction to the active pharmaceutical ingredient or any of the capsule components, including Labrasol, butylated hydroxyanisole, and butylated hydroxytoluene.
Uric acid within University of Iowa Hospital and Clinics (UIHC) normal institutional limits; medical therapy may be used to achieve this targeted range; must be within limits (2.4 – 7.0 mg/dL) prior to starting diet
Information available or pending regarding possible genetic alterations that can explain the patient’s pheochromocytoma/paraganglioma (mutations in succinate dehydrogenase subunit B [SDHB], SDHV or von Hippel-Lindau [VHL] genes)
Prior therapeutic MIBG is allowed
Patients with pheochromocytoma/paraganglioma tumors potentially curable by surgical excision alone as determined by the Principal Investigator in discussions with the surgical consultants
Patients who have large abdominal masses impinging on bowel or pulmonary masses with encroached vessels and a potential to bleed will be considered on case by case basis after careful consultation with multiple disciplines such as radiologists and surgeons with main intent being patient safety
Minimum weight 20 kilograms is required to be eligible for the study since the minimum injection volume of SYLATRON is 0.05 ml, 20 mcg, subcutaneously (SQ) as suggested by Merck
Patients must have evidence of radiographic progression as defined below:\r\n* Stratum 1: defined as >= 25% increase in the product of the greatest perpendicular diameters of the tumor as a whole (solid and cystic component) AND >= 0.4 cm increase in each of at least two dimensions of the tumor as a whole OR any new or worsening neurologic/vision deficit in conjunction with a lesser change in the solid or cystic component\r\n* Stratum 2: \r\n** For patients more than 6 months following radiation therapy (RT) (including radiosurgery or P32), progression is defined as a >= 25% increase in the product of the greatest perpendicular diameters of the solid component AND >= 0.4 cm increase in each of at least two dimensions of the solid component\r\n** For patients more than 12 months following RT (including radiosurgery or P32), progression is defined as >= 25% increase in each of the product of the greatest perpendicular diameters of the solid tumor AND >= 0.4 cm increase in each of at least two dimensions of the solid tumor; patients demonstrating predominantly cystic progression more than 12 months after RT must show a continued increase in the cystic component on two serial MRI scans performed at least 4 weeks apart OR re-accumulation of the cyst following one or more cyst aspirations; patients with progressive neurologic signs and/or symptoms associated with isolated cyst formation or progression are eligible if the neurologic signs and/or symptoms do not improve within 4 weeks of cyst aspiration
Patients with a recognized acquired, hereditary, or congenital immunodeficiency disease including cellular immunodeficiency’s, hypogammaglobulinemia or dysgammaglobulinemia
Patients receiving the following drugs that are contraindicated with nelfinavir (NFV) (VIRACEPT) will be excluded if they cannot be change or discontinued; drugs that should not be coadministered with Viracept:\r\n* Antiarrhythmics: amiodarone, quinidine\r\n* Antimycobacterial: rifampin\r\n* Ergot derivatives: dihydroergotamine, ergonovine, ergotamine, methylergonovine\r\n* Herbal products: St. John's wort (hypericum perforatum)\r\n* 3-hydroxy-3-methyl-glutaryl (HMG)-acetyl coenzyme A (CoA) reductase inhibitors: lovastatin, simvastatin\r\n* Neuroleptic: pimozide\r\n* Sedative/hypnotics: midazolam, triazolam
Patients receiving the following drugs will be clinically evaluated as to whether dosage/medication can be changed to permit patient on study: \r\n* Anti-convulsants: carbamazepine, phenobarbital\r\n* Anti-convulsant: phenytoin; phenytoin plasma/serum concentrations should be monitored; phenytoin dose may require adjustment to compensate for altered phenytoin concentration\r\n* Anti-mycobacterial: rifabutin; it is recommended that the dose of rifabutin be reduced to one-half the usual dose when administered with VIRACEPT; 1250 mg BID is the preferred dose of VIRACEPT when coadministered with rifabutin\r\n* Erectile dysfunction agent: sildenafil; sildenafil shall not exceed a maximum single dose of 25 mg in a 48 hour period\r\n* HMG-CoA reductase inhibitor: atorvastatin; use lowest possible dose of atorvastatin with careful monitoring, or consider other HMG-CoA reductase inhibitors such as pravastatin or fluvastatin in combination with VIRACEPT\r\n* Immunosuppressants: cyclosporine, tacrolimus, sirolimus\r\n* Narcotic analgesic: methadone; dosage of methadone may need to be increased when coadministered with VIRACEPT\r\n* Oral contraceptive: ethinyl estradiol; alternative or additional contraceptive measures should be used when oral contraceptives and VIRACEPT are coadministered\r\n* Macrolide antibiotic: azithromycin; dose adjustment of azithromycin is not recommended, but close monitoring for known side effects such as liver enzyme abnormalities and hearing impairment is warranted
The target index tumor(s) is determined (by CT images) to be in a location where cryoablation is technically achievable based on the proximity of adjacent organs/ structures and is greater than 0.5 cm from any critical organ/structure (possibly achieved with additional maneuvers such as iatrogenic pneumothorax or hydrodissection).
BCC/SCC in region adjacent to or overlapping with region of prior radiotherapy
BCC/SCC on irregular surface (i.e., target area not flat)
BCC/SCC adjacent to or overlapping with burn or scar
BCC/SCC in area prone to trauma (including, but not limited to the skin overlying the tibia, dorsum of hands and elbow)
BCC/SCC in area with compromised lymphatic drainage or vascular supply
BCC/SCC within 3 cm of another treated or untreated BCC/SCC
Receipt of drug that will affect biologic response to radiation (radiosensitizer or radioprotector)
Columbia Suicide Severity Rating Scale (C-SRSS) baseline/screening: patient response of “yes” to any question except question 1
Patient must have a medical oncology consult with the recommendation of chemotherapy; recommended regimens are as follows: cyclophosphamide and doxorubicin (AC); Taxotere, doxorubicin and cyclophosphamide (TAC); Taxotere and cyclophosphamide (TC); or Taxotere, carboplatin and trastuzumab (TCH) prior to registration; the use of additional chemotherapy, hormonal therapy or trastuzumab after the initial regimen is at the discretion of the medical oncologist; other primary regimens are possible but the principal investigator (PI) must be notified prior to enrollment
No lymphovascular space invasion (LVSI) present on biopsy or previous cone
Presence of LVSI
Intrathoracic disease should be encompassable in acceptable radiation fields per investigator clinical judgement.
Prior lenvatinib
Patients who have borderline resectable disease using National Comprehensive Cancer Network (NCCN) definition
Key
Treatment with T-cell depleting, B-cell depleting or IL-2 signaling targeted medication (eg, ATG, alemtuzumab, basiliximab, denileukin diftitox, IL-2, rituximab within 12wks prior to starting AMG 592.
Treatment with T regulatory cell expanding therapies (ie ECP, PUVA, UVB, adoptively transferred T regulatory cells) within 4 wks prior to starting dose of AMG 592.
Laparotomy incisions unable to be closed primarily due to tissue or fascial damage
Transverse laparotomy incisions
Laparotomy incisions left open due to a case classification as “contaminated” or “dirty”
GVHD therapies such as calcineurin inhibitors, methotrexate or other chemotherapeutics, mycophenolate mofetil, rapamycin, or immunosuppressive antibodies (such as anti-tumor necrosis factor-? [TNF?], anti-interleukin-6 [IL-6], or anti-interleukin-6 receptor [IL 6R]) within 4 weeks prior to leukapheresis
tenosynovial giant cell tumor (TGCT), which is associated with severe morbidity or functional limitations and for whom surgery is not an option (prior pexidartinib is permitted for TGCT patients unless ineffective or not tolerated and there has been a washout period of at least 4 weeks)
intra-uterine device (nonhormonal or hormonal)
Patients have CTC >= 3
Granulocytes >= 1,500/uL
Symptomatic local or regional disease requiring medical intervention
No clinical ileus or subileus
Self-reported race of either African American or Caucasian
Have access via central line (e.g., portacath)-double lumen due to CPI-613 administration requirements
Patient must have failed prior chemoradiation with temozolomide and any other therapies except BEV (group A), or must have failed primary chemoradiation and a BEV-incorporating treatment (group B)
Patients must be greater than 12 weeks following completion of chemoradiation or any additional radiation to reduce the chance of pseudoprogression
Patients must not have any disease that will obscure toxicity or dangerously alter drug metabolism
PSA value that is undetectable can be enrolled if pathology from prostatectomy demonstrates one or more of the following: positive margin, extracapsular extension, or seminal vesicle invasion
Normal functioning of daily living activities
Treatment with clinically significant cytochromes P450 enzyme inducers, such as phenytoin, phenobarbital, chlordiazepoxide, diazepam, isoniazid, metronidazole, warfarin, amitriptyline within 14 days prior to the first dose of disulfiram; of note, lorazepam and oxazepam are not affected by the P450 system and are not contraindicated with disulfiram
Patients must be willing to submit blood for pharmacokinetics; sites must order S1221 pharmacokinetic (PK) kit immediately after registration; the Southwest Oncology Group (SWOG) patient identification (ID) number must be provided on the S1221 PK Kit request form
Any prior intervention for, or ongoing compromise of, the ampulla of Vater or biliary-enteric anastomosis
Patients must not have evidence of extensive or “matted/fixed” pathologic adenopathy on preoperative imaging
Pregnant or breast-feeding because there are no adequate and well-controlled studies of eltrombopag use in pregnancy and it is unknown whether eltrombopag is excreted in human milk.
Infratentorial meningioma (patients may have infratentorial meningioma if there is concurrent growing supratentorial meningioma that serves as the target lesion)
Skull defect with missing bone
Presence of a foreign body intracranially such as a bullet fragment
Patients who are pregnant or breast-feeding; the anti-proliferative activity of this experimental drug may be harmful to the developing fetus or nursing infant
Patients must have completed all planned/elective surgeries > 4 weeks and must have recovered from surgery before registration; participants should try to avoid any additional elective surgeries during the study period; particular instances may be discussed with Protocol Chair/designee
History of toxicity to the most recent AI (letrozole or exemestane) that warrants cessation of the AI
All patients must have a baseline Mini Mental Status Examination score >= 21
Patients with gliomatosis will be excluded
Patients weighing greater than 136 kilograms will be excluded
Disease must be technically amenable to transhepatic arterial chemoembolization (TACE), radiofrequency ablation (RFA), or cryoablation; each case will be discussed at gastrointestinal (GI) tumor board with interventional radiology; patients must have evaluable disease
Patients with unhealed surgical wounds for more than 30 days
More than 2 prior relapses
Granulocytes >= 1,500/mcL
Patients with baseline troponin levels greater than the institutional limit of normal
Use of investigational agents/any anticancer therapy within 2 weeks before study entry with the exception of hydroxyurea (NOTE: for patients with hyperleukocytosis [white blood cell (WBC) > 20,000/uL], hydroxyurea [and leukapheresis, if clinically indicated] will be initiated and these patients will receive 5-azacytidine when the WBC count has decreased to =< 20,000/uL; hydroxyurea can be overlapped with 5-azacytidine in selected cases, after consultation with the study chair; hydroxyurea must be discontinued before the initiation of the HiDAC/mitoxantrone chemotherapy)
Gastroduodenal artery encasement up to the hepatic artery with either short segment encasement or direct abutment of the hepatic artery without extension to the celiac axis.
Tumor abutment of the SMA not to exceed greater than 180 degrees of the circumference of the vessel wall.
Tail: SMA or celiac encasement greater than 180 degrees.
Nasopharyngeal, salivary gland, lip or sinonasal carcinoma
Prior oprozomib exposure
Must meet one of the following three criteria\r\n* < 100 cigarettes smoked lifetime\r\n* Known to harbor a RET rearrangement; importantly, at least 3 patients out of the first 18 and 6 patients overall must harbor RET rearrangements in their lung cancers (note that screening for RET rearrangements will not be done as part of this study and must be done separately, prior to screening)\r\n* Known to harbor another potentially targetable genomic alteration in RET, cKIT, PDGFRa, or PDGFRb; eligible genomic alterations include rearrangements, high level amplifications, insertions or deletions in the kinase domain, or point mutations that are known to be oncogenic
Subjects with a hypersensitivity to halichondrin B or halichondrin B chemical derivative
Patients who are unable to return for follow-up visits as required by this study; patients with a history of second malignant tumor, other than the common skin cancers - basal and squamous carcinomas, within the past 3 years and uncertainty about the histological nature of the metastatic lesions; cases with other types of malignancies should be reviewed and decided by the principal investigator (PI) of the study
Patients cannot be already treated on angiotensin-converting enzyme inhibitor (ACE) or angiotensin II receptor blocker (ARB) therapy for hypertension or renal protection (with diabetes) at the time of enrollment
Clinical stage IIA (T2N0), IIB (T2N1, T3N0) or stage IIIA (T1N2, T2N2, T3N1, T3N2), IIIB, or IIIC breast cancer with no prior treatment
Inability to swallow BKM120 capsules; (in the future a different formulation of BKM120 may become available and may be approved by Novartis for other routes of administration, which would then supersede this exclusion criteria)
Patients who have hypoglycemia with a value of =< 50 mg/dL
Known HIV-positive patients and those with other acquired/inherited immunodeficiencies are ineligible due to the possibility of affecting the response to indoximod and the higher risk of active opportunistic infections.
Granulocytes >= 1,500/mcL
Group 7: Patients with ERK mutated cancer
Barcelona Clinic Liver Cancer stage Category B or C that cannot benefit from treatments of established efficacy with higher priority such as resection, local ablation, chemoembolization or systemic sorafenib.
Colon wall involvement
Inability to avoid exposure of skin or eyes to direct sunlight or bright indoor light for at least 30 days
Porphyria
Patients must have a confirmed diagnosis of neurofibromatosis 2 by fulfilling National Institute of Health (NIH) criteria or Manchester criteria, or by detection of a causative mutation in the NF2 gene\r\n* The NIH criteria includes presence of:\r\n** Bilateral vestibular schwannomas, OR\r\n** First-degree relative with NF2 and EITHER unilateral eighth nerve mass OR two of the following: neurofibroma, meningioma, glioma, schwannoma, juvenile posterior subcapsular lenticular opacity.\r\n* The Manchester criteria includes presence of:\r\n** Bilateral vestibular schwannomas, OR\r\n** First-degree relative with NF2 and EITHER unilateral eighth nerve mass OR two of the following: neurofibroma, meningioma, glioma, schwannoma, juvenile posterior subcapsular lenticular opacity, OR\r\n** Unilateral vestibular schwannoma AND any two of: neurofibroma, meningioma, glioma, schwannoma, juvenile posterior subcapsular lenticular opacity, OR\r\n** Multiple meningiomas (two or more) AND unilateral vestibular schwannoma OR any two of: schwannoma, glioma, neurofibroma, cataract
Normal functioning of daily living activities
Patients who are on the following drugs and cannot have a drug substitution: flecainide, methadone, amphetamines, quinidine, and chlorpropamide; high dose ascorbic acid may affect urine acidification and, as a result, may affect clearance rates of these drugs
Participants must be determined by an expert sarcoma surgeon to have resectable disease located on the upper extremity (including shoulder), lower extremity (including hip), trunk, retroperitoneum, or pelvis
A known hypercoagulable disorder such as activated protein C (APC) resistance (factor V Leiden), protein S deficiency, protein C deficiency, antithrombin III deficiency, hyperhomocystinemia, dysplasminogenemia, high plasminogen activator inhibitor, dysfibrinogenemia, antiphospholipid syndrome, thrombocythemia, or dysproteinemia
Bcr-Abl level by PCR must be less than or equal to 0.1% and greater than 0.0032% by PCR reported on the International scale. This will be confirmed during screening
Psychiatric problems of sufficient severity to limit full compliance with the study or expose patients to undue risk
Patients who are new visits to Female Sexual Medicine Program or patients who are not consistently using any vulvovaginal health promotion strategies (e.g., pelvic floor exercises, dilator therapy, moisturizers) recommended by the Female Sexual Medicine Program
post-polycythemia vera/essential thrombocythemia myelofibrosis (Post-ET/PV MF) per the International Working Group for Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) criteria
More than three relapses
Patients who are taking metronidazole and cannot be safely moved to a different antibiotic greater than 7 days prior to starting mebendazole therapy; metronidazole and mebendazole have been reported to be associated with Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis
Patients who have taken any benzimidazole (ABZ, flubendazole, thiabendazole, fenbendazole, triclabendazole, etc.) within the last 3 months
Patient is taking concurrent drugs that are contraindicated with nelfinavir, including any of the following:\r\n* Alfuzosin\r\n* Cisapride\r\n* Sildenafil (Revatio)\r\n* Amiodarone\r\n* Quinidine\r\n* Rifampin\r\n* Dihydroergotamine\r\n* Ergonovine\r\n* Ergotamine\r\n* Methylergonovine\r\n* Hypericum perforatum (St. John's wort)\r\n* Lovastatin\r\n* Simvastatin\r\n* Pimozide\r\n* Midazolam\r\n* Triazolam\r\n* Oral Midazolam
N-Terminal ProB-type natriuretic peptide (NTproBNP) < 8500 pg/mL
Presence of significant third space fluid which cannot be controlled by drainage
Creatinine equal or less than 1.4 mg/dl based on University of Iowa Hospitals and Clinics (UIHC) values/tests
Histologically confirmed classical HCL with one of the following:\r\n* Intolerance to purine analogs or considered to be poor candidates for purine analog-based therapy\r\n* Failure to achieve any response (CR or PR) to the initial purine analog-based therapy\r\n* Relapse =< 2 years of purine analog-based therapy\r\n* >= 2 Relapses\r\n* Histological confirmation of diagnosis will be performed at Memorial Sloan Kettering Cancer Center (MSKCC) or a participating site
Patients with known atypical transcript
Moderate or severe cGvHD diagnosed and staged per National Institutes of Health (NIH) criteria
Patients with synchronous primaries are included
Patients with recent excisional node biopsies/neck dissections are included if material is evaluable for extracapsular spread
Have a confirmed diagnosis of endometrial hyperplasia without atypia based upon endometrial biopsy
FL
Other indolent NHL (eg, MZL/MALT)
Graft:\r\n* Cryopreserved dose will be >= 1.5 x 10^7 total nucleated cells (TNC)/kilogram in each unit for double unit CB grafts; this will be the CB graft for the majority of patients\r\n* In select patients with access to CB units that have high TNC (> 5.0 x 10^7/kg), and are from good quality CB banks a single unit could be considered with a back-up CB unit on standby\r\n* In select patients who have a very poor search and only have one suitable CB unit available, this unit could be given as a single unit; this unit must have a TNC >= 2.0 x 10^7 TNC/kilogram and a cluster of differentiation (CD)34+ cell dose >= 1.5 x 10^5 CD34+/kilogram\r\n* Haplo-identical donors who are 5/10 or better but not HLA-identical will be used
Patients must be adequately recovered from surgery, radiation therapy, or any surgical complications prior to enrollment; in general, this means patients will be off antibiotics from wound infections and drains removed; however if necessary, patients can be treated with a drain in place at the discretion of the principal investigator (PI) if the 90 days window is about to expire
Uncontrolled infectious complications not responsive to appropriate antimicrobial therapy
Presence of gliomatosis cerebri, cranial or spinal leptomeningeal metastatic disease
Willing to abstain from therapeutic sunbathing, tanning beds, etc. for the duration of the study
An artificial (prosthetic) joint or other artificial implant or device that cannot be easily removed (with some exceptions for dental and breast implants and biliary stents and mediports)
Osteoporosis complicated by pathologic fracture
No extrapancreatic disease
Confirmation of resectability by surgical oncology consultation.
Presentation at a multidisciplinary conference at either University of Chicago or NorthShore University
Short removable metal stents rather than plastic stents are preferred but not required for palliation of initial obstructive jaundice
Indolent NHL:
Aggressive NHL:
For Part B:
Patients must be able to fit into either the Civco stereotactic immobilization or the Elekta Stereotactic BodyFix immobilization device
GROUP A MONOTHERAPY
ONLY APPLIES TO PATIENTS IN GROUP B
Participants must consent to collection of blood, ascites fluid and tumor tissue samples prior to first dose of CRLX101 and at least one additional sample collection after the second dose (archived material is acceptable for collection prior to first dose of CRLX101)
Patients who have used tobacco or nicotine products or medications within the last three months given their significant effect on erlotinib drug levels
Patients must not have psoriasis or porphyria
Completion of local RT with or without concomitant chemotherapy including temozolomide and radiosensitizing agents (e.g., carboplatin, vorinostat) outside the context of a clinical trial; any agent administered during RT should have a short half-life so that it should already be completely eliminated by the start of this therapy; if other agents were used concurrently with RT, they will need to be discussed with the principal investigator to assess eligibility
Presence of LGL clone prior to enrollment will not be an exclusion criterion if the LGL clone is < 25% of T cell population
Prohibited treatments and or therapies:\r\n* Category I drugs that are generally accepted to have a risk of causing Torsades de Pointes including: (patients must discontinue drug 7 days prior to starting dasatinib)\r\n** Quinidine, procainamide, disopyramide\r\n** Amiodarone, sotalol, ibutilide, dofetilide\r\n** Erythromycin, clarithromycin\r\n** Chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide\r\n** Cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine\r\n* Patient agrees to discontinue St. Johns wort while receiving dasatinib therapy (discontinue St. Johns wort at least 5 days before starting dasatinib)\r\n* Patient agrees that intravenous (IV) bisphosphonates will be withheld for the first 8 weeks of dasatinib therapy due to risk of hypocalcemia
Concurrent estrogens, anti-estrogens or progesterone compounds
If recent mold infection (e.g. Aspergillus) must have minimum of 30 days of therapy and responsive disease and be cleared by infectious disease
DONOR: Able and willing to undergo an apheresis procedure (unmobilized) for iTreg production and have up to 3 separate mobilized apheresis collections performed for PBSC transplant
Spinal hardware at either a) the vertebral body to be treated or b) one vertebra (VB) above and below
Prior kyphoplasty at either a) the vertebral body to be treated or b) one VB above and below
Extensive (> 50%) height loss of the involved vertebral body
Adequate swallowing function or gastric-tube for drug administration; of note, lapatinib can be administered via gastrostomy (G)-tube in a slurry for patients who cannot swallow
Grade 3 infection within 2 weeks of first dose romidepsin plus ICE.
Willing to comply with protocol therapy and required safety monitoring (self-report, pulse oximetry, remote spirometry, labs)
Information available for calculation of International Prognostic Score (IPS): age, gender; albumin, white blood cell (WBC) count, hemoglobin, lymphocyte count, and stage of disease according to Ann Arbor classification
Ki67 index ? 20% (to be centrally confirmed).
[Applicable only for France] All patients included in the trial must be affiliated with a social security regime or be a beneficiary of the same in order to be included in the study.
Any patient receiving treatment with short-acting Octreotide, which cannot be interrupted for 24 h before and 24 h after the administration of 177Lu-DOTA0-Tyr3-Octreotate, or any patient receiving treatment with Octreotide LAR, which cannot be interrupted for at least 6 weeks before the administration of 177Lu-DOTA0-Tyr3-Octreotate, unless the tumour uptake on target lesions observed by OctreoScan® imaging during continued Octreotide LAR treatment is at least as high as normal liver uptake observed by planar imaging.
For stage I seminoma patients only, definitive surgical intervention within ten weeks prior to registration; patients undergoing scrotal violations (scrotal orchiectomy, transscrotal biopsy, testicular fine needle aspiration, scrotal exploration) will be eligible
Pemetrexed arms only: presence of third space fluid which cannot be controlled by drainage
Additional exclusions for the 3 pazopanib containing arms (crizotinib plus pazopanib) and (pazopanib plus pemetrexed) and (crizotinib plus pazopanib plus pemetrexed):\r\n* History of stroke or transient ischemic attack within 6 months prior to study enrollment\r\n* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment\r\n* Urine for proteinuria >= 2+ (patients discovered to have >= 2+ proteinuria on urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate =< 1 g of protein in 24 hours to be eligible)
Therapy with supplements or complementary is excluded with the following exceptions; all other supplements must be discontinued prior to initiation of study drug\r\n* Conventional multivitamin supplements\r\n* Selenium\r\n* Lycopene\r\n* Soy supplements
Persistent neurotoxicity from intraventricular methotrexate, cytarabine, thiotepa
Saw palmetto administered with the intent to treat the patient’s malignancy within 1 week of degarelix injection for Cohorts 1, 2, and 4, and for within 1 week of surgery for Cohort 3
Two pretreatment CA125 values (documented on two occasions taken at least one week apart) must be at least twice the upper limit of normal, or twice the nadir value if pretreatment CA125 values never normalized
Granulocytes >= 1000/ul
Is currently participating in a GSK2110183 study (monotherapy or in combination with an approved anti-cancer agent) sponsored by GSK or by another research organization working on behalf of GSK.
Local access to commercially available GSK2110183.
Patients must have histologically confirmed pancreatic neuroendocrine tumors that are considered low or intermediate grade as defined by Klimstra et al (to include proliferation-related Ki-67 antigen [Ki-67] and mitotic index)
DISEASE-SPECIFIC EXCLUSIONS:
Individuals with a known t(9;22)/breakpoint cluster region-Abelson (BCR-ABL) fusion based on testing at either initial diagnosis or at relapse
Predisposing colonic or small bowel disorders in which the symptoms are uncontrolled, as indicated by a baseline pattern of > 3 watery or soft stools daily in patients without a colostomy or ileostomy; patients with a colostomy or ileostomy may be entered at investigator discretion
AST (GOT) ? 100 IU/L
ALT (GPT) ? 100 IU/L
Cardiogenic shock
Tumors in the body or tail of the pancreas (to the left of the portal-SMV confluence) are not eligible; location at the portal–SMV confluence is allowed
Patients cannot have hepatic or peritoneal metastases detected by imaging or laparoscopy prior to chemoradiation
Patients with an impending, life-threatening cerebral herniation syndrome, based on the assessment of the study neurosurgeons, Allan Friedman, John Sampson, or Peter Fecci, or their designate, will be excluded
Patients must not have diagnosis of agammaglobulinemia; patients with the following will be excluded:\r\n* Undetectable anti-tetanus toxoid IgG (except for retreatment)\r\n* Known history of agammaglobulinemia
Prior exposure to agents targeting interleukin 6 (IL 6) or the IL 6 receptor
Diagnosis of phenotypic classical FAP with disease involvement of the duodenum and/or colon/rectum/pouch.
Classical FAP Phenotype: 100's to 1,000's of colorectal adenomatous polyps, usually appearing in teenage years
Colon/rectum/pouch with high grade dysplasia or cancer on biopsy or a large polyp (>1 cm) not amenable to complete removal.
obscured by other structures or artifacts on the images)
Significant shunting to the lung (> 20%) identified on macroaggregated albumin (MAA) scan
Asymptomatic carriers of hepatitis B virus can be considered for study if they agree to and comply with close monitoring and suppressive therapy with lamivudine during treatment and for additional six months after coming off study.
Patients with neurofibromatosis 1
Autoimmune diseases or chronic decompensated diseases
Chronic systemic corticosteroids (unless required for treating treatment emergent AEs or required for management of signs or symptoms due to brain metastases, upon discussion with Bristol-Myers Squibb [BMS] medical monitor)
Sarcoma located on upper (includes shoulder) or lower (includes hip) extremities or on the body wall
Patients must not be pregnant or breast feeding. Patients must not be pregnant because lacosamide produced developmental toxicity in rats following administration during pregnancy. There is insufficient information to determine if lacosamide is safe during lactation.
Patients must not have any disease that will obscure toxicity or dangerously alter Drug metabolism
Perioperative anticonvulsants should be tapered as indicated in the protocol.
? 5 x PK half-life of a small molecule therapeutic not otherwise defined above
Patients who do not have hypo- or hyperthyroidism
Patients must fall into Radiation Therapy Oncology Group (RTOG) recursive partitioning analysis (RPA) class I or II
AIDS related syndromes or symptoms that pose a perceived excessive risk for transplantation-related morbidity as determined by the principal investigator.
Patients should not be taking drugs that are generally accepted to have a risk of causing Torsades de Pointes; the following must be discontinued at least 7 days prior to enrollment to be eligible: quinidine, procainamide, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, erythromycins, clarithromycin, chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide, cisapride, bepridil, droperidol, methadone, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine
For patients with MPN: Tolerating ruxolitinib but with persistent manifestations of disease (i.e. persistent splenomegaly, abnormal blood counts, persistent constitutional symptoms residual fibrosis in bone marrow [2+ or greater], or measurable allele burden as evidenced of clonal JAK2 or MPL mutation)
Suspected or documented radionecrosis
Any unresolved toxicity that meets the study treatment discontinuation or study withdrawal criteria from the parent study at the time of transition to this study.
Able to be treated with either a gamma knife or a linear accelerator-based radiosurgery system
Reasonable expectation that no chemotherapy will be given in the subsequent 6 months (principal investigator's [PI’s] discretion)
Inability or refusal to practice contraception during therapy (as physiologically relevant)
Subjects who received a tetanus- diphtheria (Td) or diphtheria toxoid/tetanus toxoid vaccine adsorbed (Tdap) immunization in the previous 5 years
Bronchiolitis obliterans as the sole indication of ECP
Patients with a prior history of marked intolerance to 5-fluoropyrimidines (5-FU, floxuridine, capecitabine, 5-fluorocytosine [flucytosine]), since such patients may have deficiency of dihydropyrimidine dehydrogenase, which places them at risk for severe and life-threatening toxicity with 5-FU
Patients requiring treatment with any other systemic glucocorticoid; NOTE: this restriction regarding choice of glucocorticoid does not apply should patient need < 2 week course of glucocorticoid for treatment of non-infectious pneumonitis during study
Evidence of frank hemorrhage or impending herniation on baseline brain imaging; NOTE: asymptomatic micro-hemorrhage is allowed
Patients of East Asian ancestry
History of treatment with eltrombopag, romiplostim or other thrombopoietin receptor (TPO-R) agonists
Treatment with drugs interacting with S-1, 5-FU, or cisplatin.
Patients with symptomatic cholelithiasis (asymptomatic gall stone discovered on screening ultrasound [US] should be reviewed by the principal investigator [PI] but will not lead to automatic exclusion)
Patients with the presence of active or suspected acute or chronic uncontrolled infection or with a history of immunocompromise, including a positive HIV test result (enzyme-linked immunosorbent assay [ELISA] and western blot)
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption
Patients with porphyria cutanea tarda
Have adequate cardiovascular function as defined by: i) a normal B-type natriuretic peptide (BNP) with ii) no signs or symptoms suggestive of cardiac disease and iii) a normal electrocardiogram (ECG); if these criteria are not met, patients must have an echocardiogram or multigated acquisition cardiac scan (MUGA) showing an ejection fraction (EF) of 45% or greater with no more than \mild\ diastolic dysfunction and a BNP of < 200 pg/mL to be eligible
Infectious process, which, in the opinion of the investigator, could worsen or its outcome be affected, as a result of the investigational therapy
Hydronephrosis (either bilateral or involving a solitary kidney) that has not been addressed by means of a nephrostomy or indwelling stent; EXCEPTION: non-obstructive hydronephrosis in setting of prior urinary diversion is consistent with eligibility
Concurrent therapy with a Selective Serotonin Reuptake Inhibitor (SSRI), tricyclic antidepressant, or Monoamine Oxidase Inhibitor (MAOi); clinical judgment should be used in a decision to discontinue antidepressants; a minimum of a 1 week washout period is required for any tricyclic or related antidepressant, or any SSRI (2 weeks for paroxetine or sertraline, 5 weeks for fluoxetine); minimum 2 week washout for any MAOi
Caution should be exercised in patients who are regularly taking narcotic analgesics, particularly higher doses; the doses of narcotic analgesics may need to be reduced, patients may need to be monitored closely for drug interactions, and the risks and benefits of participation in the study should be considered; clinical judgment should be exercised to manage this potential drug interaction
Patients must have had FISH evaluation of leukemia cells within 3 months without intervening treatment demonstrating deletion 11q22-23
Have predisposing conditions that are consistent with development of aneurysms of the ascending aorta or aortic stress
Successful completion of three 24-hour dietary recalls during the run-in period
Has demonstrated compliance with study drug(s), treatment visit schedules, and the requirements and restrictions listed in the consent form
Local access to commercially available GSK2118436
Surgery must be planned to be performed by a pre-approved, study-specific credentialed surgeon; the registering physician MUST be the pre-approved, credentialed surgeon intended to perform the assigned procedure
Existing cortical bone destruction, where orthopedic stabilization would be required
Patients with N-terminal (NT)-proB-type Natriuretic Peptide (BNP) >= 1800 ng/L or BNP >= 400 ng/L, abnormal troponin T, cardiac muscle (cTnT) or troponin I, cardiac muscle (cTnI) can only be included after evaluation by cardiology to determine of the risk associate with the treatment; this evaluation needs to be discussed with the principal investigator (PI)
Must be able to anticipate achieving SBRT/RT dosimetry guidelines
Untreated T1-4 and N1-2 disease will be treated with radiation therapy using 5 to 7 weeks of daily radiotherapy per standard practice; must be able to anticipate meeting lung dosimetry guidelines
Other prohibited medications: \r\n* Oral hypoglycemics: tolbutamide, chlorpropamide; \r\n* Ergot derivatives: dihydroergotamine, ergonovine, ergotamine, methylergonovine; \r\n* Neuroleptics: pimozide; \r\n* Antiarrhythmics: amiodarone, bepridil, flecainide, lidocaine, mexiletine, quinidine, propafenone; \r\n* Immune modulators: cyclosporine, tacrolimus, sirolimus; \r\n* Miscellaneous: theophylline, quetiapine, risperidone, tacrine, clozapine, atomoxetine
EXPANSION COHORT ONLY: Other prohibited medications: \r\n* Oral hypoglycemics: tolbutamide, chlorpropamide; \r\n* Ergot derivatives: dihydroergotamine, ergonovine, ergotamine, methylergonovine; \r\n* Neuroleptics: pimozide; \r\n* Antiarrhythmics: amiodarone, bepridil, flecainide, lidocaine, mexiletine, quinidine, propafenone; \r\n* Immune modulators: cyclosporine, tacrolimus, sirolimus; \r\n* Miscellaneous: theophylline, quetiapine, risperidone, tacrine, clozapine, atomoxetine
Advanced/poorly differentiated thyroid cancers of follicular cell origin that have no uptake (< 1%) on radioiodine scan or are unresponsive to radioiodine therapy; unresponsiveness to radioiodine therapy is defined as a patient’s thyroglobulin not falling to less than 2 ng/ml within 6 months after previous radioiodine ablative treatment
Thyroglobulin (Tg) levels greater than or equal to 100 ng/ml in the absence of Tg antibodies; patients who are Tg-antibody (Tg-Ab) positive may be included despite a lower Tg level if they have detectable disease on cross sectional imaging; (the presence of Tg-Ab may lead to falsely low Tg levels and therefore render the Tg a less sensitive marker of disease; however, Tg-Ab has been shown to also act as a tumor marker, and will be used as an endpoint for the study in patients who are Tg-Ab positive)
There are other criteria--please discuss with your doctor.
There are other criteria--please discuss with your doctor.
Negative post-lumpectomy mammography if malignancy-associated microcalcifications were initially present
Patients with Paget’s disease of the nipple
PB or BM basophils ?20%
Patients must not have any disease that will obscure toxicity or dangerously alter drug metabolism
Patients must not take the following medications that are strong to moderate inhibitors of CYP2D6 and may alter tamoxifen metabolism: paroxetine (Paxil), fluoxetine (Prozac), buproprion (Wellbutrin) and quindine (Cardioquin) within 2 weeks of registration
Current evidence of corneal or retinal disorder, including but not limited to bullous/band keratopathy, keratoconjunctivitis, corneal abrasion, inflammation/ulceration, confirmed by ophthalmologic examination
Hydroxyurea for cytoreduction
Presence of leg ulcers or other unacceptable mucocutaneous manifestations at any dose of hydroxyurea.
Any unresolved toxicity (CTCAE grade > 1) from previous anti-cancer systemic therapy unless approved by one of the principal investigators (Drs. Lee or Sherman); rare exceptions that would not affect the study (e.g., radiation induced dysphagia) allowed with the consent of either principal investigators (Drs. Lee or Sherman)
Histologically confirmed diagnosis of grade 2 or 3 out of 3 UPS or dedifferentiated/pleomorphic LPS of the extremity (including limb girdle, i.e. shoulder or hip) that measures greater than 5 cm in any direction as assessed by imaging; Alternative terms for UPS meeting inclusion criteria include but are not limited to the following
Confirmation of MET-driven PRCC without co-occurring Fumarate Hydratase or Von Hippel Lindau mutations from a tumour sample using the sponsor-designated central laboratory validated MET Next Generational Sequencing assay
Prior transarterial chemoembolization (TACE)
T2, N0-N2
T3, N0-N2
T4a-d, N0-N2
Documented lymphoid or myeloid neoplasm with 8p11 rearrangement known to lead to FGFR1 activation, based on standard diagnostic cytogenetic evaluation performed locally, before signing informed consent for this study.
Current evidence of corneal disorder/keratopathy, including but not limited to bullous/band keratopathy, corneal abrasion, inflammation/ulceration, and keratoconjunctivitis, as confirmed by ophthalmologic examination.
Prior exposure to radio- or toxin-immunoconjugates
Meets one or more Groupe d'Etude des Lymphomes Folliculaire (GELF) criteria.
Histologic diagnosis of squamous cell carcinoma of the oral cavity including the lip, floor of mouth, anterior 2/3 of tongue, alveolus and gingiva, buccal mucosa, hard palate and retromolar trigone
combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)
progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)
Adequately functioning bladder, defined as continent and without the need for an indwelling catheter
Patients with a tracheoesophageal (TE) fistula or direct invasion into the mucosa of the trachea or major bronchi; bronchoscopy is encouraged if a TE fistula is suspected; the presence of a fistula will exclude a patient from this study
Platelets >= 50 x 10^9/L, unless cytopenias are deemed due to disease
Absence of macroscopic disease after upfront surgery (i.e., TxNx and TxN0; TxN+ and T1-3Nx are eligible if the T/N stage categories meet the criteria above)
Granulocytes >= 1,500/ul
Known intolerance of vorinostat
Patients with pathologically confirmed unresectable or borderline resectable squamous cell carcinoma of the larynx, hypopharynx, nasopharynx and oropharynx will be eligible for enrollment to the clinical trial; patients will be deemed unresectable if they have clinically confirmed carotid artery encasement, skull base involvement, trismus or deep neck musculature invasion at the time of diagnosis; borderline resectability will be defined as those patients in which surgery is unlikely to result in excision of all macroscopic disease or will result in a total base of tongue glossectomy, total laryngopharyngectomy, skull base resection or carotid resection
Clinically (medically) indicated procedure (i.e. biopsy of lesions of recurrent disease, palliative management via resection, thoracentesis, etc.) to collect tumor in sufficient quantity (\golf ball size\ estimated weight 10-30 grams, pleural, and/or ascites fluid estimated volume ? 500 mL) for vaccine processing.
Patients with microscopic and/or gross extra thyroidal disease extension without RAI uptake but with a) FDG-PET positive disease or b) suppressed thyroglobulin >1 ng/mL or c) stimulated thyroglobulin >10 ng/L.
Patients with tracheal/esophageal involvement. High mitotic activity or necrosis in pathology does not exclude from the study. Note: in Categories a and b, patients can be followed using US locally in addition to standard diagnostic followup menu but, if US only is positive, a FDG-PET or MRI will be obtained. If negative, a rising thyroglobulin titer is required in which case response will be monitored by continued US and suppressed and/or stimulated thyroglobulin. Thyroglobulin titer cannot be used if anti-thyroglobulin antibodies are present).
Inability to collect adequate stem cells
The patient must currently have at least one of the following:\r\n* Uncontrolled symptoms, defined as any of the following:\r\n** Headaches associated with mass effect\r\n** Uncontrolled seizures despite 2 different antiepileptic drug regimens (i.e., 2 antiepileptic drugs tested either sequentially or in combination)\r\n** Focal neurological symptoms\r\n** Cognitive symptoms or deficits OR\r\n* Tumor progression by serial magnetic resonance imaging (MRIs), defined as any of the following:\r\n** New or progressive enhancement\r\n** New or progressive T2 or fluid attenuated inversion recovery (FLAIR) signal abnormality OR\r\n* Age >= 40 years\r\n** NOTE: Patients aged less than 40 whose only symptom of low-grade glioma is seizures that are well-controlled on antiepileptic drugs, and who have no evidence of radiographic progression, are ineligible
HLA-A*0201 positive (to enable immunization with the HLA class I restricted gp100[g209-2M] peptide); stage IIB or IIC patients will be enrolled after review and approval by the principal investigator (PI); (a tool to determine the projected survival at 5 years, like, but not limited to, the nomogram at www.melanomaprognosis.org; if the projected survival is less than 50% at 5 years, then the patient is considered for enrollment; this is with the recognition that the adjuvant, if effective offers a significant impact in that group of stage II patients)
Patients may not be receiving any medication that may markedly affect renal function (e.g., vancomycin, amphotericin, ibuprofen, pentamidine)
Evaluable KS involving the skin and/or viscera, including at least one of the following:\r\n* KS of the skin with >= 5 KS lesions that are evaluable by non-invasive methods that have not been treated with local therapeutic modalities\r\n* Pulmonary KS evaluable by computed tomography (CT) scan\r\n* Gastrointestinal KS evaluable by direct visualization or fiberoptic instrumentation\r\n* Biopsy proven lymph node involvement measurable by CT scan
Surgical or other non-healing wounds, other than KS ulcers
Patients with any other abnormality that would be scored as a grade 3 or greater toxicity, except:\r\n* Lymphopenia\r\n* Direct manifestations of KS\r\n* Direct manifestation of HIV\r\n* Direct manifestation of HIV therapy (i.e. hyperbilirubinemia associated with protease inhibitors)\r\n* Asymptomatic hyperuricemia\r\n* Hypophosphatemia
Uncontrolled hyperthyroidism or hypothyroidism
Patients with known splenomegaly
Category I drugs that are generally accepted to have a risk of causing Torsades de Pointes or prolonged QT interval including: (Patients must discontinue drug 7 days prior to starting dasatinib)\r\n* Quinidine, procainamide, disopyramide\r\n* Amiodarone, sotalol, ibutilide, dofetilide\r\n* Erythromycin, clarithromycin\r\n* Chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide\r\n* Cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine
Patients must satisfy the American College of Rheumatology (ACR) criteria for the diagnosis of SLE
Patients must have at least one of the following for inclusion into protocol:\r\n* Lupus nephritis, defined as renal biopsy (biopsy within 6 months of transplant decision) showing glomerulonephritis, with active diffuse proliferative lesion (World Health Organization [WHO] stage IV or Vd, with biopsy classified by WHO criteria)\r\n* Refractory and severe seizures or encephalopathy attributed to SLE\r\n* Severe pulmonary involvement with recurrent pulmonary hemorrhage; and/or refractory pulmonary infiltrate not attributed to infection; and/or interstitial lung disease- defined by presence of alveolitis or pneumonitis on high-resolution computed tomography (CT) scan or documentation of DLCO < 80% at least twice\r\n* Transfusion-dependent cytopenias that are unresponsive to standard treatment\r\n* Catastrophic antiphospholipid syndrome, which is defined as an antiphospholipid titer greater than 5 standard deviations above the mean and two or more antiphospholipid related manifestations, including either cytopenias or vascular thrombosis that failed to respond to anticoagulant therapy\r\n* Vasculitis and/or immune complex deposition causing end-organ signs or symptoms, e.g. cerebritis, cardiac failure, or renal failure, refractory to standard treatment
Patients must have received a trial of IV cyclophosphamide pulse greater than 500 mg/square meter at least once within the previous 6 months, unless contraindicated because of severe cytopenias or intolerance
A Kurtzke extended disability status scale (EDSS) of 2.0 to 6.0
Active infectious disease concerns
Diagnosis of grade 2 endometrioid endometrial carcinoma or higher on endometrial biopsy or on dilation and curettage specimen
Congenital or acquired uterine anomaly which distorts the uterine cavity
Genital actinomycosis
Confirmed diagnosis of aggressive systemic mastocytosis (ASM) or mast cell leukemia (MCL) according to WHO criteria for SM and established criteria for ASM and MCL (Valent et al 2003), presenting with at least one measurable C-Finding.
Central nervous system involvement as documented by spinal fluid cytology or imaging. Subjects who have signs or symptoms suggestive of leukemic meningitis or a history of leukemic meningitis must have a lumbar puncture procedure performed within two weeks prior to randomization.
Evidence of TLS per the Cairo-Bishop definition of laboratory TLS (subjects may be enrolled upon correction of electrolyte abnormalities).
Uncontrolled hyperthyroidism or hypothyroidism
intra-prostatic calcifications >1.0 cm (single or continuous grouping) on 2 or more consecutive images along the same plane by either the TRUS or Sonablate 500 measurement will not be enrolled;
body weight which would preclude proper suprapubic catheter functioning, per investigator's discretion
history of urethral stent or urethral surgery (urethral dilation, urethroplasty); a Uroflow exam may be conducted at the investigators discretion;
fully active at a minimum or fully capable of selfcare and up and about more than 50% of waking hours
Confirmed pathologic diagnosis of a solid tumor that is not curable with available therapies for which HKI-272 plus vinorelbine is a reasonable treatment option (part 1 only) or Confirmed pathologic diagnosis of ErbB-2-positive breast cancer (current stage IV) in female subjects for which vinorelbine plus HKI-272 is a reasonable treatment option (part 2 only).
Other serious co-morbid illness or compromised organ function
The patient must have a histopathologic diagnosis of a World Health Organization (WHO) grade IV GBM as confirmed by the study pathologist, Roger McLendon, or his designate; the patient must undergo leukapheresis after definitive resection; residual radiographic contrast enhancement on post-resection computed tomography (CT) or magnetic resonance imaging (MRI) must not exceed 1 cm in diameter in two perpendicular axial planes; patients with evidence of contrast-enhancement exceeding 1 cm in diameter in two perpendicular axial planes after radiation will not be a candidate for the vaccine despite being previously enrolled and will be removed from the study and replaced; those that have transformed to a grade IV GBM from a lower grade glioma will be eligible so long as they are treatment naïve other than steroids, radiation therapy (RT), or TMZ
The patient's hematopoietic cell transplant donor must consent to a 2 volume leukapheresis or whole blood donations obtained at one phlebotomy which will total approximately 250 ml from which the WT-1 specific T cells to be used for adoptive transfer will be generated
Patients unable to withstand prolonged lithotomy and steep Trendelenburg position
Medulloblastoma patients >= 3 and < 5 years old at diagnosis who have non-metastatic disease with no more than 1 cm^2 of residual tumor are also eligible; medulloblastoma patients in the >= 3 and < 5 years old age group with anaplastic or large cell histology or with v-myc avian myelocytomatosis viral oncogene homolog (MYC) or v-myc avian myelocytomatosis viral oncogene neuroblastoma derived homolog (MYCN) amplification are excluded; pathology from collaborating institutions must be centrally reviewed prior to enrollment for confirmation
Histologic diagnosis of nodular desmoplastic medulloblastoma (includes medulloblastoma with extensive nodularity); patients with focal areas of anaplasia or other atypical features suggesting a more aggressive phenotype in a tumor which would otherwise be considered nodular desmoplastic should be treated on the intermediate risk arm; in such unusual cases, final risk stratification will be at the discretion of the principal investigator and study pathologist
Prior radiation to maximally tolerated levels to any critical normal organ
(10. continued) (such as presurgically for obtaining pharmacology data for the agent) will be eligible to enter the study provided they have recovered from the toxic effects of the agent if any. Any questions related to the definition of non-cytotoxic agents should be directed to the Study Chair.
Prior treatment with isotretinoin is allowed because the trial is based on the hypothesis that HDAC inhibition will potentially overcome resistance to retinoids.
Group A: Pathologic fracture or impending pathologic fracture of the femur;
Group A: Intramedullary rod, plating, cementation, hip arthroplasty, or knee arthroplasty.
Surgical drain output > 500 cc of bloody fluid during first 8 hours
I.N.R. > 1.3 pre-operatively or > 1.5 post-operatively
Platelet count < 100,000 either pre-operatively or post-operatively
Patients who have fragmented mechanical heart valves
Myeloproliferative disorders (idiopathic myelofibrosis, polycythemia vera, essential thrombocytosis, chronic myelomonocytic leukemia, agnogenic myeloid metaplasia)\r\n* Agnogenic myeloid metaplasia with adverse-risk features \r\n* Polycythemia vera or essential thrombocythemia in transformation to secondary AML
Patients with cutaneous T-cell lymphomas (e.g. mycosis fungoides, Sezary syndrome) must have:\r\n* Stage III or greater disease\r\n* Disease which has progressed on or failed to respond to at least 2 therapies including one systemic therapy
Patients must have a family member who is matched at 2, 3, or 4 HLA antigens typed as described above and willing to donate 80-100 ml or bone marrow for mesenchymal stem cell (MSC) generation or the angioblast mesenchymal precursor cells will be used for the cord blood co-cultures; patients that are high risk for relapse are eligible to use the angioblast \off-the-shelf\ mesenchymal precursor cells
Willingness to provide all biological specimens as required by the protocol
Exposure to household contacts =< 15 months old or household contact with known immunodeficiency
Patients who have a programmable shunt will not be excluded
Patients with obstructive or symptomatic communicating hydrocephalus
Patients must have no rapidly progressing or deteriorating neurologic examination
Patients who fulfil the diagnostic criteria of HLH.
Specific eligibility criteria stratum 3:\r\n* Disease status: \r\n** Patients must have a radiographically progressive plexiform neurofibroma(s) with or without clinical symptoms; progression at the time of study entry is defined as: \r\n*** Presence of new plexiform neurofibromas on MRI within the last 12 months OR\r\n*** A measurable increase of the plexiform neurofibroma (>= 20% increase in the volume, or a >= 13% increase in the product of the two longest perpendicular diameters, or a >= 6% increase in the longest diameter) over the last two consecutive scans (MRI or computed tomography [CT]), or over the time period of approximately one year prior to evaluation for this study
Prior administration of interferon alfa-2b or PEG-Intron
Patients with symptomatic uremia, uncontrolled edema or unstable serum electrolytes should not enter the trial until such time as they have been stabilized – such patients should be discussed with the principal investigator
Eligibility of patients receiving any medications or substances known to affect or with the potential to affect the activity or pharmacokinetics of E7389 Halichondrin analog will be determined following review of their case by the principal investigator
Over-expression of HER2
All stages of disease
Patients must have an alanine transaminase (ALT) < 5 x ULN for age; these criteria may be waived for patients with known or suspected liver involvement by leukemia following review and approval by the study chair or vice chair
Patients will be excluded if there is a need to administer drugs that inhibit platelet function, such as aspirin or clopidogrel; for such medications a wash-out period of >= 7 days is required prior to starting dasatinib
History of severe allergy to any of the components of NEOD001 such as histidine/L-Histidine, Trehalose, or Polysorbate 20
Active diverticulitis.
Undergoing ileoanal reconstruction, total colectomy or proctocolectomy, abdominoperineal resection, Hartmann's procedure, Hartmann's reversal or multiple synchronous colon resections (e.g., LAR and concomitant right colectomy).
Subjects must have received initial cisplatin based combination therapy, such as bleomycin-etoposide-cisplatin (BEP), cisplatin-etoposide (EP), etoposide-ifosfamide-cisplatin (VIP), or similar regimens AND demonstrated progression following the administration of at least one ‘salvage’ regimen for advanced germ cell neoplasm, such as high dose chemotherapy, paclitaxel-ifosfamide-cisplatin (TIP), or vinblastine-ifosfamide-cisplatin (VeIP)
Major immunologic reaction to any IgG containing agent or auristatin based agent
Confirmation of AR+ (defined as ? 10% nuclear AR staining by immunohistochemistry [IHC]) TNBC in either the primary or metastatic lesion, assessed during the screening period by a local laboratory or by medical history
Estrogens
Patients must be at least 1 week from the last dose of complementary or alternative medications
Group 1: Patients must have 1) both a and b below; and 2) at least one of c, d or e:\r\n* a. diffuse cutaneous scleroderma with skin score of greater than or equal to 16 (modified Rodnan scale [mRSS])\r\n* b. duration of systemic sclerosis less than or equal to 7 years from the onset of first non-Raynaud’s symptom\r\n* c. presence of interstitial lung disease (either forced vital capacity [FVC] or corrected diffusing capacity of the lung for carbon monoxide [DLCOcorr] less than 70 % of predicted) and evidence of alveolitis (abnormal bronchoalveolar lavage (BAL) or high resolution chest computed tomography [CT] scan) after treatment with intravenous cyclophosphamide greater than or equal 2 grams given over at least a 3 month period; for patients not able to adequately complete pulmonary function tests (PFT), there must be evidence of progressive disease on chest CT\r\n* d. left heart failure with left ventricular ejection fraction (LVEF) < 50% (that has responded to treatment targeted to scleroderma); 2nd or 3rd atrioventricular (AV) block with other evidence of cardiomyopathy related to SSc; myocardial disease not secondary to SSc must be excluded by a cardiologist \r\n* e. history of SSc-related renal disease that is not active at the time of screening; history of scleroderma hypertensive renal crisis is included in this criterion
Group 2: Progressive pulmonary disease as defined by a decrease in the FVC or DLCOcorr by 15 percent or greater compared to a prior FVC or DLCOcorr in the previous twelve month period; in addition, patients may have either less skin involvement than group 1 (mRSS less than 16) and the FVC or DLCOcorr is less than 70% or both FVC and DLCOcorr greater than or equal to 70% if they have diffuse cutaneous disease (mRSS greater than 16) at screening for the study; patients must also have evidence of alveolitis as defined by abnormal chest CT or BAL; for patients not able to adequately complete PFT, there must be evidence of progressive disease on chest CT
Group 5: Diffuse scleroderma with disease duration less than or equal to 2 years since development of first sign of skin thickening plus modified Rodnan skin score greater than or equal to 25 plus erythrocyte sedimentation rate (ESR) > 25 mm/1st hour and/or hemoglobin (Hb) < 11 g/dL, not explained by causes other than active scleroderma
Unless patients have a DLCO-adjusted less than 45%, patients in all groups must have failed either oral or intravenous cyclophosphamide regimen defined as: IV cyclophosphamide administration for at least > 3 months between first and last cyclophosphamide dose at a total cumulative IV dose of at least 2 grams, oral cyclophosphamide administration for > 4 months regardless of dose, or combination of oral and IV cyclophosphamide for at least > 6 months independent of dose
Prior exposure to a pyrrolobenzodiazepine or indolinobenzodiazepine based drug.
Mature B cell (Burkitt’s) ALL
Asymptomatic or mildly symptomatic
Presence of extra-hepatic spread of disease.
Patients with the following TNM stages are eligible: \r\n* pT3aN0-2 (pN0;pN1;pN2) provided less than 10 nodes dissected and/or positive surgical margins\r\n* pT3bN0-2 (pN0;pN1;pN2)\r\n* pT4aN0-2 (pN0;pN1;pN2)\r\n* pT4bN0-2 (pN0;pN1;pN2)
Diagnosis of primary MF (PMF) or secondary MF (PET-MF and PPV-MF) as per WHO 2008 criteria.
Active symptomatic MF as defined by the screening MPN-SAD patient-reported instrument requiring a severity score of at least 5 on one symptom, or a severity score of ? 3 on at least two of the symptoms (on a 0 to 10 scale).
One to two painful vertebrae (T1-L5) with evidence of osteolytic or mixed lytic and blastic metastatic lesion by cross sectional imaging and pathologic fracture (presence of non-painful vertebrae with metastatic lesions in addition to the painful index vertebrae are allowed)
Compromise in the posterior column of the vertebral body or walls of pedicles.
Additional non-kyphoplasty/vertebroplasty surgical treatment is required for the index vertebra(e),
Bedridden due to paralysis or neurological decline,
Modified Glasgow Prognostic Score (mGPS) of 1 or 2 as defined below:
Cumulative Illness Rating Scale score > 6, by assessment of the investigator
All sites of metastasis must be measured in 3 planes, in millimeters and stored in Pediatric Oncology Network Database (POND) (a web-based data network, secure, independent and password protected)
Patients must have had 2 or more prior therapeutic attempts defined as:
Patients with a history of prior veno-occlusive disease (VOD) or findings consistent with a diagnosis of VOD, defined as: conjugated serum bilirubin >1.4 mg/dL AND unexplained weight gain greater than 10% of baseline weight or ascites AND hepatomegaly or right upper quadrant pain without another explanation, OR reversal of portal vein flow on ultrasound, OR pathological confirmation of VOD on liver biopsy.
Patients must have histologic or cytologic confirmation of cancer for which there is no known standard therapy capable of extending life expectancy
Adequate tissue must have been obtained from surgical intervention to satisfy biospecimen requirements of study (collected under biospecimen collection protocols; either AAAO5706 principal investigator [PI]: Yvonne Saenger or AAAR1327 PI: Adrian Sacher)
Be of nonchildbearing potential:
Subject must be willing to fast for approximately 10 hours predose and 4 hours postdose on day 1 of each period in the pharmacokinetic phase.
Consistent and correct usage of established hormonal contraceptives that inhibit ovulation,
Patients with monocular vision or have media opacities or any other condition that precludes monitoring of the retina or fundus.
Schistocytes on peripheral blood smear (>2 per HPF) OR histologic evidence of microangiopathy
Positive HIV (ELISA and Western blot) test result (checked at screening). Historical local data will be acceptable if it the test was done within one month before start of HSCT conditioning and not more than 3 months before study visit 3.
Patients with known or suspected hereditary complement pathway deficiency. This exclusion criterion is not applicable to patients with complement pathway abnormalities/upregulation known to be associated with increased risk of transplant associated microangiopathy
Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations
Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, flucinolone 0.01%, desonide 0.05%, aclometasone dipropionate 0.05%)
Prior treatment with antiPD-1, or antiPD-L1 therapeutic antibody or pathway targeting agents
Mercury (Hg) > 8 gr/dL
Patients who are expected to require any of the following therapies between enrollment and completion or discontinuation of the study treatment:\r\n* Immunosuppressive drugs, including corticosteroids, methotrexate, mercaptopurine, azathioprine, cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, ATG (anti-thymoglobulin), interleukin 2 (IL2)-receptor antibodies (basiliximab, daclizumab), tumor necrosis factor (TNF)-a antibodies (infiliximab, etanercept, adalimumab)\r\n* Radiotherapy for the target disease\r\n* Surgical therapy for the target disease
Patients with obstructed gastrointestinal tract or uncontrolled vomiting
Uncontrolled symptomatic orthostatic hypotension
The need for treatment with medications with clinically relevant metabolism by the cytochrome P450 (CYP) 3A4 isoenzyme within 3 hours before or after administration of SNX-5422 (Appendix B).
Evidence of diffuse, spontaneous terminal hair regrowth
Be of nonchildbearing potential:
LVEF >= 45% at rest (by ECHO)
Minor changes from the required initial laboratory data guidelines will be allowed at the discretion of the attending team under special circumstances; the reasons for exceptions must be documented prior to enrollment
For patients with oropharyngeal cancer, p16 status is known or can be determined
Skull defect (e.g. missing bone with no replacement)
Shunt
Bullet fragments
Patients receiving any disease-modifying anti-rheumatic drug (DMARD)
Neurologic disease including multiple sclerosis, Eaton-Lambert syndrome, demyelination
Patients must be considered ineligible for rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate and prednisone (R-CHOP) standard therapy; to be ineligible for R-CHOP, patients must meet at least one of the following criteria are met:\r\n* Prior anthracycline therapy for other malignancies or other disorders whereby if additional anthracyclines are given for DLBCL, the maximum lifetime allowable dose will be exceeded\r\n* Meeting the geriatric criteria of ineligibility for standard R-CHOP if one of the following criteria is present:\r\n** Three or more organ systems with a score of 3 or any 1 organ system with a score of 4 (using the Cumulative Illness Rating Scale for Geriatrics, [CIRS-G])\r\n** Score of 3 or above on the Vulnerable Elders Survey (VES-13)\r\n** Score of =< 9 in the short physical performance battery (SPPB)\r\n** Presence of a significant geriatric syndrome (dementia, delirium, falls, incontinence, malnutrition, and severe osteoporosis) in the past year prior to diagnosis\r\n** Any abnormality in performing activities of daily living (ADLs) or instrumental activities of daily living (IADLs)
Active diverticulitis
Patients with idiopathic myelofibrosis or myelofibrosis secondary to polycythemia vera or essential thrombocythemia
Gastroduodenal artery encasement up to the hepatic artery with either short segment encasement or direct abutment of the hepatic artery without extension to the celiac axis.
Tumor abutment of the SMA not to exceed greater than 180 degrees of the circumference of the vessel wall.
Tail: SMA or celiac encasement greater than 180 degrees.
Active diverticulitis.
Prior radioimmunotherapy
Persistent cytopenia requiring growth factors and/or blood products AND evidence of hypocellular BM (< 25%); persistent cytopenia (at least 4 week period) is defined by presence of TWO of the following:\r\n* Absolute neutrophil count (ANC) < 1.0 x 10^9/L without filgrastim support or any ANC value that requires recurrent support by filgrastim (administered at least once a week)\r\n* Platelets (Plt) < 50 x 10^9/L\r\n* Hemoglobin (Hb) < 8 or packed red blood cell (PRBC) transfusion dependent (once every 2 weeks or more) with reticulocyte count of < 40 x 10^9\r\n* This criteria for persistent cytopenia and hypocellular bone marrow does not apply to patients with auto-immune cytopenia ONLY PGF patients
Full donor myeloid chimerism; patients after T cell depletion transplant can have a significant mixed T cell chimerism and this can affect the testing of marrow chimerism; in this case, the neutrophil chimerism will be used to determine eligibility for this trial; patients will be excluded if neutrophils are less than 90% donor cells; a higher percentage of host cells could be due to relapse or impending relapse
Evidence of relapsed disease by morphologic, cytogenetic or molecular diagnostic tools
In the opinion of the HCT center will be ready to begin pre-transplant conditioning within 6 weeks of trial enrollment from a medical and psychosocial standpoint
Patients with extrapleural pneumonectomy (EPP)
Discontinued a BTKi therapy due to BTKi treatment-related intolerance
Refractory to obinutuzumab (defined as progression or relapse <12 months of receiving obinutuzumab monotherapy or <24 months of receiving an obinutuzumab-containing regimen)
Patient should preferably have received a pre-transplant conditioning with rituximab and carmustine/etoposide/cytarabine/melphalan/Rituxan (BEAM/R); other regimens which are similar may be accepted at the discretion of the principal investigator (PI)
For those patients who had a biliary stent inserted, 2 stable bilirubin readings within 48 to 72 hours of each other taken at least 5 days and not more than 14 days post-stenting must be obtained. In addition, there should be no complications (eg, infection) present and bilirubin levels should have stabilized (2 readings with total bilirubin within 20% of each other) before administering first treatment.
History of diverticulitis (even a single episode) or evidence of diverticulitis at baseline, including evidence limited to computed tomography (CT) scan only; note: diverticulosis is not an exclusion criterion per se
Active thyroiditis
Patients may enroll in this study if they are thought to have no residual disease after TURBT
Urethral strictures that would prevent endoscopic procedures and repeated catheterization
Patients with implantable or wearable electrical devices will be excluded from this study
Patients with mycosis fungoides or Sezary syndrome must have stage IIb-IV disease (by International Society of Cutaneous Lymphoma [ISCL]/European Organization for Research and Treatment of Cancer [EORTC] criteria)
History of treatment with eltrombopag, romiplostim or other thrombopoietin receptor (TPO-R) agonists
Has an active infectious process
Inability or unwillingness to take supportive medications including a centrally acting appetite stimulant (e.g., mirtazapine or olanzapine) and a peripherally acting appetite stimulant (e.g., low dose glucocorticoids or megesterol acetate).
Serologic documentation of HIV infection by any of the Food and Drug Administration (FDA)-approved tests; alternatively, this documentation may include a record that another physician has documented that the participant has HIV infection based on prior enzyme-linked immunosorbent assay (ELISA) and Western blot, or other approved diagnostic tests
Serologic documentation of HIV infection at any time prior to study entry, as evidenced by positive enzyme-linked immunosorbent assay (ELISA), positive Western blot, or any other federally approved licensed HIV test; alternatively, this documentation may include a record that another physician has documented that the participant has HIV infection based on prior ELISA and Western blot, or other approved diagnostic tests
Participants should not have significant abnormalities of the cornea based on history (e.g., dry eye syndrome, Sjogren’s syndrome), congenital abnormality (e.g., Fuch’s dystrophy), abnormal slit-lamp examination using a vital dye (e.g., fluorescein, Bengal-Rose), and/or an abnormal corneal sensitivity test (Schirmer test or similar tear production test)
For any surgery or invasive procedure requiring sutures or staples for closure, ibrutinib should be held at least 7 days prior to the intervention and should be held at least 7 days after the procedure, and restarted at the discretion of the investigator when the surgical site is reasonably healed without serosanguineous drainage or the need for drainage tubes
An mGPS of 1 or 2 as defined below:
modified Glasgow prognostic score (mGPS) of 1: CRP > 10 mg/L and albumin ? 35 g/L
An modified Glasgow Prognostic Score (mGPS) of 1 or 2 as defined below:
mGPS of 2: CRP > 10 mg/L and albumin < 35 g/L
An modified Glasgow Prognostic Score (mGPS) of 1 or 2 as defined below:
Previous surgery or radiofrequency ablation (RFA) to the liver is allowed; patients with history of chemoembolization or radio-labeled microspheres are excluded
Serologic documentation of HIV infection at any time prior to study entry, as evidenced by positive enzyme-linked immunosorbent assay (ELISA), positive Western blot, or any other federally approved licensed HIV test; alternatively, this documentation may include a record that another physician has documented that the participant has HIV infection based on prior ELISA and Western blot, or other approved diagnostic tests
Pts of all ethnic and gender groups will be included; protocol accrual will be reviewed annually to include a determination of minority and gender representation; if accrual demonstrates under-representation of any group with comparison to disease incidence in that group, then appropriate measures will be undertaken to attempt to increase participation of pts of that minority or gender group
Modified Glasgow prognostic score (mGPS) of 1 or 2 at Screening (randomized phase only)
External biliary drain
In addition to inclusion criteria listed for Part 1, Part 2 will enroll GCB-DLBCL tFL and MM subjects only. Relapsed and/or refractory MM or tFL that have failed prior standard therapy and for which there is no standard salvage regimen
Biopsy proven EBV(+) or KSHV(+) malignancy, including but not limited to:\r\n* EBV(+) non-Hodgkin lymphoma or lymphoproliferative disease\r\n* EBV(+) Hodgkin lymphoma\r\n* KSHV(+) Kaposi sarcoma involving skin, with or without visceral involvement\r\n* KSHV(+) primary effusion lymphoma\r\n* EBV(+) gastric cancer\r\n* EBV(+) nasopharyngeal cancer\r\n* EBV(+) leiomyosarcoma\r\n* KSHV(+) Castleman disease\r\n* Chronic active EBV
Involvement of one or more of the following organ systems (renal, neurologic, hematologic, cardiac, pulmonary, gastrointestinal) of moderate-to-severe severity as indicated by an “A” or 2 B score on the British Isles Lupus Assessment Group (BILAG), a 2 or higher on the Physician Global Assessment, or severe enough to require hospitalization if the organ involvement was not “captured” on either the BILAG or Systemic Lupus Erythematosus Activity Measure (SLAM) instruments
Total Symptom Score ? 13 on the MPN-SAF TSS 2.0, not including the inactivity question
Radiosensitizing doses of 5-fluorouracil;
An intraoperative MRI upon resection will confirm the distance of the planned injection sites from the ventricular system prior to the HSV1716 injection; intra-operatively, the neurosurgeon may decide to not inject the HSV1716 or may revise the sites of HSV1716 injection if injection cannot be guaranteed >= 1 cm from the ventricular system; patient will removed from the study if there are not sufficient areas in the tumor cavity to guarantee injection of HSV1716 >= 1 cm from the ventricular system
There is no available information regarding human fetal or teratogenic toxicities
Subjects whose primary physicians determine that anti-HSV antiviral therapy (such as acyclovir, ganciclovir, foscarnet, etc.) cannot be safely discontinued from 2 days prior to the injection to 28 days following the injection are excluded from this study
Patients with sickle cell disease and sickle cell crisis
Able to daily self-administer AMG 337 orally as a whole capsule
Subject's overall Beck Depression Inventory II Score is > 24 or has a score of 3 on question 9 relating to suicidal thoughts or wishes at the baseline visit
Sexual Health Inventory for Men (SHIM) score >= 17
Registered with Clinical Trials Office at Karmanos Cancer Institute/Wayne State University
Have extra-hepatic metastatic disease. Suspicious lesions should be rigorously evaluated with other imaging techniques and/or biopsy to exclude extra-hepatic metastatic disease prior to submitting for central radiology review.
Willing to refrain from drinking any kind of tea (including herbal tea) or using supplements containing green tea for the duration of the study
EUS clinically indicated for staging, and/or celiac neurolysis
Phase Ib: Documented evidence of PTEN mutations, homozygous deletion of PTEN or PTEN negative (H Score <10) by IHC confirmed by local or central assessment.
Phase II: Documented evidence of c-Met amplification (GCN>5) (fusion transcripts or mutant c-Met may be eligible after discussion with Novartis) or PTEN mutations, homozygous deletion of PTEN or PTEN negative (H Score <10) by central assessment.
On chronotropic drugs (acetylcholine, digoxin, diltiazem, verapamil, atropine, dopamine, dobutamine, epinephrine, isoproterenol)
Uncontrolled hypertriglyceridemia (> 450 mg/dL)
Unresectable stage IIIA or IIIB disease; patients must be surgically staged to confirm N2 or N3 disease; patients may have invasive mediastinal staging by mediastinoscopy, mediastinotomy, endobronchial ultrasound transbronchial aspiration (EBUS-TBNA), endoscopic ultrasound (EUS), or video-assisted thoracoscopic surgery (VATS)
Predominantly squamous, adenosquamous or unclear histologic type
Anticipated treatment of the index tumor that would require iceball formation within 1.0 cm of the spinal cord, brain, other critical nerve structure, large abdominal vessel such as the aorta or inferior vena cava (IVC), bowel, or bladder
Evidence of Gilbert's Syndrome or homozygosity for the Uridine 5-diphospho-glucuronosyltransferase (UGT) 1A1*28 allele
Presence of megakaryocyte proliferation and atypia, usually accompanied by either reticulin and/or collagen fibrosis, or, in the absence of significant reticulin fibrosis, the megakaryocyte changes must be accompanied by an increased bone marrow cellularity characterized by granulocytic proliferation and often decreased erythropoiesis (ie. prefibrotic cellular-phase disease)
Demonstration of JAK2617V>F or other clonal marker (e.g. MPL515W>L/K), or in the absence of a clonal marker, no evidence of bone marrow fibrosis due to underlying inflammatory or other neoplastic disease Minor Criteria
Leukoerythroblastosis
Palpable splenomegaly
At least 3 weeks must have passed since any of the following: systemic corticosteroids, immunotherapy (for example, interleukins, MCC vaccines, intravenous immunoglobulin, expanded polyclonal tumor infiltrating lymphocyte [TIL] or lymphokine-activated killer [LAK] therapy), pentoxifylline, other small molecule or chemotherapy cancer treatment, other investigational agents or other agents that target merkel cell carcinoma
Vagus nerve stimulator
Programmable shunt
Skull defect without replacement
Minimum pre-treatment online neurocognitive function (tNCF) score >= 70
Must demonstrate basic tablet skills, defined as the ability to open and close an application on the desktop of the tablet, and to be able to advance the screen by swiping left or right (required for the use of tNCF testing)
CHEMORADIATION:
HgbA1c of ? 7%
BNP or NT-proBNP within normal limits
Infected at time of protocol entry, or receiving antibiotics (other than prophylactic trimethoprim sulfamethoxazole)
Subjects are receiving ongoing treatment with AGS-003 in protocol AGS- 003-004 or AGS-003-006.
Obesity from a genetic cause (e.g., Prader-Willi)
PTCL-unspecified
Transformed mycosis fungoides (tMF)
CHOP 21
CHOP 14
CHOP + etoposide
Other CHOP variants: substitution allowed for 1 component with a drug of the same mechanism of action. Additional components, except alemtuzumab, are allowed. Rituximab may be added if not given within 3 cycles of randomization.
Men who are sexually active, including those with a pregnant partner, must agree to practice a medically acceptable barrier method contraceptive regimen (eg, condoms) while receiving pralatrexate and for 90 days after the last administration of pralatrexate.
Precursor T/NK neoplasms
Mycosis fungoides, except tMF
Prior exposure to pralatrexate.
Granulocytes >= 1500/ul
Patients with a history of second malignant tumor, other than the common skin cancers - basal and squamous carcinomas, within the past 3 years and uncertainty about the histological nature of the metastatic lesions; cases with other types of malignancies should be reviewed and decided by the principal investigator (PI) of the study
Have had prior radioimmunotherapy
Total lymphocytes count ? 0.5x10E9/L
Platelets count ? 100x10E9/L
Cervical intra epithelial neoplasia
Serum neutralization antibody assay shows >= 75% neutralization of the SS1 (dsFv) PE38 activity at 200 ng/ml
Patients with other cardiac diseases may be excluded at the discretion of the principal investigator (PI) following consultation with cardiology consultants
Other serious medical problem that in the view of the investigator makes therapy difficult to comply with or difficult to interpret toxicity
Other serious medical problem that in the view of the investigator makes therapy difficult to comply with or difficult to interpret toxicity
-  Adult patients with histologic verification of carcinoma of the pancreas (T1-3, N0-1)\n             who have undergone surgical resection within the past 4 - 12 weeks. Patients with R1\n             resections are excluded.\n\n          -  Must meet all laboratory safety criteria and not have active or history of autoimmune\n             disease or conditions, be treated with immunosuppressive drugs, or require the use of\n             systemic steroids. Primary intraoperative chemotherapy will be allowed.\n\n          -  Pregnant or nursing women will be excluded. Subjects with active infection, HIV,\n             Hepatitis B or C will be excluded.
Must be KRAS WT;
AKT INHIBITOR MK2206 ARM: Patients with diabetes or in risk for hyperglycemia should not be excluded from trials with MK-2206, but the hyperglycemia should be well controlled on oral agents before the patient enters the trial
LAPATINIB DITOSYLATE ARM: Previous lapatinib (lapatinib ditosylate) therapy
SUNITINIB MALATE ARM: Previous sunitinib (sunitinib malate) therapy
Patients with known syndromes that alter radiosensitivity
Has had end of trial visit in CS35 prior to approval of the CS35A protocol.
Ongoing use of an LH-RH agonist (or antagonist); patients who agree to stop LH-RH agonist therapy will be eligible but may need to wait until their required washout period is over; patients whose washout period is greater than 6 weeks will not be eligible; duration of washout period varies with the formulation of the LH-RH agonist being used and should be 2 weeks after the next dose would be scheduled; specifically:\r\n* For patients receiving a monthly formulations of LH-RH agonist, 6 weeks must pass from the last dose before eligibility;\r\n* For patients receiving a 3-month depot formulation of LH-RH agonist, 14 weeks must pass from the last dose before eligibility;\r\n* For patients receiving a 4- month depot formulation of LH-RH agonist, 18 weeks must pass from the last dose before eligibility;\r\n* For patients receiving a 6- month depot formulation of LH-RH agonist, 26 weeks must pass from the last dose before eligibility;\r\n* For patients with an annual LH-RH implant, 2 weeks must pass after removal of the implant before eligibility
Patients who received treatment with strontium-89 or samarium-153 are excluded, except prior samarium will be allowed provided it was administered > 1 year ago and/or the patient has demonstrated the ability to\r\nreceive cytotoxic chemotherapy without excess myelosuppression after receiving samarium.
More than 4 weeks must have elapsed since an surgical procedure at the time the patient receives the preparative regimen due to the inhibition of wound healing observed with VEGFR targeting angiogenesis inhibitors
Patients with diabetic retinopathy
Participants for whom front-line cytotoxic therapy is indicated (i.e. symptomatic visceral or pulmonary KS or symptomatic KS impairing functional status)
Expression of mesothelin must be confirmed by meeting 1 of the following criteria:\r\n* Mesothelin expression (> 10% of the tumor expressing mesothelin) by immunohistochemistry (IHC) \r\n* Elevated serum SMRP levels (> 0.4 nM/L)
Patients scheduled for elective thoracic surgery (segmentectomy, lobectomy or bi-lobectomy, pneumonectomy or esophagectomy) and meeting one of the four following risk criteria:\r\n* Female and B-type natriuretic peptide (BNP) >= 25 pg/ml (no age limit) \r\n* Male gender < 75 and BNP >= 25 pg/ml\r\n* Male- age >= 75 (No BNP limit)\r\n* History of prior AF
Patients in sinus rhythm
Sufficient physiological reserves
Deemed surgically resectable by a thoracic surgeon
Children are excluded from this study
Ability to understand and follow the breathing instructions involved in the respiratory gating procedure or to tolerate compression sufficient to reduce fiducial motion to =< 5 mm
Metastatic or locally recurrent EBV-positive, non-keratinizing and/ or undifferentiated NPC* who do not have curative options such as chemo-radiation or surgery *Subjects will be enrolled based on confirmed histology diagnosis of the NPC
Abnormalities of the cornea based on history (e.g., dry eye syndrome, Sjogren’s syndrome), congenital abnormality (e.g., Fuch’s dystrophy), abnormal slit-lamp examination using a vital dye (e.g., fluorescein, Bengal Rose), and/or an abnormal corneal sensitivity test (Schirmer test or similar tear production test)
Platelets >= 100,000/microliters
Must have undergone first-line treatment with a high-dose methotrexate-based chemotherapy regimen with or without brain radiotherapy; high-dose methotrexate is defined as >= 3 grams/m^2; methotrexate dose reduction for creatinine clearance < 100 ml/min is permitted
Patients with MPD
Expression of mesothelin must be confirmed by meeting one of the following criteria\r\n* Mesothelin expression (> 10% of the tumor expressing mesothelin) by immunohistochemical (IHC) analysis\r\n* Elevated serum SMRP levels (> 0.4 nM/L)
No evidence of TLS per the Cairo-Bishop definition of laboratory TLS (subjects may be enrolled upon correction of electrolyte abnormalities).
Agree not to share IP with another person.
Troponin-T value >0.4 ng/mL or BNP >300 pg/mL. Subjects with baseline troponin-T >ULN or BNP >100 pg/mL are eligible but must have cardiologist evaluation prior to enrollment in the trial for baseline assessment and optimization of cardioprotective therapy.
Part 2d: Patients with non GIST solid tumors with KIT mutations, who are TKI naïve or have been previously treated with KIT directed TKI therapy who are appropriate for KIT directed TKI therapy
Known or demonstrated wild type KIT or PDGF-R, or known or demonstrated mutations of PDGF R, SDH, or NF 1 that are causative for the observed malignancy.
Parts 2a and 2d: Patients with known or presumed pathogenic KIT exon 13 or 14 resistance mutations. (However, such patients are permitted on the combination arms of Parts 2b, 2c, 2e, or 2f.)
Hepatobiliary diseases including biliary tract diseases, autoimmune hepatitis, inflammation, fibrosis, or cirrhosis of liver caused by viral, alcohol, or genetic reasons. Gilbert's disease is allowed if total bilirubin is ?1.5 × ULN.
Eligibility of patients receiving any medications or substances known to affect or have the potential to affect the activity or pharmacokinetics of temsirolimus will be determined following review of their case by the Principal Investigator
NOTE: If both serum and urine m-components are present, both must be followed in order to evaluate response.
Diagnosed with relapsed or refractory NHL limited to subtypes listed below; the subject must have histologic confirmation of diagnosis according to review at the Cleveland Clinic Foundation, either at initial diagnosis or at any subsequent relapse; (biopsy is not required at relapse, but is suggested; biopsy at outside institution, reviewed at the Cleveland Clinic, is acceptable)
Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, or St John's wort, alfentanil, alfuzosin, almotriptan, alprazolam, amiodarone, amitriptyline, amprenavir, aprepitant, aripiprazole, bepridil, bortezomib, bosentan, budesonide, buprenorphine, buspirone, carbamazepine, cilostazol, cisapride, cyclosporine, delavirdine, didanosine, digoxin, disopyramide dofetilide, donepezil, eletriptan, eplerenone, fluticasone, fosamprenavir, galantamine, systemic griseofulvin, indinavir, levobupivacaine, lopinavir, midazolam, mifepristone, modafinil, nateglinide, nefazodone, nelfinavir, oxcarbazepine, pimozide, quetiapine, quinidine, repaglinide, rifabutin, rifampin, rifapentine, ritonavir, saquinavir, sildenafil, sirolimus, tacrolimus, tadalafil, tolterodine, theophyllines, tolterodine, triazolam, valdecoxib, vardenafil, ziprasidone, zonisamide, statins, with the exception of pravastatin (Pravachol) or other \statins\ which are not metabolized by or induce cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4), calcium channel blockers, Coumadin and macrolides or other agents that will be significantly perturbed in a clinically important way by the P450 inhibitory properties of ketoconazole
Patients on digoxin will be excluded from this study
Subjects with radiographic signs of excessive intra-cranial mass effect with associated rapid neurologic deterioration, and/or spinal block, are unsafe to undergo blood-brain barrier disruption (BBBD) chemotherapy and are not eligible
Moderate to severe cGVHD as assessed by NIH cGVHD Diagnosis and Staging Criteria (NCDSC) with at least three organ systems involved OR one organ system with a score of 2 OR lung organ score = 1
B cell depleting biologic agents
Serum cardiac troponin (cTn) level ? 99% percentile of the upper reference limit
Disease to be treated by ILI must be distal to the planned site of tourniquet placement (which for the leg is generally the apex of the femoral triangle, or for the arm is distal to the deltoid insertion); if provider feels ILI appropriate with disease in these areas, patients may be enrolled with principal investigator (PI) approval
Treatment with a thiazolidinedione PPAR gamma inhibitor; e.g. Actos® (pioglitazone) and Avandia® (rosiglitzone)
Fasting ?-CTX of >1000 pg/mL
Lactating females must agree to discontinue nursing before MMB administration
Patient shows evidence of diffuse alveolar hemorrhage or other active pulmonary disease, which is likely to require more than 2L of oxygen via face mask or an estimated FiO(2) of 28% via other delivery methods in order to sustain an O(2) saturation of 92%.
Patients whose AML is classified as favorable according to the European LeukemiaNet (ELN) disease risk assessment.
Glasgow Coma Score (GCS) of less than 15.
Asplenia.
NT-proBNP ?650
NT-proBNP >5000
Clinical diagnosis of acquired TTP (initial or recurrent), which includes thrombocytopenia and microscopic evidence of red blood cell fragmentation (e.g., schistocytes).
Symptomatic pericarditis.
Documentation of mucin 16 (MUC16) expression by either serum carcinoma antigen 125 (CA125) >=2 x Upper limit of normal (ULN) or by immunohistochemistry [IHC] by central review
Prior treatment with a monomethyl auristatin E (MMAE)-containing antibody-drug conjugate (ADC)
Patients must have demonstrated either disease progression or intolerance to imatinib mesylate, have non-mutant Stem Cell Factor Receptor gene (KIT) GIST, or cannot obtain imatinib in their country
Required used of folate-containing supplements (e.g. for folate deficiency)
Verification received from Argos Therapeutics that ribonucleic acid (RNA) successfully collected from TURBT procedure
Part B
For Part B only:
Basal cell carcinomas of aggressive subtypes (infiltrative, morpheaform, micronodular)
Have preexisting corneal disease that may interfere with assessment for potential eye toxicity during the study.
History of absolute decrease in LVEF of ? 16 absolute percentage points, or ? 10 absolute percentage points and crossing from > LLN to < LLN on prior anti-HER2 therapy, even if asymptomatic and the LVEF decrease recovered;
Hypersensitivity/infusion reaction to monoclonal antibodies, other therapeutic proteins, or allergy to any component/excipient of FS102 finished drug product (arginine, glycine, phosphoric acid, or polysorbate 80) and the reaction could not be controlled or prevented on subsequent infusion with standard therapies such as anti-histamines, 5-HT3 antagonists, or corticosteroids.
Symptomatic encephalopathy within 3 months prior to the first dose of TKM-080301 and/or requirement for medication for encephalopathy.
Able to begin extension study within 8 weeks of receiving 6th cycle of DI-Leu16-IL2
Treatment with a thiazolidinedione PPAR gamma inhibitor; e.g. Actos® (pioglitazone) and Avandia® (rosiglitazone)
Fasting ?-CTX of >1000 pg/mL
Complex/combined procedures (coronary artery bypass graft [CABG] plus valve), double/triple valve repair/replacements, ascending aorta/aortic arch surgeries (without baseline AT level restriction or preoperative heparin requirement). OR
Infective endocarditis.
Endogenous erythropoietin levels < 500 units/L
B12 and folate deficient patients with and without clinical symptoms (patients could be rescreened after successful therapy of B12 and folate deficiency)
Wash-out period:
Prior exposure to experimental treatment targeting either the hepatocyte growth factor (HGF) or Met pathway
Inclusion:\n\n          1. Received prior treatment with NKTR-102\n\n          2. Free of disease progression since receiving NKTR-102\n\n          3. Adequate bone marrow and organ function\n\n          4. Treatment with NKTR-102 in the extension study to begin within 8 weeks after receipt\n             of their of last dose of NKTR-102\n\n          5. Agree to use adequate contraception\n\n        Exclusion:\n\n          1. Treatment with other anti-cancer therapy between the last dose of NKTR-102 in the\n             prior study and before first dose of NKTR-102 in the extension study\n\n          2. A toxicity that requires a 3rd dose reduction after taking NKTR-102 or are scheduled\n             to receive a dose < 70 mg/m2 upon entry into this study\n\n          3. Pregnancy or lactation
Patients with small, localized intraocular Rb amenable to focal therapy (laser or cryotherapy) would be excluded, as they would not need systemic chemotherapy
Untreated SCCHN of oral cavity/soft palate, categories T1N1-2M0,T2N1-2M0,T3N0-2M0,T4N0-2M0 (T4 allowed only if invasion of mandible is negligible) scheduled for SOC
Tumor classifications T1N0, T2N0, T4N3, any TN classification with M1
Inclusion Criteria:\n\n        Entry criteria include the following:\n\n          1. Clinical diagnosis of VOD, made by Baltimore Criteria, Modified Seattle Criteria, or\n             biopsy proven:\n\n             1.1 Baltimore Criteria- Bilirubin ?2 mg/dL and at least 2 of the following clinical\n             findings:\n\n               -  Ascites (radiographic or physical exam)\n\n               -  Weight gain of ?5% compared to the day of conditioning-- if this value is not\n                  available, the weight on the date of admission to the SCT unit may be used)\n\n               -  Hepatomegaly; increased over baseline.\n\n             1.2 Modified Seattle Criteria: At least two of the following\n\n               -  Bilirubin ?2 mg/dL\n\n               -  Ascites (radiographic or physical exam) and/or weight gain ?5% above baseline\n                  weight (defined as weight on the first day of conditioning- if this value is not\n                  available, the weight on the date of admission to the SCT unit may be used)\n\n               -  hepatomegaly increased over baseline\n\n             1.3 Patients that do not meet the Baltimore Criteria or Modified Seattle Criteria and\n             have biopsy proven VOD are eligible.\n\n          2. Patient must also provide written informed consent.\n\n        Exclusion Criteria:\n\n          -  Use of any medication which increases the risk of hemorrhage is disallowed. Use of\n             heparin or other anticoagulants is disallowed within 12 hours unless being used for\n             routine central venous line management, fibrinolytic instillation for central venous\n             line occlusion, intermittent dialysis or ultrafiltration of CVVH.\n\n          -  Clinically significant uncontrolled acute bleeding, defined as hemorrhage requiring >\n             15 cc/kg of packed red blood cells (e.g., a pediatric patient weighing 20 kg and\n             requiring > 300cc of packed red blood cells/24 hours, or an adult patient weighing 70\n             kg and requiring >3 units of packed red blood cells/24 hours) to replace blood loss,\n             OR bleeding from a site which in the Investigator's opinion constitutes a potential\n             life-threatening source (e.g. pulmonary hemorrhage or CNS bleeding), irrespective of\n             amount of blood loss, at any point from the date of SCT through the date of severe VOD\n             diagnosis.\n\n          -  Hemodynamic instability as defined by a requirement for multiple pressors, or\n             inability to maintain mean arterial pressure (for children: to maintain mean arterial\n             pressure within 1 standard deviation of age-adjusted levels) with single pressor\n             support.\n\n          -  Woman who are pregnant.
Participants medicated with anti-depressants reported to have lysine-specific histone demethylase 1A (KDM1A)/lysine (K)-specific demethylase 1A (LSD1) inhibitory activity (such as tranylcypromine or phenelzine) within 28 days of treatment start
Failure to enroll and comply with Alliance A031201
Intention or plans for cyclophosphamide mobilization
On a gluten-free diet for at least 6 months
Other agents used strictly with palliative intent might be allowed during this period after discussing with principal investigator
No history of lumbar surgery or other pre-existing spinal conditions that would preclude frequent, safe, reliable lumbar punctures
Tumors with HER2 activating or other mutations including G309A, D769H, D769Y, V777L, P780ins, V842I, R896C, HER2 in-frame deletion 755–759, L755S, G309A, S310F, S310Y, V659E, R678Q, L755S, L755P, E757A, D769H, D769Y, A775_G776insYVMA, G776V, G776C, G776 insertions, V777L, G778_S779insCPG, P780_781insGSP, L841V, V842I, L869R, R896C, and any others identified where there is reported activity with neratinib
Patients must have a comprehensive geriatric assessment and chemotherapy toxicity assessment score between 7-17
Mitoxantrone >90 mg/m² and idarubicin > 70 mg/m².
Other definitive surgical procedures may be permissible upon the approval of the medical monitor OR
The two measurements are spaced at least 14 days apart;
CBC (except platelets and hemoglobin), serum chemistry, liver panel, and CPK values ? Grade 1 abnormality as defined in CTCAE v 4.03 dated June 14, 2010
No desire or plans to father new children during the study and/or have a prior vasectomy
Any pre-excitation syndromes, e.g., Wolff-Parkinson-White syndrome;
Member of vulnerable population including prisoners or mentally disabled patients, in accordance with U.S. Department of Health and Human Services (DHHS) definitions
Volume difference of at least 300 mL between the normal and lymphedematous limb based on perometry evaluation
Histologically documented diagnosis of myelofibrosis (MF) (idiopathic or post polycythemia vera [PV]/essential thrombocythemia [ET])
RAI-refractory disease on structural imaging
Disease that requires treatment based on the Investigator's opinion (e.g., meets GELF criteria)
Uncorrected coagulopathy:\r\n* Plavix usage at the time of vertebroplasty or history of taking Plavix less than 7 days prior to procedure (in selected cases, radiation treatment can be initiated, the antiplatelet agent stopped, and vertebroplasty performed after 7 days)
Asymptomatic vertebral fracture and low risk for biomechanical instability and collapse
Subjects with documented diagnosis of a type of sickle cell disorder who require RBC Exchange or RBC Depletion/Exchange treatment.
Medically stable subjects who have been previously treated for sickle cell disease with RBC Exchange or RBC Depletion/Exchange.
Procedures prescribed within one week of discharge of a hospitalization.
Known sensitivity to conductive hydrogels like the gel used on electrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes
Impending or actual pathological fracture of the humerus, secondary to metastatic bone disease.
In the investigator's judgment, functional deficit in the target humerus with an etiology other than bone metastases (e.g. due to vascular insufficiency).
Extremely comminuted fractures where insufficient holding power of the balloon on the intramedullary canal is probable.
Patients with unhealed surgical wounds for more than 30 days
Pathologic mediastinal staging to include endobronchial ultrasound with or without endoscopic ultrasound (endobronchial ultrasound [EBUS] +/- endoscopic ultrasound [EUS]) including evaluation of N3 nodes
International Association for the Study of Lung Cancer (IASLC) version 7, subset of stage IIIA single station (N2) disease; specifically T1a-T3, N2(+) with no invasion of key structures (e.g., chest wall or diaphragm)
Mediastinoscopy and/or endoscopic bronchial ultrasound (EBUS) and/or endoscopic ultrasound (EUS) for complete surgical staging when clinically indicated
Has recognized immunodeficiency disease, including cellular immunodeficiencies, hypogammaglobulinemia, or dysgammaglobulinemia, and/or other hereditary congenital immunodeficiencies
Embryonal or alveolar rhabdomyosarcoma
Dermatofibrosarcoma protuberans
Extraskeletal myxoid chondrosarcoma
Sarcomas arising from bone or cartilage, e.g. chondrosarcoma, osteosarcoma, chordoma.
Local conditions or systemic illnesses which would reduce the local tolerance to radiation treatment, such as serious local injuries, active collagen vascular disease, etc.
Disease is confined to locoregional site as confirmed by the CT and/or diagnostic staging laparoscopy to avoid occult peritoneal deposits; diagnostic laparoscopy will be only if absolutely required
Disease must be encompassed in a reasonable SBRT “portal” as defined by the treating radiation oncologist
Ineligible histology including non-adenocarcinomas, adenosquamous carcinoma, islet cell carcinomas, cystadenomas, cystadenocarcinomas, carcinoid tumors, duodenal carcinomas, distal bile duct and ampullary carcinomas
Abnormal T wave morphology (other than slight flattening)
Pathological U waves
Other QRS or T/U morphology preventing accurate determination of QT interval
Participants of North/East Asian ethnicity (ie, Japanese, Chinese, Korean) will be excluded.
Patient has a suitable MSD, volunteer MURD, or killer-cell immunoglobulin-like receptor (KIR) mismatched haploidentical donor available in the necessary time for stem cell donation
Subjects with EGFR-mutated lung cancer may continue erlotinib if they have been on the drug for >= 3 months with stable disease or a response; erlotinib may also be continued in the case of a progressing tumor after prior response (or > 6 months stable disease)
Any cardiac pre-excitation syndromes (such as Wolff-Parkinson-White);
Patients must have rearrangement involving the MLL gene, including reciprocal chromosomal translocations involving 11q23 by FISH, cytogenetic analysis, polymerase chain reaction (PCR) or next-generation sequencing (NGS) OR partial tandem duplication (PTD) of MLL by PCR or NGS.
Colonic prosthesis (stent) implant in place
Metastatic disease that involve major airways or blood vessels, or centrally located mediastinal tumor masses (< 30 millimeter from the carina) of large volume
No elevated biomarker (>ULN) that can be followed
chronic insomnia
Treatment related mortality (TRM) score < 22.9; patients with TRM scores > 13.1, in whom the risk of death within 28 days of beginning induction therapy has averaged 41%, will preferentially be placed on protocol 2642
Note, unlike pharmaceutical company sponsored protocols eligibility is not conditioned on bilirubin, creatinine, or absence of other malignancy within the past 2-3 years; the TRM score incorporates creatinine and thus a high creatinine can in principle be offset by favorable values for the other covariates in the TRM score; bilirubin was not a covariate in the TRM; furthermore, in the doses we are using, dose adjustment of decitabine or ara-C is not indicated in the presence of renal or hepatic abnormalities; our broad eligibility criteria may increase the likelihood that our results will be generalizable; the inability to reproduce results of early phase AML studies has been a problem in the past
Prior treatment with any agent targeting the hepatocyte growth factor (HGF)/c-Met pathway
Patients who are on a somatostatin analogue for control of hormonal syndromes must be on a stable dose (no change in mg dose of long acting octreotide or lanreotide, changes in dosing interval of +/- 1 week is allowed) for 2 months prior to date of study entry
Rapid central review confirmation of group D disease based on RetCam images from diagnostic EUA must be obtained before starting treatment
Unilateral retinoblastoma with group A, B, C, or E eyes
Capable of compliance with the requirements and restrictions listed in the consent form;
No later than 96 hours (h) in the immediate post-operative period; or
Multi-focal (defined as two separate areas of contrast enhancement measuring at least 1 cm in 2 planes that are not contiguous on either fluid-attenuated inversion recovery (FLAIR) or T2 sequences);
Associated with either diffuse subependymal or leptomeningeal dissemination; or
Progressed (> 25% increase in evaluable disease) or non-response on Revlimid or within 60 days of stopping Revlimid
Treatment with a thiazolidinedione PPAR gamma inhibitor; e.g. Actos® (pioglitazone) and Avandia® (rosiglitzone)
Fasting ?-CTX of >1000 pg/mL
Immunosuppressed patients
Substrates for p-glycoprotein transporter (e.g., ambrisentan, digoxin), OCT1 transporter (e.g., metformin), OAT1 transporter (e.g., captopril, furosemide, methotrexate), and OATP1B3 transporter (e.g., atorvastatin, rosuvastatin, valsartan);
Serological evidence of prior Epstein-Barr virus (EBV) infection as documented by positive immunoglobulin G (IgG) and negative immunoglobulin M (IgM) antibodies against EBV
DONOR: Serologic evidence of prior EBV infection as documented by positive IgG and negative IgM antibodies against EBV
Calculated panel reactive antibody (PRA) greater than 90%
Laboratory values: screening serum creatinine > 1.5xULN, ALT > 2.5xULN, total bilirubin > 1.5xULN, ANC < 1500/mm3, platelet concentrations < 100,000/mm3, absolute lymphocyte count < 1000/mm3, hematocrit level < 27% for females or < 30% for males, serum albumin ? 2.5 g/dL, PT/INR 1.5xULN or >3xULN on anticoagulant with no evidence of active bleeding.
Have prosthetic heart valves, major implant or device placed in the last 12 months or history of infection with implant/device that cannot be easily removed
Rapidly progressing disease
Valvular heart disease that requires antibiotic prophylaxis for prevention of endocarditis
An individual with an adrenal neoplasm less than 5 cm in size with biochemically confirmed evidence of hypercortisolism (2 out of 3: dexamethasone suppression test [DST] > 3 mcg/dL, elevated urine free cortisol, and/or morning adrenocorticotropic hormone [ACTH] < 2.2 pmol/l) without overt clinical signs and symptoms
Lack of metabolic complications
OR intolerant to second generation TKI and intolerant or refractory to imatinib mesylate
Medical history of Heart Failure (HF) with at least 1 prior hospitalization for HF or clinical evidence of HF (without hospitalization) manifested by signs or symptoms of volume overload or elevated intracardiac pressures (e.g., elevated jugular venous pressure, shortness of breath or signs of pulmonary congestion on x-ray or auscultation, peripheral edema) that required/requires treatment with a diuretic for improvement,
Evidence of cardiac involvement by echocardiography with an end-diastolic interventricular septal wall thickness > 12 mm,
Presence of amyloid deposits in biopsy tissue and presence of a variant TTR genotype and/or TTR precursor protein identification by immunohistochemistry, scintigraphy or mass spectrometry
Likelihood of death within 72 hours from any cause.
Patients must agree to provide all imaging studies for central radiology review; this central radiology review may be performed retrospectively and will not be utilized for decision making for patients on study
Not removed from trametinib treatment due to the development of unacceptable toxicity that is not manageable with dose reduction
experienced no dose limiting toxicity (DLT)
Patients enrolling on the retreatment cohort must have locally and systemically stable disease following the definite local treatment.
Known immunodeficiency disease, including cellular immunodeficiencies, hypogammaglobulinemia, or dysgammaglobulinemia; and/or other hereditary or congenital immunodeficiencies
Serious non-healing wounds or ulcers at the time of registration
Treatment with a thiazolidinedione PPAR gamma inhibitor; e.g. Actos® (pioglitazone), and Avandia® (rosiglitzone)
Fasting ?-CTX of >1000 pg/mL
For patients enrolling in this trial at Washington University School of Medicine (WUSM), it is required that WUSM patients must also enroll in Human Research Protection Office (HRPO)# 201111001; the genetic analyses for University of Florida (UF) patients will take place at WUSM under the auspices of this protocol
Paraneoplastic syndromes
ASS deficiency (defined as <50% ASS expression) demonstrated on tissue specimen by Immunohistochemistry (IHC). Cytology and fine need aspirate specimens are not acceptable for ASS testing.
Cutaneous squamous cell carcinomas (SCC) lesions identified at baseline must be excised; adequate wound healing is required prior to study entry; baseline skin exam is required for all patients
An EKG recorded at screening showing evidence of cardiac ischemia (ST depression of >= 2 mm, measured from isoelectric line to the ST segment); if in any doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not CAD is present
All pre-study labs required for determination of eligibility are to be completed within 30 days prior to day -2 (or the next business day if falls on a weekend or holiday)
Has had either partial or total gastrectomy
Patients with any gastrointestinal dysfunctions that could interfere with the interpretation of the food effect data
Patients with known intolerance to low or high fat meals
Sickle Cell Disease (HbSS, HbSC, HbS??-thalassemia, or HbS??-thalassemia)
If receiving hydroxyurea or erythropoietin, treatment must have been prescribed for at least 6 months, with the dose stable for at least 3 months
The need for treatment with medications with clinically relevant metabolism by the cytochrome P450 (CYP) 3A4 isoenzyme within 3 hours before or after administration of SNX-5422
Prior exposure to agents targeting either the Hepatocyte Growth Factor (HGF) or MET pathway
Patients who present for EGD with dilation for dysphagia symptoms thought secondary to either radiation-induced stricture or anastomotic stricture based on history
Endoscopic finding of a stricture that is not caused by either radiation or anastomotic narrowing
Nasopharyngeal strictures
Patients who are willing to refrain from donating blood for at least 90 days after their final dose of MLN4924 and (for male patients) willing to refrain from donating semen for at least 4 months after their final dose of MLN4924
Respiratory functions clinically stable for the preceding 3 months and expected to be stable for the next 3 months as determined by project principal investigators (PIs) and other pulmonary medicine faculty
One of the following known rare hereditary conditions: galactose intolerance, primary hypolactasia or glucose-galactose malabsorption
Patients with known endocrine disorders including, but not limited to, Cushing's, or Addison's disease; stable diabetes mellitus and hypothyroidism, which have been managed with the same medications at stable doses for the last 6 months are permitted
Treatment-related mortality (TRM) score >= 13.1 as calculated with simplified model
Intubated and mechanically-ventilated
Diagnosis of pneumonia defined as presence of a new or progressive infiltrate(s) on chest radiograph
Presence of Gram-negative organism(s) by either Gram stain or culture of respiratory secretions, or suspected Gram-negative pathogen
Presence of a multi-drug resistant (MDR) organism in a pre-therapy respiratory specimen OR at least two risk factors for MDR organisms
Known or suspected bacteremia secondary to Staphylococcus aureus
Patients receiving veno-venous extracorporeal circulation membrane oxygenation (V-V ECMO)
a GnRH analog is permitted if the patient had progressive disease on a GnRH (Gonadotropin-Releasing Hormone) analog plus a SERM (Selective Estrogen Receptor Modulators) or an AI; the GnRH analog may continue but the SERM or AI must be discontinued.
For the dose expansion cohorts: in addition to the above, there must be a difference between the amyloidogenic (i.e. clonal) and non-amyloidogenic light chain (dFLC) of at least 50mg/L (5mg/dL)
Amyloid cardiac biomarker stage III disease, defined as both NT-proBNP ? 332 pg/mL and troponin T ? 0.035 ng/mL. If troponin T is not available at local institution, troponin I may be used, but cut-off is ? 0.1 ng/mL
Pregnant women and breast feeding women are excluded from this study because of the risk to a fetus due to docetaxel chemotherapy and OGX-427 systemic treatment (fertility toxicology studies have not been completed for OGX-427).
Patients with known osteopenia or osteoporosis.
Patients must have received prior external beam radiation therapy to the region proposed for HDR brachytherapy treatment; evaluation of doses previously delivered to spinal cord/cauda equina, pelvis, and other critical structures (bowel, kidneys, rectum) will be taken into consideration\r\n* If repeat irradiation would exceed any normal tissue constraint set by Memorial Sloan Kettering Cancer Center (MSKCC) Radiation Oncology Department dose constraint criteria, the patient will potentially be eligible\r\n* If the total prior radiation dose to the cord or pelvis exceeds 100 Gy biological equivalent dose (BED) equivalent, the patient will be potentially eligible, where a total of 100 BED Gy equivalent is determined by the biological equivalent dose (BED) calculation
Patients with kyphoplasty cement or hardware that would preclude effective catheter placement
Require elective (non-emergency), open (non-laparoscopic), hepatic resection (anatomic or non-anatomic resections of at least one anatomical hepatic segment, or equivalent tissue volume).
Infection in the anatomic surgical area.
Application of any topical haemostatic material on the resection surface of the liver prior to application of study treatment.
Diagnosis of ?-thalassemia major and a history of at least 100 mL/kg/year of pRBCs or ?8 transfusions of pRBCs per year for the prior 2 years.
No response or loss of response to Erythropoiesis-Stimulating Agents (ESAs) or erythropoetin (EPO) > 500 mU/ml
Prior Exposure to Sotatercept (ACE-011)
Eligibility of patients receiving any medications or substances known to affect or with the potential to affect the androgen axis will be determined following review of their case by the principal investigator
Colorectal adenocarcinoma patients must be known to have CpG island methylator phenotype; CIMP-high phenotype will be defined as hypermethylation at 2 or more of the 6 methylation-specific polymerase chain reaction (PCR) markers (mutL homolog 1, colon cancer, nonpolyposis type 2 [hMLH1], cyclin-dependent kinase inhibitor 2A [P16], cyclin-dependent kinase 2 associated protein 2 [P14], amyloid beta (A4) precursor protein-binding, family A, member 1 [MINT1], amyloid beta (A4) precursor protein-binding, family A, member 2 [MINT2], and amyloid beta (A4) precursor protein-binding, family A, member 3 [MINT3])
Treatment-related mortality (TRM) score =< 9.2 as calculated with simplified model
Absolute lymphocytes > 500/mcL
History of osteonecrosis of the hip or have evidence of structural bone abnormalities in the proximal femur on MRI scan that are considered clinically significant or may have an impact on the interpretation of the scan. Degenerative changes of the hip joint are not exclusionary
Fevers >100.5º F or night sweats for more than 2 weeks without evidence of infection.
Allergic to fosaprepitant, aprepitant, ondansetron, or any other 5-HT3 antagonist
Ability to take oral medications (capsule must be swallowed with liquid)
Prior radioimmunotherapy
Participants must meet the inclusion criteria outlined in the respective parent protocols: NO21279 (NCT00623870), NO21280 (NCT00559533), NP25299 (NCT01164033), NP28021 (NCT01605526) or NP28023 (NCT01635296)
Participants must have completed one of the following clinical study protocols and have been determined to have clinical benefit on treatment at the conclusion of required study analyses as defined in the respective parent protocols: NO21279 (NCT00623870), NO21280 (NCT00559533), NP25299 (NCT01164033), NP28021 (NCT01605526) or NP28023 (NCT01635296)
Participants must meet the exclusion criteria outlined in the respective parent protocols: NO21279 (NCT00623870), NO21280 (NCT00559533), NP25299 (NCT01164033), NP28021 (NCT01605526) or NP28023 (NCT01635296)
If epidural catheter was used - the catheter must be removed prior to treatment
No clinical indication for a peritoneal port
Patients must have histologically confirmed thyroid carcinoma with the PAX8-PPARgamma translocation; refractory to radioactive iodine (RAI) as defined by: the tumor does not concentrate RAI; or the patient has had RAI within the last 16 months and has had progression despite that RAI; or the last RAI treatment was > 16 months ago and the patient progressed after at least two RAI treatments; or the patient has received RAI treatments with a cumulative RAI dose of >= 22.2 GBq (600 mCi) \r\n* Not a candidate for surgery or RAI therapy with curative intent \r\n* Lesions that would be treated by external beam radiation therapy (EBRT) based on standard of care can be so treated, but then cannot be used as target lesions unless there has been progression of the lesion since treatment
Confirmed parainfluenza at screening by one of the following methods using any sample type: Respiratory Virus Panel, Direct fluorescent antibody (DFA), Qualitative/quantitative RT-PCR test for parainfluenza virus performed at the local laboratory (a confirmatory PCR test will be done at the central lab but is not required to start the patient on study).
Confirmed PIV lower tract disease for subjects on mechanical ventilation will be defined as PIV detection in bronchoalveolar lavage (BAL) or biopsy within last 7 days of screening
Confirmed PIV lower tract disease for subjects on non-invasive positive pressure ventilation or supplemental oxygen will be defined as all of the following within the last 7 days of screening: New pulmonary infiltrate on chest imaging and at least one PIV sign and/or symptom as defined in section 10.3.6
Require therapeutic doses of any anti-coagulant.
2. If patient is in irPD (unconfirmed) status, they must not have had a decrease in their Karnofsky Performances Scale (KPS) score > 10 points and to be judged to not have \rapid clinical deterioration\ by the investigator since the subject's last tumor measurement leading to irPD assessment.
3. Currently in status of irPD (confirmed) or irPD (unconfirmed) without evidence of tumor inflammatory response, or with rapid clinical deterioration, or with a decrease of 10 points or more on their KPS score since their last assessment before irPD (unconfirmed) assessment.
The need for treatment with medications with clinically-relevant metabolism by the cytochrome P450 (CYP) 3A4 isoenzyme within 3 hours before or after administration of SNX-5422
Patients must not be receiving other investigational medications (covered under another IND) while on study.
Hematuria ? 1+ on urinalysis
To define DHL, patients must have evidence of C-myc (defined as: cytogenetic evidence [fluorescence in situ hybridization (FISH) or karyotype] of C-myc breaks [increased copy number in itself is not considered positivity for C-myc] OR positive IHC defined as >= 40% of the lymphoma cells staining for C-myc) PLUS either:\r\n* Breaks in BCL-2 via cytogenetic studies or\r\n* BCL-2 immunopositivity in >= 70% of lymphoma cells during phase I portion of the trial and >= 50% of lymphoma cells during the phase II portion of the trial
B3: Neurofibromatosis Type -1 associated plexiform neurofibromas (NF-1 with PN) that are unresectable and medically significant.
Must have recovered from the immediate post-operative period
Has leukaemia.
PHASE II: Measurability and suitability for volumetric MRI analysis of the target PN must be confirmed with the NCI Pediatric Oncology Branch (POB) prior to enrolling a patient; the target PN will be defined as the clinically most relevant PN, which has to be amenable to volumetric MRI analysis; PN will be classified as “typical PN” versus “nodular PN” versus “solitary nodular PN prior to enrollment
Willingness to avoid excessive sun exposure and use adequate sunscreen protection if sun exposure is anticipated
PHASE I: Patients who anticipate the need for surgical intervention within the first three cycles (3 months), as surgical intervention during the period of dose limiting toxicity (DLT) evaluation may affect analysis of adherence and/or make the subject inevaluable
Patients must have an Oncotype DX recurrence score < 18\r\n* If the patient does not already have Oncotype DX recurrence score, specimen (unstained blocks or slides) must be sent to the Genomic Health centralized laboratory in Redwood City, California; please see MA.39 trial specific website for instructions on ordering Oncotype DX test
Active adenovirus viremia
Need for vasopressor or ventilatory support
Have central confirmation of primarily non-enhancing disease by MRI with less than or equal to 5 mm slice thickness and up to 1 mm interslice gap on either 2D T2 weighted image, 3D T2 weighted image, or FLAIR, with at least 1 non-enhancing tumor measuring 1×1×1 cm.
Have received prior systemic anti-cancer therapy within 1 month of the first dose of AG-120 or AG-881 or have received an investigational agent <14 days prior to their first dose of AG-120 or AG-881. In addition, the first dose of AG-120 or AG-881 should not occur before a period of ?5 half-lives of the investigational agent has elapsed.
Patients must have either CA-125 in the normal range or CA-125 decrease by more than 90% during front-line therapy that is stable for at least 7 days (ie, no increase > 15% from nadir).
Known primary immunodeficiencies, either cellular (e.g., DiGeorge syndrome, T-negative severe combined immunodeficiency [SCID]) or combined T- and B-cell immunodeficiencies (e.g., T- and B-negative SCID, Wiskott Aldrich syndrome, ataxia telangiectasia, common variable immunodeficiency)
Resistance to/intolerance to hydroxyurea according to modified European Leukemia Net (ELN) criteria
Meets the criteria for post-PV myelofibrosis as defined by the International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT)
Metallic hip implant, metallic implant or device in the pelvis that might distort the local magnetic field and compromise quality of multiparametric (MP)-MRI
Requires ongoing hydroxyurea (hydroxyurea permitted up to first dose)
Only lucid patients qualified to consent to neurosurgical procedure will be approached for participation in this study
Patients that have clinically indicated intraoperative sensorimotor, or language mapping, will also have simultaneous (or tandem) i2DOS for functional brain mapping; 10 patients from each cortical mapping area will be imaged; optical maps will be compared to electrophysiological maps
No prior treatment with temsirolimus or an agent specifically targeting met proto-oncogene (c-Met)
Patients must have provided informed consent, be willing to have blood specimens taken, and exhibit no severe other medical or psychiatric problems
Combined major surgical cases that include a partial nephrectomy
Ongoing treatment with iniparib at time of parental study completion/closure and meet criteria to initiate a subsequent cycle of therapy, as described in the parental study protocol.
HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 ribonucleic acid (RNA) viral load; NOTE: The term “licensed” refers to a U.S Food and Drug Administration (FDA)-approved kit or for sites located in countries other than the United States, a kit that has been certified or licensed by an oversight body within that country and validated internally; WHO (World Health Organization) and CDC (Centers for Disease Control and Prevention) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment; a reactive initial rapid test should be confirmed by either another type of rapid assay or an E/CIA that is based on a different antigen preparation and/or different test principle (e.g., indirect versus competitive), or a western blot or a plasma HIV-1 RNA viral load
For immunoglobulin (Ig) A patients whose disease can only be reliably measured by serum quantitative immunoglobulin (qIgA) ? 750 mg/dL (0.75 g/dL).
Patients participating in the study must have metastatic (m)CRPC
Treatment within 30 days prior to enrollment with the following: cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, methotrexate, azathioprine, rapamycin, and targeted immune modulators such as abatacept (CTLA-4-Ig), adalimumab, alefacept, anakinra, belatacept (LEA29Y), efalizumab, etanercept, infliximab, or rituximab
The primary tumor of any T-stage\r\n* Is within or touching the zone of the “proximal bronchial tree” defined as a volume 2 cm in all directions around the proximal bronchial tree (carina, right and left main bronchi, right and left upper lobe bronchi, intermedius bronchus, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi), or\r\n* Within 1 cm of the mediastinal pleura but outside the proximal bronchial tree
Histologic proof of cancer for which no standard therapy is available, and which shows no staining for RB by IHC.
Requirement for anticoagulant therapy other than low intensity treatment to maintain patency of central venous catheters.
Centrally located, defined as located within 2 cm of the central bronchial tree (carina, right and left main bronchi, right and left upper lobe bronchi, bronchus intermedius, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi), major vessels (aorta, pulmonary artery trunk, left/right pulmonary artery/vein main branches, superior/inferior vena cava, brachiocephalic artery trunk or left/right brachiocephalic vein, left/right subclavian artery/vein), esophagus, heart, tracheal, pericardium, mediastinal pleural and brachial plexus, chest wall and vertebral body, but no direct invasion, stage I (T1-T2a =< 5 cm without main bronchus involvement), selective stage II (selective T3 with involvement of mediastinal pleura, parietal pericardium), based upon the following minimum diagnostic workup:\r\n* History/physical examination including weight and assessment of Zubrod performance status within 2 months prior to registration\r\n* Evaluation by an experienced thoracic cancer clinician within 2 months prior to registration\r\n* Computed tomography (CT) scan with intravenous contrast (unless medically contraindicated) of the entirety of both lungs and the mediastinum, most part of liver, and adrenal glands acquired within 2 months prior to registration must be available; the primary tumor dimension will be measured on the CT in lung window; if positron emission tomography (PET)/CT scan is performed within 2 months prior to registration, CT of chest is recommended but not required; whole body fluorodeoxyglucose (FDG)-PET within 3 months prior to registration with adequate visualization of the primary tumor and draining lymph node basins in the hilar and mediastinal regions and adrenal glands; pulmonary function tests (PFTs): routine spirometry, lung volumes, diffusion capacity (within 3 months prior to registration)\r\n* Patients with hilar or mediastinal lymph nodes =< 1 cm and no abnormal hilar or mediastinal uptake on PET will be considered N0; patients with > 1 cm hilar or mediastinal lymph nodes on CT or abnormal PET (including suspicious but non-diagnostic uptake) may still be eligible if directed tissue biopsy of all abnormally identified areas are negative for cancer; the primary tumor should be considered medically inoperable by an experienced thoracic cancer clinician for a standard lobectomy and mediastinal lymph node dissection/sampling procedure or patient refuses surgery; the patient may have underlying physiological medical problems that would prohibit a surgery due to a low probability of tolerating general anesthesia, the operation, the postoperative recovery period, or the removal of adjacent functioning lung; these types of patients with severe underlying health problems are deemed \medically inoperable;\ standard justification for deeming a patient medically inoperable based on pulmonary function for surgical resection of NSCLC may include any of the following: Baseline forced expiratory volume of the lung in 1 second (FEV1) < 50% predicted, postoperative FEV1 < 30% predicted, severely reduced diffusion capacity, baseline hypoxemia and/or hypercapnia, exercise oxygen consumption < 50% predicted, severe pulmonary hypertension, diabetes mellitus with severe end organ damage, severe cerebral, cardiac, or peripheral vascular disease, or severe chronic heart disease; if the patient has medically resectable/operable disease but declines surgery after consulting with a thoracic surgeon, he/she will be considered eligible
Patients currently taking drugs that are generally accepted to have a risk of causing Torsades de Pointes including: quinidine, procainamide, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, erythromycins, clarithromycin, chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide, cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine
Grade 2 or worse hypercholesterolemia or hypertriglyceridemia or >8% glycated Hb (HbA1C)
Any inflammatory changes of the surface of the eye
Greater than three prior recurrences
Prosthetic joint or other artificial implant or device that cannot be easily removed (there are some exceptions)
Recipient must have available the successful collection of a POL62326 mobilized product.
Subject discontinued ABT-806 or111ln ABT-806 (ABT-806i) administration before completing the prior study (due to disease progression, toxicity, withdrawn consent, other).
Non or minimally daily activities-interfering disease related symptoms.
Adequate bone marrow, renal, hepatic, and metabolic function (tests within normal limits or only minimally altered as assessed ? 7 days before inclusion in the study)Recovery to asymptomatic or minimally altered or to baseline from any adverse event (AE) derived from previous treatment (mild alteration for alopecia, skin toxicity or fatigue are allowed).
Has multicentric Castleman's disease
Patients cannot have had a second line salvage treatment (chemotherapy, biologic agents, investigational drugs, or radiation) or have had an autologous or allogeneic hematopoietic stem cell transplantation; patients can have had mixed frontline therapy such as 2-4 cycles of ABVD (doxorubicin, bleomycin, vinblastine and dacarbazine) followed by 2-4 cycles of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPP) as long as the induction chemotherapy is not more than 8 cycles in total length
Unhealed wounds (including active peptic ulcers)
Relapsed, refractory, or progressive Hodgkin’s lymphoma meeting one of the following criteria, and autologous BMT is not recommend:\r\n* PR or better prior to transplantation\r\n* Stable disease prior to transplantation, provided that the disease is low-volume and disease control is regarded as sufficient to proceed with BMT; eligibility of such patients will be determined on a case-by-case basis with the principal investigator (PI) or co-PI
Willingness to take everolimus orally, once daily at the same time every day either consistently with food or consistently without food
Mesenchymal, dedifferentiated, and extraskeletal myxoid chondrosarcoma subtypes.
Dedifferentiated
Myxoid
Round Cell
Pleomorphic - Leiomyosarcoma
Hypersensitivity to the active substance, or any of the excipients of the eribulin drug product, or dacarbazine, (please refer to the dacarbazine prescribing information).
Patients with unhealed wounds for more than 30 days
Patients with multifocal peripheral sensory alterations or paresthesias (including tingling) interfering with function, per patient report (example: activities of daily living)
Previous radioimmunotherapy (RIT) within 6 months of study entry. Subjects who have received RIT must have attained a PR or CR lasting at least 6 months, and must have recovered from any hematologic or other toxicity.
Positive immunohistochemical staining for WT-1 (greater than 10% of cells)
Patients with symptomatic cholelithiasis
Since zidovudine and stavudine have potential for severe hematological toxicity potentially overlapping with toxicities of the study therapy, treatment with these agents will be disallowed
Phase II : Diagnosis of recurrent, metastatic or primary unresectable ATC, including ATC as part of a thyroid carcinoma of another histologic subtype
Does not have:
Onset of influenza symptoms within 6 days prior to study enrolment. Symptoms may include cough, dyspnea, sore throat, feverishness, myalgias, headache, nasal symptoms (rhinorrhea, congestion), fatigue, diarrhea, anorexia, nausea and vomiting.
Clinical symptoms of influenza with positive influenza diagnostic test result or strong suspicion of influenza illness based on clinical symptoms and local surveillance information.
ALT or AST 3xULN and bilirubin 2xULN
ALT 5xULN
a. bortezomib
b. an IMiD
Can take oral med
Hx of ventricular arrhythmia or symptomatic conduction abnormality within 12m
Hx ventricular arrhythmia or symptomatic conduction abnormality within 12m
Cytopenias
Night sweats without signs of infection
No known contraindication to peripheral blood stem cell (PBSC) collection; examples of contraindications might be a weight or size less than the collecting institution finds feasible, or a physical condition that would limit the ability of the child to undergo apheresis catheter placement (if necessary) and/or the apheresis procedure
Patients must have failed (relapsed or refractory) front-line standard anthracycline-containing regimen, such as doxorubicin hydrochloride, bleomycin sulfate, vinblastine sulfate, and dacarbazine (ABVD), vinblastine, doxorubicin hydrochloride, vincristine sulfate, bleomycin sulfate, mechlorethamine hydrochloride, etoposide, and prednisone (Stanford V), or bleomycin sulfate, etoposide, doxorubicin hydrochloride, cyclophosphamide, procarbazine hydrochloride, and prednisone (BEACOPP)
Has radiologically documented evidence of major blood vessel invasion or encasement by cancer
Baseline cancer antigen (CA)-125 must be >= 70 units/mL
Patients with a CA125: carcinoembryonic antigen (CEA) ratio of < 25
Unable to attend to 2nd study visit at Stanford for Mohs surgical excision
For IgA patients whose disease can only be reliably measured by serum quantitative immunoglobulin (qIgA) ? 750 mg/dL (0.75 g/dL)
Tumor within or touching the zone of the proximal bronchial tree defined as a volume of 2 cm in all directions around the proximal bronchial tree (carina, right and left mainstem bronchi, right and left upper lobe bronchi, intermedius bronchus, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi)
Gender is not a criterion.
Hypotension requiring vasopressor support
Inability to achieve or maintain a minimum mean arterial pressure (MAP) of 65mmHg
There is clinical support for non-septic shock
Receiving concurrent treatment with prohibited medications (refer to Table 1 for details on prohibited medications); Examples include: ampicillin, antacids, cimetidine, cyclosporine, kaolin, magnesium trisilicate, coumarin-type anticoagulants, macrolide antibiotics (e.g., clarithromycin, isoniazid, and erythromycin), anti-HIV agents (e.g., ritonavir and delavirdine), antidepressants (e.g. fluoxetine and fluvoxamine), calcium channel blockers (e.g. verapamil and diltiazem), steroids and their modulators (e.g., gestodene, raloxifene, and mifepristone), and several herbal and dietary components (e.g. bergamottin and glabridin).
Intubated, mechanically ventilated, with respiratory failure secondary to diffuse, bilateral parenchymal lung disease (as judged by chest x-ray).
Arterial catheter placement
Glasgow Coma Score < 8 (prior to respiratory failure).
Patients with impending death from another disease.
hypotension unresponsive to treatment (mean BP < 60 or < 5th % for age),
persistent cardiac tachyarrhythmia >150/minute, or persistent bradyarrythmia < 50/minute, or age appropriate criteria for younger children,
hyperkalemia, serum K+ > 6.5 plus widening of QRS complex on EKG (QRS complex corresponds to the depolarization of the right and left ventricles of the heart).
Paraplegia
DONOR: History of prior malignancy; however, cancer survivors who have undergone potentially curative therapy may be considered for stem cell donation on a case-by-case basis; the risk/benefit of the transplant and the possibility of transmitting viable tumor cells at the time of transplantation will be discussed with the patient
Patients must be judged as being in a state of “no evidence of disease” at the time of enrollment; there is sometimes difficulty in definitively determining whether previously irradiated or surgerized sites are truly sterile, but the judgement should be based on standard imaging using the best judgment of the referring physician and Principal Investigator or her designee
Emotional limitations
Participants must not receive concomitant medications known to inhibit platelet function or known to selectively inhibit cyclooxygenase-2 (COX-2) activity (i.e., all antipyretic and anti-inflammatory medications except acetaminophen)
night sweats
Baseline laboratories (repeat labs can be evaluated at baseline to establish eligibility):
Known structural heart disease.
Interstitial brachytherapy: patients must have confirmation of true progressive disease rather than radiation necrosis based upon either PET or Thallium SPECT, MR spectroscopy and MR perfusion or surgical documentation of disease
Patients must be registered in the University of California at San Francisco (UCSF) Neuro-Oncology database prior to treatment with study drug
Patients must be willing to comply with the photosensitivity guidelines for a minimum of six weeks to be in the PDT treatment group (Group 1)
Paget's disease.
Treatment with nitrosoureas, such as carmustine (BiCNU), nitrogen mustard agents, or melphalan, within 6 weeks of first dose of elotuzumab.
1 A variety of other types of end organ dysfunctions can occasionally occur and lead to a need for therapy. Such dysfunction is sufficient to support classification as myeloma if proven to be myeloma-related.
Patients who have completed preceding gefitinib therapy from either the 1839IL/0709 (250mg dosing) study or 1839IL/0710 (250mg dosing) study and in the opinion of the investigator may benefit from further gefitinib treatment.
Withdrawal, at any time, from the preceding gefitinib study.
Adults or skeletally mature adolescents (ie, radiographic evidence of at least 1 mature long bone [eg, humerus with closed growth epiphyseal plate]) equal or greater than 12 years of age
Patients with familial adenomatous polyposis who have undergone subtotal colectomy with ileorectal anastomosis, total colectomy with ileo-anal pull through (reservoir), and patients with intact colons with 5 or more adenomas in the rectum-sigmoid or reservoir
Patients with familial adenomatous polyposis (FAP) and duodenal adenomatous polyposis without current lower tract adenomatous polyposis i.e. status/post (s/p) ileostomy
Patients with symptoms of active gastroesophageal reflux disease (GERD) (symptomatic despite medication or current erosive esophagitis on endoscopy)
Inability to give informed consent because of psychiatric problems, or complicated medical problems.
The PI and the Clinical Coordinator will be asked to verify that their referred patients do not have these exclusionary histories listed in 3.2 and a copy of this verification must be sent to the Sponsor before the Sponsor will approve of enrollment. Referring physicians will not need to sign. (Template for verification letter Appendix C).
Other serious co-morbid illness or compromised organ function.
Rapid diagnostic test, PCR, or viral culture positive for influenza in the 96 hours prior to first dose
Symptoms suggestive of influenza-like illness
Keratoconjunctivitis sicca or incompletely treated eye infection.
Have at least one of the following symptoms affecting sleep: a) not feeling refreshed on awakening b) difficulty falling asleep c) waking up during the night d) have difficulty falling back asleep at night after awakening e) waking up too early in the morning f) excessive sleepiness during the day
Participated or completed a GSK sponsored pazopanib study and remains eligible for continued treatment with pazopanib and lapatinib (if on combination therapy).
Diagnosis of other \congenital\ aplastic anemias such as: Diamond-Blackfan; Shwachman-Diamond; congenital amegakaryocytosis
Veno-occlusive disease, if present, should be stable or improving
History of orthotopic liver transplantation, clinical symptoms of portal hypertension, Whipple's procedure, hepatic artery anatomy incompatible with perfusion or known unresolved venous shunting
Patients diagnosed with Sezary syndrome; Sezary syndrome is equivalent to mycosis fungoides that develops to stage IVA/B with B2 (high blood tumor burden) involvement, and as such requires a more aggressive treatment regimen than Valchlor or TSEBT
Histological diagnosis of AL amyloidosis as based on detection by polarizing microscopy of green birefringent material in Congo red-stained tissue specimens; the type must have been confirmed unequivocally
NT-ProBNP > 8,500 pg/mL
Intrahepatic cholangiocarcinoma; a histological diagnosis is mandated; a diagnosis of adenocarcinoma with staining pattern consistent with cholangiocarcinoma and with a clinical presentation consistent with cholangiocarcinoma will be acceptable for enrollment as this is a typical intrahepatic cholangiocarcinoma presentation
History of biliary stent, internal biliary drain, or prior procedure compromising the ampulla of Vater (diagnostic endoscopic retrograde cholangiopancreatography [ERCP] is permissible)
Inoperable on the basis of co-existent medical problems
Patients must have a minimum of two metastases per hemithorax
Patients with other cardiac diseases may be excluded at the discretion of the principal investigator (PI) following consultation with cardiology consultants
Patients with active infections, including HIV, will be excluded, due to unknown effects DAC/THU on systemic immunity
Patients with a positive fecal occult blood test excluding hemorrhoids
Patients must have progressed on octreotide therapy and/or radioactive isotopes linked to octreotide or its congeners if they had a positive octreotide scan; patients who have negative or mildly positive octreotide scans are exempt from this requirement
Somatostatin analogs can be continued at their tolerated dose in patients with functional symptoms related to underlying disease such as in functional islet cell, insulinomas, glucagonomas etc
Patients may have received prior chemotherapy for advanced disease including either capecitabine or temozolomide single agent as long as it did not include combination of capecitabine and temozolomide
Granulocytes > 1,500/ml
Prior chemotherapy with combination of capecitabine (or 5-flourouracil [5-FU]) “and” temozolomide (or dacarbazine [DTIC]) will be excluded; patients can have had prior therapies up to 3 prior chemotherapy regimens such as streptozocin, anthracyclines, irinotecan, etoposide, or a platinum agent including single agent capecitabine (or 5FU) or temozolomide (or DTIC).
Patients must have a histologically confirmed diagnosis of primary myelofibrosis (PMF), post-polycythemia vera (post-PV) myelofibrosis (MF), or post-essential thrombocythemia (post-ET) MF using World Health Organization Criteria
Relapsed patients:\r\n* Second or greater relapse OR\r\n* AML in first relapse AND has received >= 450 mg/m^2 daunorubicin equivalents \r\n* NOTE: for the purposes of determining eligibility for this protocol, the following cardiotoxicity multipliers will be used to determine daunorubicin equivalents:\r\n** Doxorubicin: 1\r\n** Mitoxantrone: 3\r\n** Idarubicin: 3\r\n** Epirubicin: 0.5
Inability to obtain Foundation One testing on archival tissue, or, lack of previous Next Generation Sequencing incorporating testing for NOTCH -1, -2, -3, and -4
Is allergic to aminoglycoside antibiotics (such as gentamicin and/or streptomycin)
Have undergone clearance after baseline ophthalmologic exam (at least fundoscopic exam, visual acuity, intraocular pressure, assessment of visual fields and measurement of color vision)
Current evidence of corneal or retinal disorder/keratopathy including but not limited to bullous/band keratopathy, corneal abrasion, inflammation/ulceration, keratoconjunctivitis, confirmed by ophthalmologic examination
Patients with both variant alleles (*28/*28)
Patients with MF who are eligible for enrollment in the pacritinib “PERSIST-2” study at Washington University School of Medicine (WUSM) (NCT02055781) Human Research Protection Office (HRPO) 201406075
Active infection with Epstein-Barr virus (EBV) as defined as EBV viral load >= 10,000 copies per mL of whole blood; EBV viral load testing is only required if the patient has clinical signs or symptoms suggestive of active EBV infection
Significant (presumed) risk factors for toxicity due to IASA therapy including, but not limited to: major uncorrectable coagulopathy, bowel perforation, ongoing bacteremia, mesenteric insufficiency, are exclusionary; in these or any questionable cases, discussion with the PI is required
TSER genotype *2/*2
Patients with phaeochromocytoma
Receiving erythroid stimulating agents (erythropoietin [EPO]: Procrit, Aranesp)
Tumor located peripherally within the lung (peripheral defined as not touching any surface within 2 cm of the proximal bronchial tree in all directions) and not touching the mediastinal pleura
Patients with clinical symptoms consistent with active gastritis
Newly developed inoperable brain metastases (first occurrence) without associated hemorrhage or midline shift
No evidence of extraprostatic extension or seminal vesicle invasion by MRI,
Has no prostate calcification greater than 5 mm in the treatment zone, as noted by TRUS,
Requirement for immediate or urgent treatment with daily vemurafenib and for whom the intermittent schedule of vemurafenib employed during the 19-day period for this trial is not clinically acceptable
Patients who consume more than 3 alcoholic beverages per day
Patients on drugs that interfere with renal function or drugs that compete with tenofovir for active binding sites (i.e. intravenous cidofovir, acyclovir, ganciclovir, and valganciclovir)
Abnormal baseline Troponin-I.
Plan to treat with anastrozole for at least 12 months
No significant post mastectomy complications requiring an unplanned re-operation or admission for intravenous (IV) antibiotics; re-operation for margins evaluation, nodal completion and routine reconstruction is acceptable
Radiation oncologist intends to treat all target volumes and respect all normal tissues in accordance with the dosimetric constraints described (simulation before registration recommended)
Radiation oncologist is NOT planning to utilize a chest wall/scar boost
Antidepressants for mood and hot flashes, including selective serotonin reuptake inhibitors (SSRI’s) will be allowed if patients have been on a stable dose for the last 60 days and the dose is not expected to change during the course of the study; only subthreshold or low dose antidepressants will be allowed, not antidepressants that have been titrated up to the highest doses for depression management (i.e. Effexor 37.5 -75 mg or Lexapro 5-10 mg or Celexa 10 – 20 mg)
Have dementia
Have had treatment with an antipsychotic agent such as risperidone, quetiapine, clozapine, a phenothiazine, or a butyrophenone within 30 days before enrollment or plans for such treatment during the study period; NOTE: participants could have received prochlorperazine and other phenothiazines as antiemetic therapy on a short term basis (i.e., =< 5 days)
>= 6 score on the worst fatigue question of the BFI (Brief Fatigue Inventory, question 3); it is not required for the patient to complete the entire BFI to meet this criterion
Currently using any other pharmacologic agents or nonpharmacologic interventions to specifically treat fatigue, including psychostimulants, antidepressants, acupuncture, etc. will be excluded; Note: antidepressants used to treat items other than fatigue (such as hot flashes or depression) are allowed if the patient has been on a stable dose for >= 30 days prior to registration and plans to continue for the duration of the trial; erythropoietin agents to treat anemia are allowed; exercise is allowed
No other household member or relative participating in the study
A diagnosis of radionecrosis will be based on a clinical onset of symptoms and radiological findings of radionecrosis at 3-24 months following radiosurgery, with or without pathological confirmation
Symptomatic brain radionecrosis to at least one lesion following radiosurgery treatment for brain metastases where symptomatic is defined as:\r\n* New or increasing headache associated with mass effect, sensory or motor abnormality, cognitive changes, speech difficulty, balance or coordination difficulty, cranial nerve deficits\r\n* Symptoms are persistent or worsening despite administration of at least dexamethasone 4 mg daily for 1 week
No evidence of recent hemorrhage at pre-registration MRI of the brain, however the following are permitted: presence of hemosiderin, resolving hemorrhagic changes related to surgery, and presence of punctate hemorrhage in the tumor
Self-reported cognitive problem plus a measured memory deficit (score =< 7 on single trial of eligibility pre-screen Hopkins Verbal Learning Test-Revised [HVLT-R] form C)
Traumatic brain injury, multiple sclerosis, acute severe fatigue, chronic fatigue syndrome or fibromyalgia
Meet Diagnostic and Statistical Manual of Mental Disorders (DSM)-V criteria for insomnia and score >= 10 on the Insomnia Severity Index
Have practiced yoga >= 1 day a week within the 3 months prior to enrolling in the study
Residency in a rural zip code defined as below by the Rural-Urban Commuting Areas (RUCA) version 3.1; residential zip codes are assigned a RUCA code based on size of its largest population center and commuting patterns; a spreadsheet with eligibility by zip code will be provided to all participating sites\r\n* Rural: 4.0, 4.2, 5.0, 5.2, 6.0, 6.1, 7.0, 7.2, 7.3, 7.4, 8.0, 8.2, 8.3, 8.4, 9.0, 9.1, 9.2, 10.0, 10.2, 10.3, 10.4, 10.5, and 10.6
Residency in one of the following states: Georgia, Illinois, Minnesota, Missouri, New Mexico, North Carolina, North Dakota, South Carolina, Virginia, and Wisconsin
Self-reported psychotic symptoms in the last 30 days
Any change in psychotropic medications within the last 30 days
Receiving continuous oral 6MP during the maintenance phase of therapy for ALL (held only for toxicity or illness), and will be returning to the clinic every 4 weeks for scheduled appointments while enrolled on COG ACCL1033 (between days 1 and 141)
All patients must have undergone a cone biopsy or loop electrosurgical excision procedure (LEEP); depth of invasion must be =< 10 mm
Patients with depth of invasion > 10 mm on first cone biopsy (or LEEP)
Have at least one geriatric assessment domain meet the cut-off score for impairment other than polypharmacy
Patients must not be registered to step 2 until receiving confirmation from the ECHO Core Lab that the patient’s LVEF by echocardiogram was >= 50% by central review; patients must be registered within 5 calendar days of receiving the e-mail notification
KEY INFORMANT: Member of the lung cancer screening team who is (or would be) responsible for implementation and/or supporting smoking cessation support for patients receiving lung cancer screening; this will include the program champion (intervention clinic only) and is likely to include: imaging facility program directors, health care providers (e.g., physicians, radiological technicians), and other staff (e.g., receptionist); coordinators of centralized services for tobacco cessation at the component/subcomponent would also be eligible
KEY INFORMANT: Agrees to have the interview taped, transcribed and qualitatively analyzed
Caregivers that are illiterate will be excluded from this study
The following baseline neurocognitive assessments must be completed and uploaded prior to step 2 registration: HVLT-R (recall, delayed recall, and recognition), TMT parts A and B, and COWA; the neurocognitive assessment will be uploaded into a folder in the NRG Medidiata RAVE System for evaluation by Dr. Wefel; once the upload and scoring of the tools are complete, a notification will be sent within 3 business days to the research associate (RA) to proceed to step 2; in order for the patient to be eligible, at least 5 of the 6 neurocognitive assessments must be able to be scored (i.e. free of any errors)
Completion of all items on the following baseline quality of life forms: MDASI-BT, LASA QOL, WPAI-GH and Employment Questionnaire; these quality of life forms will be required and data entered at step 2 registration
Have chronic nausea that has been present for at least one week (worst daily score > 3, 0-10 visual analogue scale) or vomiting at least five times over past one week
Women with laparotomy incisions left open due to case classification as \contaminated\ or \dirty\
Women with laparotomy incisions unable to be closed primarily due to tissue or fascial damage
Live within one hour commuting distance to the center where they were recruited
Flap coverage or skin graft
Paid employment (full time or part time) at time of consent
Has a smartphone (iPhone or Android)
Has low confidence in requesting workplace accommodations (based on a brief screening survey). Low confidence is defined by having a score of 7 or lower on any of the five measures
Patients having any immediate reconstructive procedure
Patients will be excluded if they are having their mastectomy performed with tumescence
Requirement of assistive devices (e.g., cane) for ambulation
Have their own e-mail address, or be willing to sign up for a new one
Not in a committed relationship for at least 6 months
Patients with painful metastases to hands and feet that need to be radiated on protocol
Salvage RC
Must be able to perform basic activities of daily living (as determined by referring study recruiter at intake)
A text messaging plan that includes a minimum of 150 text messages a month at no additional cost
Orthopedic, neurologic, or musculoskeletal disability that would interfere with the functional task of standing on a weight scale
Consented to enroll in a trial with a toxicity endpoint
TEMPLATE MODIFICATION:
Myasthenia gravis or other neuromuscular disease
Incarcerated individuals or individuals detained within the legal system
Life expectance of at least three months
Beginning a new course of chemotherapy and/or immunotherapy (with a side effect profile that includes the symptoms monitored by SCH) that is planned for a minimum of three cycles
Score in the range of 'very low' or 'low' food security status on the United States Department of Agriculture (USDA) Household Food Security Module (score of 3 or higher)
Living independently (no patient in an assisted living facility) in New York City (NYC)
CLINICIAN: Has a Doctor of Medicine (MD) or Doctor of Osteopathic Medicine (DO) degree
Commit to the STOP Program by completing the online course and sharing lessons learned with other CCPs at the monthly virtual meetings that will take place during the 6 months following course completion
Documentation of a low-risk PCa diagnosis as evidenced by clinical features of the\r\nfollowing criteria:\r\n* PSA test at diagnosis =< 15 ng/ml\r\n* Localized PCa (cT1/T2,N0,M0)\r\n* Biopsy Gleason grade 2-6 OR (or 3+4 AND <=33% cores are positive for adenocarcinoma)\r\n** A minimum of 10 diagnostic cores taken by a systematic directed approach. Sampling may be obtained by target transrectal ultrasound (TRUS) or magnetic resonance imaging (MRI) imaging.\r\n* No treatment yet\r\n** No previous radiation or simultaneous use of androgen deprivation\r\n** Prior use of 5-alpha reductase inhibitor is allowed if they have been stopped for 6 or more months and biopsy performed when patient was not\r\ntaking the drug\r\n* English language proficient and ability to provide informed consent form (ICF)\r\n* Managing urologist considers them a candidate for active surveillance
CHILD: Child understands English and is enrolled in school (but can be bilingual)
Self-reported shortness of breath (a score of 2 or greater on the Modified Medical Research Council Dyspnea Scale)
Able/willing to have an online interaction with a Reimagine Pillar Guide
CLINICAL STAFF: Primary care physicians, radiation oncologist, medical oncologist and other providers (i.e. nurse practitioners, navigator, social worker etc.) who refer patients to thoracic clinic will also be recruited for interviews about delivery of tobacco treatment services
Individuals with diminished mental capacity
Children
Individuals with diminished mental capacity
Prior exposure to radium-223
Received systemic therapy with radionuclides (e.g. strontium-89, samarium-153, rhenium-186 or rhenium-188) for the treatment of bone metastases
Targeted bone/tumor interface are ExAblate device accessible and are located in ribs, extremities (excluding joints), pelvis, shoulders and in the posterior aspects of the following spinal vertebra: Lumbar vertebra (L3 - L5), Sacral vertebra (S1 - S5)
Need surgical stabilization of the affected bony structure (>7 fracture risk score, see Section 7.4) OR
Platelets (plts) > 90,000
Reside in a non-metro county of the United States according to the United States Department of Agriculture (USDA) Rural-Urban Continuum Codes (6 -9) (RUCC) or at a rural zip-code by the USDA Rural Urban Commuting Area (RUCA) codes (10.X)
Patients with advanced cancer who are receiving treatment at Dana-Farber Cancer Institute (DFCI) in the thoracic oncology group and the DFCI-affiliated St. Elizabeth’s Hospital
High anxiety score (>=15/21) on the Hospital Anxiety and Depression Scale (HADS).
Confounding underlying medical illnesses which may cause fatigue (e.g., severe anemia not controlled by medication, per self-report corroborated by medical chart review (e.g., hemoglobin [Hb] < 10gm/dl))
Eye diseases which limit the ability of light to be processed (e.g., untreated cataracts, severe glaucoma, macular degeneration, blindness, pupil dilation problems or retina damage)
Lives outside of the United States throughout duration of study
Has private insurance, or covered by Medicare or Medicaid
Actively practicing mindfulness meditation
Be a resident of the United States of America
Fibrinogen ? 100 mg/dL
Planned administration of bedside LR PLT transfusion(s)
This study was designed to include women and minorities, but was not designed to measure differences between them; males and females will be recruited with no preference to gender; minorities will actively be recruited to participate; no exclusion to this study will be based on race
Patients must be >= 6 months from craniotomy
Patients who, based on the physician’s opinion, are unable to participate in neurocognitive testing and/or neurocognitive rehab secondary to significant neurologic deficit
Race: African-Americans and non-Hispanic whites
Able to perform basic activities of daily living (ADLs)
Able to hear normal conversation
Reporting a severity of 3 or higher on fatigue using a 0-10 standardized scale at intake.
Bedridden
Self-reported sleep duration of 6 hours per night or less
Endorses fatigue as determined by eligibility screening and a score of < 43 on Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F)
Being evaluated or likely to be evaluated for a medical cause of fatigue (e.g., anemia, hypothyroidism) during the study; (per provider report)
For aim 3: Receiving CTX for a cancer diagnosis on a 7, 14, or 21 day schedule with the CTX dose given on day 1
Has subjective sleep disturbance (i.e., a self-rated score of fairly bad or very bad on question 13 of the Pittsburgh Sleep Quality Index [during the past month, how would you rate your sleep quality overall? 0=very good; 1=fairly good; 2=fairly bad; 3=very bad])
Families of all children < 17 years of age admitted to the hospital during the study period who screen positive for secondhand smoke exposure
Families of all children who are in the hospital for >= 24 hours
Patients already meeting the criteria for metabolic syndrome as defined by the Adult Treatment Panel III criteria which requires 3/5 parameters encompassing glucose control, blood pressure, lipids and waist circumference; patients with 2 of the parameters at baseline will be allowed enrollment provided that one of those risk factors is hypertension (>= 130/>= 85 mm Hg)
Patients must have confirmed and measurable sickle cell disease, defined by sickle cell anemia (SS) or sickle beta (SB) thalassemia confirmed by hemoglobin fractionation
Patients with type I hypersensitivity reactions to chemotherapy agents including, but not exclusive to, platins, taxanes, or monoclonal agents as evidenced by typical immunoglobulin (Ig)E-mediated symptoms (ie. flushing, hives, dyspnea, wheezing, nausea, itchy eyes, nasal congestion, hypotension, angioedema) or tryptase level elevated above baseline during an infusion reaction\r\n* For various reasons, some, but not all, patients enrolled in the desensitization program may not have positive skin test data to confirm an IgE-mediated reaction; these reasons include 1) cutaneous toxicity of the drug precluding testing, 2) limited sensitivity of skin testing for the drug being tested, 3) lack of adequate testing reagent and controls
Patients with breakthrough reactions requiring multiple desensitization interventions including failed 16-step protocols or intervention with additional antihistamine (requiring > 50 mg of short-acting 1st-generation antihistamine – i.e. diphenhydramine or hydroxyzine -or > 10 mg of long-acting 2nd generation antihistamine – i.e. cetirizine or loratadine)
Concurrent diagnosis of organic brain syndrome, dementia, mental retardation, or significant sensory deficit
Have high grade squamous intraepithelial lesion (HSIL) of the vulva (VIN2 or VIN3) caused by infection with HPV types 16 and/or 18 confirmed at screening visit;
Allergy to imiquimod 5% cream or to an inactive ingredient in imiquimod 5% cream;
Others:
Willingness to avoid exposing breast skin to natural or artificial sunlight (i.e. tanning beds) for the duration of the study
DCIS presentation as a palpable mass
Subject has a diagnosis of high grade myxoid liposarcoma / myxoid round cell liposarcoma confirmed histologically and by the presence of the reciprocal chromosomal translocation t(12;16)(q13;p11) or t(12; 22) (q13;q12)
Subject has advanced (metastatic or inoperable) high grade myxoid liposarcoma / myxoid round cell liposarcoma. Inoperable refers to a tumor lesion in which clear margins cannot be obtained without leading to significant functional compromise
Disease must be clinically limited to the esophagus or GEJ; GEJ tumors must be Siewert type I-III
Patients must have surgically resectable disease treatable by esophagectomy, as assessed by a thoracic surgeon
Others:
Permanently discontinued from any Medivation sponsored study with talazoparib alone or in combination with another agent.
Active infectious disease considered by the Investigator to be incompatible with the protocol.
Patients with up to two recurrences are allowed.
Skull defects such as missing bone flap, a shunt, or bullet fragments.
Prior adverse reaction to tetanus toxoid-containing vaccines
Have previously completed or withdrawn from this study or any other study investigating prexasertib or a checkpoint kinase I (CHK1) inhibitor or have shown hypersensitivity to any of the components of the prexasertib formulation
Currently has a condition that could compromise or complicate wound healing. Note, obesity alone is not an exclusion. All surgical risk factors (obesity, diabetes, smoking history, and prior radiation) should be considered in totality for proper subject selection
Infection or abscess anywhere in the body
Works for Mentor or the study doctor or is directly related to anyone who works for Mentor or the study doctor
They are already receiving PC or hospice services
Self-reported ability to walk 400-meters (approximately one city block) without sitting, leaning, or the help of another person or walker
Estimated intelligence at least 80 (standard score)
Demonstrated attention difficulties (T-score of at least 65 on attention questionnaire or 1 or more standard deviations below mean on direct attention measures)
Patients with implantable drug delivery systems, e.g. Medtronic Synchromed
Experience ? 2 concurrent symptoms (fatigue, sleep disruption, depressive symptoms, and/or cognitive dysfunction as measured by 4 screening instruments)
Be either phase advanced or delayed (morning or evening types by the Horne-Ostberg Morningness-Eveningness Questionnaire [MEQ] ? 59 or ? 41)
Sighted
Are engaged in shift work or travel across more than three time zones within 2 weeks prior to study
Report severe depressive mood (Center for Epidemiological Studies Depression Scale [CES-D] > 24)
Take prescribed sedative hypnotics or steroids; individuals who have eye conditions (glaucoma or retinal disease), problems triggered by bright light (e.g., migraine), or take photosensitizing medications (e.g., some porphyrin drugs, antipsychotics, antiarrhythmic agents) will be excluded for safety of using bright light
A history of at least moderate CRF over the past month as defined by a CRF score of 4 or more on a 0-10 numerical rating scale
Participants who are deemed qualified for yoga movements according to the Yoga Qualifying Movements Screening Checklist (a checklist developed by researchers at the University of California, Los Angeles to promote yoga safety through assessing the eligibility of each patient)
Has a minimum appointment time of 60 minutes
Individuals with visual impairment or blindness will be excluded
Current smokers who would like help quitting (? 5 cigarettes per day and/or have a breath carbon monoxide [CO] reading of ? 8 parts per million [ppm)]
Able to engage using at least one of the intervention formats
People who self-report having a severe mental illness
Significant insomnia as evidenced by an Insomnia Severity Index score >= 12
Prior attempt(s) to treat insomnia using cognitive-behavioral treatment for insomnia
Employment that involves irregular sleep patterns, such as shift-work or frequent long-distance travel that involves adjusting to different time zones, or employment in a position that could impact public safety (such as operating heavy machinery)
Patients must be indicated for major head and neck surgery, defined as surgeries with an anticipated post-surgical hospital stay of 4 or more days; examples of major surgeries include, but are not limited to, total laryngectomy, large oral cavity, oropharyngeal, salivary gland, or soft tissue resections requiring free flap or major regional flap (e.g. pectoralis major flap), and large skull base procedures requiring extensive skull base reconstruction
FCG is willing and able to consent and travel to the class location for 6 weekly 2-hour sessions
Currently treated with any of the following contraindicated medications:\r\n* Saquinavir, Lopinavir, Amprenavir, Atazanavir, Delavirdine \r\n* Mexiletine (and other types of sodium-channel blocker antiarrhythmics)\r\n* Phenytoin, Carbamazepine, Oxcarbazepine, Lamotrigine\r\n* Amiodarone \r\n* Dronedarone \r\n* Dihydroergotamine \r\n* Cimetidine
Self-reported completion of at least an eighth-grade education
Post lumpectomy or mastectomy
Self-report of moderate to high levels of stress using the Perceived Stress Scale
Have confirmed LE based on bioimpedance measurements with an LDex score of > 7.1 (which corresponds to a bioimpedance resistance ratio of 2 standard deviations [SD] above normative values)
Be able to attend the sessions at the University of California, San Francisco (UCSF) Parnassus campus
Have a condition that precludes measurement of LE using bioelectrical impedance spectroscopy (BIS), including pregnancy
Compromised immunity
Who underwent or who will undergo lung resection at Brigham and Women’s Hospital (BWH)
Anaphylaxis to local anesthetics or narcotics
Patients with previous ventral hernia repair, cosmetic abdominoplasty or anterior abdominal wall reconstruction
Participation in qualitative interview during phase 1 (Dana-Farber Harvard Cancer Center [DF/HCC] 16-396)
PHASE 0: Unable to stand and walk unassisted at time of recruitment. Non-English speakers are excluded because activity prompts to disrupt sedentary behavior will be given in English only
PHASE 1 & 2: Unable to stand and walk unassisted at time of recruitment. Non-English speakers are excluded because activity prompts to disrupt sedentary behavior will be given in English only
All races and ethnicities will be included.
Eye Diseases which limit the ability of light to be processed (e.g., untreated cataracts, severe glaucoma, macular degeneration, blindness, pupil dilation problems or retina damage)
Focus groups consisting of men who live, work, or worship in the 4 predetermined neighborhoods
Treatment with psychotropic medication (psychostimulant, antidepressant, anxiolytic, antipsychotic) within the past two weeks, unless being prescribed specifically as an anti-emetic
Brief Fatigue Inventory (BFI) score > 25
Inability to lay supine for one hour at a time, given the nature of the massage intervention
Subjects currently employing any other complementary and alternative medicine (CAM) manual therapy and/or holistic therapies to treat a perceived health problem; however, since past experience with CAM therapies should not confound any of the analyses of the experiments proposed in this study, we will not exclude individuals who have engaged in a CAM manual therapy in the past, nor will we exclude individuals who practice yoga or meditation for well-being, take vitamins or use nicotine
Subjects must have intact preoperative erectile function, sufficient for penetrative intercourse without medication nor assistive device, as defined by a Sexual Health Inventory for Men/International Index of Erectile Function (SHIM/IIEF)-2 score 22 or higher, which is collected as part of routine care.
Lack of successful intraoperative nerve sparing.
Intractable vomiting
Any histologic subtype
No vascular invasion or resection/repair/reconstruction that results in decreased perfusion of the extremity
Vascular invasion or resection/repair/reconstruction that results in decreased perfusion of the extremity
The following exclusion criteria will avoid the possibility of preexisting muscle impairment: history of congenital myopathies; neurologic disorder involving sequelae of spinal derangement; disk disease; tremor and rigidity
Reports moderate fatigue on most days within the past week (i.e., at least 4 out of the last 7 days), rated as >= 4 on a 0 (no fatigue) to 10 (worst fatigue) scale
Depression or anxiety as defined either by ongoing pharmacological treatment for depression or anxiety or a Hospital Anxiety and Depression Scale (HADS) score >= 11 on initial screening; those individuals taking psychoactive medications for treatment of hot flashes are eligible if they have been on a stable dose for at least three months
Hairstyles that obstruct placement of the electrodes including cornrows, dreadlocks, braids or other hair accessories that cannot be removed
Residing in an institution or other living situation where health care decisions are not made by the participant (e.g., hospitalized, prisoners, living in a rehabilitation facility)
Concurrent liposomal doxorubicin or any other liposomal agent
PATIENTS: Regularly (self-defined) participated in a yoga practice in the year prior to diagnosis.
Live within a 1 hour commuting distance from Rutgers Cancer Institute of New Jersey
Subjects with a diagnosis of differentiated thyroid cancer who have undergone total or near-total thyroidectomy and are candidates for iodine I-131 (I-131) treatment at Thomas Jefferson University Hospital (TJUH) are eligible to participate
Subjects who have had emesis or required antiemetics in the 48 hours prior to starting the BEAM conditioning regimen; also patients required to take antipsychotics, appetite stimulants, or other medications with antiemetic effects will be excluded if those medications cannot be replaced by therapeutic equivalents
Subjects on strong CYP 3A4 inducers or inhibitors who are unable to have those agents replaced with clinical alternatives prior to beginning the study; length of washout period will be 7 days; notably, in the case of allogeneic transplant recipients requiring cyclosporine or tacrolimus, no empiric dose adjustments will be required due to close level monitoring and adjustments, which are standard in Oregon Health & Science University (OHSU) protocols
Subjects unable to discontinue benzodiazepines will not be allowed as hypnotics; additional antiemetics will be allowed for rescue but not for prophylaxis
Be first-generation immigrants
Who are using acupuncture
Skull or bony defect in the area contacting the immobilization straps
RT delivered by clinical setup only (no CT simulation)
Required laboratory parameters: Patients able to adequately perform pulmonary function testing per American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines, as determined by the enrolling investigator and trained respiratory therapists
Inability to perform pulmonary function testing (PFT), as determined by the enrolling investigator or PFT lab
Patient must be opioid-tolerant (greater than or equal to 60 mg morphine or equivalent) and on a stable dose of oral opioids for greater than or equal to 1 week; stable baseline opioid dosage defined as a dosage that does not fluctuate by more than 50% from the average dosage over one week prior to screening
Patient is thought to be at risk for misuse, abuse, addiction or overdose for schedule II controlled substance, as evidenced by the following:\r\n* An Opioid Risk Tool (ORT) score of greater/less than or equal to 8.2 \r\n* A review of the California Prescription Control Monitoring Program (PDMP) Controlled Substance Utilization Review and Evaluation System (CURES) report demonstrates multiple prescribing providers and/or multiple pharmacies in the last 30 days; the CURES report will also be used to verify opioid use, opioid dose, and current prescribing providers
Workshops B and C (2018 - 5 weeks - City of Hope)\r\n* Cancer patients (all types and at any time point in their disease)\r\n* Note: documentation to confirm this eligibility criteria will not be requested; self-reporting as a cancer patient will be considered adequate
CHILDREN
Parents and co-parents selecting the telephone version of the intervention may live any distance from the University of Washington
If any member of the triad retracts consent or assent prior to completion of the post-intervention surveys, then all members will be excluded from the study thereafter
The child will be excluded if he or she has learning challenges as assessed by the patient or co-parent; patients and co-parents will be instructed to consider any formal diagnoses of a learning disability of the presence of an Individual Education Plan (IEP) when making this assessment
Must agree to take progestin agents (i.e., oral agents or MIRENA intrauterine device [IUD] which are accepted treatments for low grade uterine malignancies to control their disease while the intervention is ongoing)\r\n* Note: potential participants WILL NOT be asked to delay surgery to participate in this pilot study
Travel distance greater than 50 miles
Presence of fatigue on FACIT-F subscale of =< 34 on a 0 to 52 scale (in which 52 = no fatigue and 0 = worst possible fatigue)
CRP must be >= 3 mg/l in the absence of any other more likely cause of increased CRP like an infection or an autoimmune disorder
No evidence of moderate to severe depression as determined by a HADS depression score of =< 13
Patients on drugs that may prolong the PR or QRS interval durations, such as any of the class I/sodium (Na+) channel blocking antiarrhythmic medications should be avoided (e.g. flecainide, procainamide, propafenone, quinidine)
Patients currently on investigational therapies will be evaluated by the PI on a case by case basis and study participation approval will be obtained from the treating oncologist
Phase II: Not adherent to sun protection recommendations (i.e., mean score < 4 [which corresponds to “often”] on a 5-point scale [from 1 = “never” to 5 = “always”] that assesses the frequency of engaging in four sun protection behaviors)
Women who have a smart phone
The presence of more than mild valvular stenosis or regurgitation, prosthetic valves or pacemaker on their baseline echocardiogram
Poor image quality on baseline echocardiogram or anatomic limitations that preclude the acquisition of good quality images such as recent mastectomy or surgery
Patients who do not have a smart phone onto which the Under Armour application can be downloaded
Patients who are unwilling to wear the Under Armour (UA) health band
Rhythms other than sinus rhythm
Patients unwilling to come to the Johns Hopkins campus to have the required testing performed
Own a smart-phone (Android or i-Phone operating system [iOS])
Capable of downloading and running the study application (app)
Patients with severe cognitively impairments or who appear too weak, emotionally distraught, agitated or ill to participate, as judged by either the research study staff or an oncology provider, will be excluded
Patients who are currently actively tracking their steps using wearable technology or smartphone apps will also be excluded
PATIENTS: Delirium as per Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-V) criteria
FAMILY CAREGIVERS: At the patient’s bedside at least 4 h/day
Planning on remaining in New York City (NYC) for at least 7 months
Licensed taxi driver for at least three months
Currently owns a cell phone, uses text messaging services and is willing to accept text messages for this study
Part-time driver (fewer than 5 shifts/week, totaling less than 35 hours per week)
Must have refractory CINV defined as nausea and/or vomiting that occurs after the first cycle of cancer targeted therapy despite guideline-based prophylaxis and after first-line rescue medication with either a dopamine receptor antagonist, steroid, and/or benzodiazepine
PATIENTS: Willing to be seen at least monthly.
CLINICIANS: Oncology nurses and oncologists practicing at participating clinics.
Have reliable transportation to the testing facilities
Have had a distal, anterograde fasciocutaneous flap
All smokers and tobacco users will be included in this study
Unable to provide meaningful consent (i.e., impairment such that descriptions of the research are not clearly understood)
Presence of a health problem that precludes safe participation in the intervention
Re-initiating ADT after being on holiday for longer than their ADT dosage (e.g. If the man’s dosage is every six months and he has been off ADT for more than six he is eligible)
Able to travel to University of Kansas Medical Center (KUMC) for data collection
Not able to travel to KUMC for data collection
Individuals who are already meeting four or more of the six target dietary behaviors: >= 5 servings/day of vegetables, >= 3 servings/day of whole grains, >= 2 servings/week of dark meat fish, no processed meat, no sweetened beverages, and =< 1 alcoholic drink/day (d) for women and =< 2 alcoholic drinks/d for men
Autologous transplant recipients with multiple myeloma or lymphoma (both Hodgkin’s and non-Hodgkin’s types) will be eligible to participate in the study; those with other disease types will be excluded
Documented consent to participation to include the following study specific procedures:\r\n* Be able to provide up to six serial stool collections at home and deliver to FedEx location that day as per standard operating procedure\r\n* Have three 10-ml blood samples taken during a routine clinic visit\r\n* To not take probiotic supplements except as oriented\r\n* If randomized to the probiotic-supplemented group (the yogurt-based supplement Activia), be willing to comply with daily intake and record this intake as a component of a dietary log; the patient will be asked not to take any yogurt or yogurt-containing foods beyond this\r\n* If randomized to the probiotic-restricted group, agree not to consume yogurt or yogurt-containing foods\r\n* Maintain a dietary log and stool frequency log
Patients with a known intolerance to lactose or other constituents of Activia
Other factors that at the discretion of the investigators would adversely affect study participation
HSCT CGs: Inability to complete role responsibilities 24 hours per day for at least 50% of time (>= 50 days)
Must have two breasts
Must not have broken or irritated skin (as determined by the study nurses or delegated research staff)
Active yoga practice < 3 months
Be open to biomarker feedback
During the first in-person session (phase 1), a smoker must have elevated carbon monoxide (CO) to confirm final eligibility (CO >= 10 ppm)
Approved to be contacted by the treating oncologist/nurse practitioner
Have impaired quality of life (report a score of 5 or less on question 30 of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ C30] “How would you rate your overall quality of life during the past week?” [Answers range from 1 – very poor to 7 – excellent]).
Will also include, as a control, sickle cell patients being admitted for an elective procedure and post-operative surgery patients admitted after elective procedures
Patients must be able to understand and operate the mobile device independently; therefore we will exclude those the provider team considers unable to do so
Oncology Clinician: Current Massachusetts General Hospital (MGH) Cancer Center oncology clinician (board-certified physicians or mid-level practitioners)
Geriatrics Clinician: Current MGH Geriatric Medicine clinician (board-certified physicians or mid-level practitioners)
No medical problems for geriatric clinician to address (e.g. comorbidities, polypharmacy, etc.)
Able and willing to attend in-person PCO workshop at a location convenient to them
Patients who report that they are unable to complete basic functional (e.g., driving, walking) and self-care (e.g., bathing, dressing) activities because of their likely inability to attend the required in-person intervention session
All patients must have a thoracic epidural placed pre-operatively for perioperative analgesia; epidural will be loaded with 2 mg of duramorph after induction of anesthesia and will be started at a rate of 6 ml/hr upon the conclusion of the surgery; a solution of 0.1 % bupivacaine with 2 mcg/ml epinephrine will be used for analgesia; epidural rate will be adjusted for optimal coverage and stable hemodynamics
Subjects must have a Single Item Screening Scale for Fatigue score of >= 4 (out of 10 points, 0 being no fatigue and 10 being severe, incapacitating fatigue) to be eligible for the trial
No patients will be enrolled from vulnerable populations, including neonates, children, prisoners, or institutionalized individuals
Subjects receiving antidepressants, mood stabilizers, antipsychotic medications or benzodiazepines or drugs known to affect the immune system (e.g. glucocorticoids, methotrexate) will also be excluded or at the PI’s discretion
EXCLUSION - STUDY 1: Lower extremity major amputation
Ability to provide informed consent
Ability to provide a written physician's clearance
Patients must be new to the Survivorship Clinic (within 12 months of first visit).
Those who plan on relocating outside the greater Pittsburgh area in the next 3 months of intervention.
Dysphagia or requirement for artificial feeding
The subject has a surgical indication for pancreatectomy (pancreaticoduodenectomy, distal pancreatectomy, total pancreatectomy)
The subject is not willing to consent to EIPL-S lavage vs. EIPL-D lavage vs. standard
Significant insomnia as evidenced by an Insomnia Severity Index score >= 12
Employment that involves irregular sleep patterns, such as shift-work or frequent long-distance travel that involves adjusting to different time zones, or employment in a position that could impact public safety (such as operating heavy machinery)
Reports a fall within the past 1 year OR self-reports that they are concerned about falling
Patient has taken the anti-emetic agents within the last 48 hours prior to the start of treatment with study drug: (1) 5-hydroxytryptamine (HT)3 antagonists (ondansetron, granisetron, dolasetron, tropisetron, etc.); palonosetron is not permitted within 7 days prior to administration of investigational product; (2) phenothiazines (prochlorperazine, fluphenazine, perphenazine, thiethylperazine, chlorpromazine, etc.); (3) benzamides (metoclopramide, alizapride, etc.); (4) domperidone; (5) cannabinoids; (6) neurokinin (NK)1 antagonist (aprepitant); (7) benzodiazepines (lorazepam, alprazolam, etc); (8) herbal medications or preparations in doses designed to ameliorate nausea or emesis
Able to bite upper lip via Upper Lip Bite Test (ULBT)
Liquid only diet < 2 hrs and/or solids < 8 hrs
Unable to bite upper lip via Upper Lip Bite Test (ULBT)
Choledochoenteric anastomosis; transpapillary biliary stent, or sphincterotomy of duodenal papilla
Contraindications to arteriography and selective visceral catheterization:\r\n* Severe allergy or intolerance to contrast media, narcotics, sedatives, or atropine\r\n* Bleeding diathesis not correctable by usual forms of therapy\r\n* Severe peripheral vascular disease precluding catheterization
Receiving elotuzumab and/or other study drugs at the time of signature of informed consent
As per medical record, =< 9 months post-RP
As per medical record, moderate erectile functioning pre-surgery (i.e., 15 or greater on the International Index of Erectile Function [IIEF] Erectile Function Domain [EFD] score, or graded their erections as a 1 or 2 on the standard 5 point Urology Erectile Function scale, or have a score of 6 or greater on the 1-10 pre-surgery erectile function scale on the SMRP assessment or have a total score of 15 or greater on items 2-7 on the Prostate Quality of Life Survey: Sexual Domain)
As per self report or as per medical record starting penile injections as part of the erectile rehabilitation program at MSKCC
Both cavernous nerves fully resected as per surgery report (nerve sparing score of 8 in MSKCC surgeon note), or documented in the progress note that the nerves were fully resected
As per self report, specific injection phobia
Sedentary lifestyle, as engaging in less than 100 minutes structured aerobic walking, cycling or swimming per week
Concurrent diagnosis of organic brain syndrome, dementia, mental retardation, or significant sensory deficit
PHASE 1: PROVIDER ELIGIBILITY: Health professional who works with childhood cancer survivors ages 18 to 25
PHASE 2: PEER MENTOR ELIGIBILITY: Self-reported primary responsibility for care and “complete readiness” using the Readiness for Transition Questionnaire
PHASE 3B: PEER MENTOR ELIGIBILITY: Self-reported primary responsibility for care and “complete readiness” using the Readiness for Transition Questionnaire
As per self-report, is a heavy drinker (regularly having more than 14 alcoholic beverages per week for men, 7 for women)
As per self-report, engaging in night shift work
AYA Inclusion Criteria:\n\n          -  Ever diagnosed with cancer;\n\n          -  Knows his or her cancer status;\n\n          -  Ages of 14 up to 20 years;\n\n          -  Ability to speak English;\n\n          -  Consent from the legal guardian for adolescents aged 14-17;\n\n          -  Consent from a surrogate for adolescents aged 18-20;\n\n          -  Assent from adolescent aged 14-17;\n\n          -  Consent from adolescent aged 18-20;\n\n        Inclusion Criteria for Legal Guardians of Adolescents Age 14-17:\n\n          -  Legal guardian of assenting adolescent participant;\n\n          -  Knows cancer status of adolescent;\n\n          -  Adolescent willingness to discuss problems related to cancer with them;\n\n          -  Age 18 or older;\n\n          -  Ability to speak English;\n\n          -  Consent to participate; Consent for his/her adolescent to participate;\n\n        Inclusion Criteria for Surrogates of AYAs Age 18-20:\n\n          -  Selected by adolescent aged 18 to 20;\n\n          -  Knows cancer status of adolescent;\n\n          -  Age 18 or older;\n\n          -  Ability to speak English;\n\n          -  Willingness to discuss problems related to cancer and EOL;\n\n          -  Consent to participate;\n\n        Exclusion Criteria - for AYA or surrogate decision-maker:\n\n        Developmental delay; foster care; active homicidality or suicidality, depression in the\n        severe range
Non-smokers
Consumption of dietary supplements or medications such as steroids that could affect metabolism
Diet restrictions including vegetarianism, veganism, soy-free diet
Have Wi-Fi connection
Sorror co-morbidity index > 4
HCP: HCP of breast cancer patients/HCP designated by a YBCS study participant: oncologists and their advanced nurse practitioners; and primary care providers in family medicine, internal medicine and gynecology
To be randomized, participants must have the presence of at least 1 reproductive health issue (e.g., birth control practices, fertility concerns, hot flashes, or sexual dysfunction/vaginal discomfort) and 70% adherence on reporting daily hot flashes through text messages during the 1-week run in period
Patients with Mini-Mental State Examination (MMSE) < 24 will be ineligible for participation in the therapeutic trial
Taking a third-generation AI (e.g., anastrozole [Arimidex], letrozole [Femara], or exemestane [Aromasin]) for at least 3 months with sufficient time left in their AI prescription to complete all study assessments (e.g., at least one year left on AIs)
Inflammatory, metabolic or neuropathic arthropathies at the time of recruitment; this includes international classification of diseases (ICD) 10 codes M05-M14
Fibromyalgia (ICD 10 code M79.7)
The child does not have learning challenges
Incarceration
Scheduled for major pancreatectomy (i.e., pancreaticoduodenectomy, total pancreatectomy, or a distal pancreatectomy)
Experiences shortness of breath, chest discomfort, or palpitations when performing activities of daily living
Ureteral stent in place at study registration
Registration >= 3 days after placement of a new stent or >= 1 days after a stent exchange
Active cholecystitis
Taking any of the following drugs at the time of study participation: epidermal growth factor receptor inhibitor, topoisomerase 1 inhibitor (camptothecin, irinotecan); buspirone, benzodiazepines, zolpidem, calcium channel blockers (such as felodipine, nifedipine, verapamil); digoxin or quinidine; codeine or fentanyl; phenytoin, propranolol, rifampin, or theophylline
No phone
PATIENTS AND PARTNERS: Not oriented to time, place, or person as deemed by the clinical team
PATIENTS AND PARTNERS: Regular (self-defined) participation in psychotherapy or a formal cancer support group
T?cell prolymphocytic leukemia (PLL) in partial remission (PR) or better prior to transplantation; must also have =< 20% of bone marrow cellularity involved by PLL (to lower risk of graft rejection)
Contraindication to epidural catheter placement including bleeding diathesis (essential thrombocythemia, idiopathic thrombocytopenic purpura, von Willebrand disease, and hemophilia A or B), neurological dysfunction (multiple sclerosis, subacute myelo-opticoneuropathy or preexisting lower limb neurological deficit), prior extensive spinal surgery or major spinal deformity, pre-operative use of anti-coagulant with planned use of therapeutic dose of anti-coagulant in post-operatively, documented pre-operative coagulopathy (international normalized ratio [INR] greater than 1.3 not on Coumadin or partial thromboplastin time [PTT] greater than 42), platelets less than 100,000/uL, or evidence of infection at potential epidural site
Experiencing 2 or more of the following symptoms felt to be associated (per the patient) with gynecologic cancer or previous gynecologic cancer treatment: anxiety (worry or feeling stressed), cognitive impairment (difficulty concentrating, focusing, memory loss), depression, existential/spiritual distress (hopelessness, lack of meaning in life, lack of peace), fatigue, pain, and sexual dysfunction; these symptoms may be new or worsened since cancer diagnosis; both symptoms from this list must have been present one week prior to eligibility assessment
Practicing mindfulness meditation for an average of more than 1 hour/week or have taken mindfulness training in the past
Lives within a 45 minute drive of greater Memphis area ATC Fitness Center
Contra-indications to resistance training or protein supplementation (e.g. renal) (physicians will verify if they can participate)
Normal cognition
No evidence of significant anxiety or depression as determined by a total HADS scores of < 21
Prior non-tolerance of gabapentin
Upper extremity deformity contralateral to the site of disease that could interfere with accurate point location or alter the energy pathway as defined by traditional acupuncture theory
Able/willing to have an online interaction with a Pillars4Life group weekly for nine weeks
Sedentary lifestyle, as engaging in less than 100 minutes structured aerobic walking, cycling or swimming per week
Concurrent diagnosis of organic brain syndrome, dementia, mental retardation, or significant sensory deficit
Clinical evidence of left heart failure as the main etiology for respiratory compromise
Shock (need for vasopressor therapy or mean arterial pressure [MAP] < 60 despite fluid administration)
pH < 7.30 or partial pressure of carbon dioxide (pCO2) > 50 (if available)
Glasgow Coma Scale (GCS) < 8 or inadequate airway protective reflexes
Undrained pneumothorax/pneumomediastinum
Copious secretions (> 20 cc/hr sputum production or > 100 cc's hemoptysis/24 hrs)
ALS PATIENTS: Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) with < or equal to 2 point decline in last month
TECHNOLOGY REQUIREMENT: Patients will need to own a smart phone that can interface with the Jawbone Up 24
Presence of active malabsorption disorder (e.g., flare episodes documented within the preceding 3 months, presence of symptoms requiring daily medications for control) or history of extensive small bowel resection
Phase 1: Signed consent forms and completed surveys that will be returned to the study team by mail
Patients with a planned exploration with biopsies (no organs removed) will be excluded from the study
Anemia (defined as having a hemoglobin level less than 11.7 g/dL for white women, following the Ohio State University (OSU) hospital’s criteria, and 11.5 for African American women, based on data from Beutler and Waalen)
Individuals who routinely take fish oil, krill oil, or flaxseed (oil, pills, or powder) or consume more than two portions of oily fish per week
Medication exclusions will include steroids as well as statins and other medications with anti-inflammatory actions
Antidepressant users who have been medicated for at least three months will not be excluded
CIPN that may be associated with previous treatment with a vinca alkaloid (e.g. vincristine, vinblastine), or current treatment with a vinca alkaloid
Patients who have > 50% vertebral body collapse
Patients whose physician-approved radiation treatment plan indicates a maximum prescription dose of less than 45 Gy
Patients must be diagnosed with a primary glioma and have refractory partial onset seizure activity (defined as 3 or more seizures in a 28-day period) on non-enzyme inducing anti-epileptic regimen that can include, but not limited to the following: levetiracetam (Keppra) or Keppra XR, lamotrigine (Lamictal) or Lamictal XR, gabapentin (Neurontin), tiagabine (Gabitril), topiramate (Topamax), valproic acid (Depakene)/valproate (Depacon), zonisamide (Zonegran), lacosamide (Vimpat), and clonazepam (Klonopin)
Previous history of suicidal ideation, homicidal ideation, depression leading to hospitalization or mood disturbance leading to hospitalization
Patients will have to present on one of the three days per week that geriatric assessments are available, and be willing to be seen for geriatric co-management on one of the two geriatrician clinic days
Acute myocarditis, pericarditis, or endocarditis in the last week
Suspected dissecting aneurysm
Able to walk without an assistive device
Open, hybrid, robotic, laparoscopic, or laparoscopic-assisted procedure exceeding 2 hours
Receiving a G-CSF for one of the following indications:\r\n* Prevention/treatment of neutropenia along with treatment for leukemia or lymphoma\r\n* Mobilization of hematopoietic progenitor cells\r\n* Neutropenia prevention following autologous hematopoietic cell transplant
There are no exceptions to exclusion; the Data and Safety Monitoring Committee (DSMC) will not approve exceptions
Receiving one of the following drugs and cannot be discontinued at least 24 hours before starting therapy, including: pimozide, quinidine, astemizole, ergot alkaloids
Receiving or anticipated need for methadone as co-administration with voriconazole potentially increases methadone exposure
Self-identify as Latina
First craniotomy
Patients must have had a transrectal ultrasound (TRUS)/endoscopic ultrasound (TEUS) staging within two months prior to treatment start
Report sleep disturbance of 8 or greater on the Insomnia Severity Index (ISI), and report insomnia that began or got worse with diagnosis of cancer or treatment with chemotherapy
Patients must complete the Physical Activity Readiness Questionnaire with “No” answers to all questions; if patient responds with any YES answers, OR IS OVER AGE 69, approval must be obtained from the patient’s primary care provider (PCP) or treating medical oncologist to participate in the study
Able to fast for 12 hours for blood work and basal metabolic rate (BMR) measurement
SUBJECT: Have parent-reported or documented difficulties in attention, processing speed, memory, or learning as assessed by the screening questions (a score of at least 3 on any one of the 4 questions or the participant having >= 1/2 standard deviation [SD] decline in test scores, scores < 85, or special education services or accommodations).
SUBJECT: Significant medical problems, such as severe uncontrolled illnesses, or physical impairments that prohibit the child from exercising at moderate to vigorous levels based on the clinical judgment of the examining physician or nurse practitioner.
Loss of a child at least 6 months ago who had been diagnosed with cancer as reported in the child's medical record or by parent report
Loss of a child 39 years old or younger as reported in the child's medical record or by parent report
Residing in New York, New Jersey, Connecticut, or Pennsylvania for part 1 step 1 (P1S1); residing in New York for P1S2; and residing in New York or New Jersey or ability to complete sessions in New York or New Jersey for part 2, as reported in the child's medical record or by parent report
SUPPORT PROVIDER: Must reside in New York or New Jersey or ability to complete sessions in New York or New Jersey
Significant psychiatric disturbance sufficient, in the investigator's judgment, to preclude completion of the assessment measures, interview or informed consent
SUPPORT PROVIDER: Significant psychiatric disturbance sufficient, in the investigator's judgment, to preclude completion of the assessment measures, interview or informed consent
Self-identify in one of the following primary practice roles--case managers, clinical nurse specialists, nurse practitioners, managers/coordinators, nurse navigators, patient educators, and staff nurses
Available email address
Lack of email address
Receiving erythropoietin stimulating agents prior to admission
Patients with extreme mobility issues (e.g. unable to get in and out of a chair unassisted)
Radiation therapy, cytotoxic chemotherapy, and combined modality (both radiation and chemotherapy) used to treat other cancers or medical conditions and administered within 6 months prior to study enrollment; use of hydroxyurea or emergent leukapheresis (for cytoreduction of highly elevated white blood cell counts) is permissible; those AML patients who initially receive treatment with all-trans retinoic acid (ATRA) for presumptive diagnosis of APL but if APL is ruled out in final pathology will be eligible for the study
Prior history of treatment with recombinant thrombopoietin (TPO) or TPO-receptor (R) agonists
No appropriate caregivers identified
Willingness to be randomized to one of the study arms
Mental impairment leading to inability to cooperate
Patients of east Asian ancestry (Chinese, Japanese, or Korean origin)
Dietary eligibility requirements from a 7-day food record fruit and vegetable (FV) intake less than < 5.5 servings/day, not including potatoes and iceberg lettuce
Be chronically fatigued as defined by having a >= 4 on the Brief Fatigue Inventory
Cannot supplement with fish oil and other omega-3-fatty acids
Planning on starting or stopping any chronic supplements or medications within six weeks prior to or throughout the study period
Inability to conceive after 6 months of unprotected intercourse with male
Written clearance for the procedure from the patient’s oncologist
Experiencing disability as indicated by a score of >= 3 on the Vulnerable Elder survey
Has a Hamilton Rating Scale for Depression (HAM-D) 24-item score of more than 20
Use of concomitant medications that substantially increase seizure risk; such drugs could include neuroleptics (ex. haloperidol, droperidol), clozapine, tricyclic antidepressants (ex. amoxapine, clomipramine), bupropion (particularly the immediate release -IR- formulation) donepezil, psychostimulants (ex. methylphenidate), theophylline and/or other drugs that reduce the seizure threshold; for individuals on any of these medicines, a study clinician will evaluate the drugs and doses to determine the risks and benefits; these will then be discussed with the individual's Primary Care Physician to determine if the individual should be excluded from the study
Dysfunctions of lungs, liver, gastrointestinal tract, hematopoietic and central nervous systems will not affect eligibility for this protocol
Patients must meet the following clinical criteria to receive CMVpp65-CTL infusions\r\n* Stable blood pressure and circulation, not requiring pressor support\r\n* Evidence of adequate cardiac function as demonstrated by electrocardiogram (EKG) and/or echocardiography\r\n* A life expectancy of at least 3 weeks, even if requiring artificial ventilation\r\n* There are no age restrictions
Patients who are moribund
Patients having their LPs done by students will be excluded
No prior nitrosourea (e.g. lomustine, carmustine)
Received any drug with potential anti-emetic effect within 24 hours prior to the start of study-designated chemotherapeutic agent: 5-hydroxytryptamine type 3 (HT3) receptor or substance P/neurokinin 1(NK1) receptor antagonists; dopamine receptor antagonists (metoclopramide); phenothiazine anti-emetics (prochlorperazine, thiethylperazine and perphenazine); diphenhydramine, scopolamine, chlorpheniramine maleate, trimethobenzamide; haloperidol, droperidol, tetrahydrocannabinol, or nabilone
Ongoing vomiting from any organic etiology
Case review by the study chair, or designate, as a case where treatment should be tried
Patients with implantable drug delivery systems, e.g. Medtronic Synchromed
Willing to be randomized to one of the study arms
Mental impairment leading to inability to cooperate
Have a Distress Thermometer score of 4 or greater or a score of >= 6 on the Depression or Anxiety subscale of the Hospital Anxiety and Depression Scale (HADS)
Actively participating in protocol 07-094 or 11-021
Asplenia
Patients must have a smart phone, be able to have their oral oncolytic filled at the University of Michigan Comprehensive Cancer Center pharmacy and be newly prescribed capecitabine (Xeloda)
Able and willing to document symptoms and treatment details as often as needed, not to exceed daily notes
Able and willing to have photographs of the affected area taken regularly
Underlying cervical segmentation or other cervical spinal anomaly that results in differential nerve root pressures
Location of pain is outside the distribution of the ICBN, can be directly attributable to trauma to a nerve other than the ICBN, or is consistent with trauma during breast surgery to a nerve other than the ICNB (e.g. medial and lateral pectoral nerve; long thoracic nerve; thoracodorsal nerve; other intercostal nerves)
Immunosuppression
Patients who underwent a linear closure on the face at University Hospitals (UH) Mohs clinic
PATIENTS ONLY: Regularly (self-defined) participated in a yoga practice in the year prior to diagnosis
Presence of fatigue on a numerical scale during the last 24 hours of more or equal to 4 on a 0 to 10 scale on which 0 equals no fatigue and 10 worst possible fatigue
Presence of relatively intact cognition defined by normal Mini Mental State Questionnaire according to age and education level; a score of 24 or above is usually considered normal
Currently on methylphenidate or has been on methylphenidate within the last 10 days
Patients with glaucoma
CAGE questionnaire score is 2 or above on a 0 to 4 scale
Agree to install and share data from the FitBit Flex smart phone app with the investigators
Lactose intolerance or intolerance to milk products
Subjects are currently receiving ADT for prostate cancer and will continue on ADT for at least 13 weeks after enrollment. Patient may have been started on ADT at any past time point because patients experience hot flashes throughout ADT treatment.
Patients who are classified as being opioid tolerant by receiving a baseline MEDD of >= 60 mg
Patients receiving methadone or transdermal fentanyl due to reasons such as long and variable half-life and transdermal rather than oral route for delivery of opioids
Have a 5-year survival rate of 50% or greater as deemed by their oncologist, surgeon, or other relevant attending physician (suggesting a reasonable rate of cure or prolonged medical survival with state-of-the-art medical care).
Among patients treated in the urban centers, we will specifically target patients who live more than 40 miles away from the clinic as they are more likely to experience problems with access to care.
Admitted to the hospital
Patients who are admitted for observation for < 48 hours will be excluded from the study, as one day would be difficult to provide the necessary information
Patients receiving myeloablation (MA) or reduced intensity conditioning (RIC) are allowed
Patients must have had neuropathic symptoms for a minimum of 3 months.
Live within a 50 mile radius of MD Anderson’s main campus.
Men or women with a history of CRF as defined by a score >= 4 on the numeric analogue scale (0 – 10) (Eligibility Question Fatigue Scale)
Currently using any other pharmacologic agent to specifically treat fatigue including psychostimulants, antidepressants, etc., although antidepressants used to treat items other than fatigue (such as hot flashes) are allowed if the patient has been on a stable dose for >= 30 days prior to registration and plans to continue for >= 30 days after registration; erythropoietin agents to treat anemia are allowed
Has gastrointestinal symptoms with severity score of =< 60 out of 100 visual analog scale for irritable bowel syndrome (VAS-IBS) in at least 2 out of 7 items measured
Able to eat by mouth
Estimated length of hospital stay is 10 days or more
Patients who need intraoperative evoked potential monitoring which precludes the scalp block
Patients with known cranial defects
Known IgG4-mediated cholangiopathy.
Surgically altered luminal anatomy other than prior Billroth reconstruction.
All gynecologic laparoscopic/robotic surgeries EXCEPT diagnostic laparoscopies
Patients planning to undergo hand-assisted laparoscopy
FCGs: Find conversations around religion or spirituality emotionally upsetting
No other agents have any possible potentiation or decreased activity related to olfactory training and thus there is no need for any exclusion criteria related to this
CAREGIVERS
Patients will be excluded if they have any of the following medical conditions that would prohibit the safe implementation of self-care of LEF: recurrent or metastatic cancer; any other active cancer; acute infection; congestive heart failure; renal failure; cardiac or pulmonary edema; sensitive carotid sinus; severe carotid blockage; and uncontrolled hypertension
Patient self-reported ESAS psychological scale score (sum of anxiety and depression scores) between 4 and 11 (and/or) individual anxiety or depression score between 4 and 7 on a 0 to 10 numeric scale, where 10 is the worst possible
Subnormal intellectual potential (intelligence quotient [IQ] below 80)
Current suicide risk or significant intentional self-harm in the last six months sufficient to preclude treatment on an outpatient basis
Follow-up either here at University of Southern California (USC) or centers that are available to transfer the requested clinical and radiological data
Allergy or adverse reaction to ropivacaine (ropivacaine hydrochloride) or any amide type of local anesthesia
Admitted to Lunder at Massachusetts General Hospital
Admitted electively
Study materials will be available in English or Spanish; if families would like to be part of the trial, but do not speak either of these two languages, arrangements can be made to include them using University of California at San Francisco (UCSF)'s translation services
Receiving treatment at UCSF Benioff Children’s Hospital San Francisco or Oakland
Willingness to be randomized
Self-reported inability to walk 2 blocks (at any pace)
Participants with evidence of diarrhea as defined by three or more loose or liquid stools per day or loose watery stool (greater volume of stool), that occurs more frequently than usual and lasting for more than three days prior to admission, history of inflammatory bowel disease, irritable bowel syndrome, colectomy or bariatric surgery, celiac disease
Patients who are able to read, understand and write English; if FLIE which has been translated into other languages, and validated, becomes available, then patients speaking these languages can be enrolled if translation of the symptom diary can be arranged dependent on availability of suitable translators
Patients who are known to be hypersensitive to aprepitant, granisetron or any of the components of the patch or to dexamethasone
Patients who are pregnant or nursing; to date, no fetal studies in animals or humans have been performed; the possibility of harm to a fetus is likely
Reside in Southern California
BCS treated at Kaiser, an health maintenance organization (HMO) provider, will be excluded since their SCP implementation project is underway
Neurological examination within 1 week prior to registration to rule out rapid neurologic decline; patients with mild to moderate neurological signs are eligible; these neurological signs include radiculopathy, dermatomal sensory change, and muscle strength of involved extremity 4/5 (lower extremity for ambulation or upper extremity for raising arms and/or arm function)
> 50% loss of vertebral body height
Patients with rapid neurologic decline
Bony retropulsion causing neurologic abnormality
Patients who are diabetic
Caregiver of a patient who will be hospitalized to undergo first-time autologous (self) or allogeneic (alternative donor) BMT in the University of Michigan Mott Children’s Hospital BMT Unit
Have a permanent ostomy or anastomosis
Patients discharged to another inpatient facility (hospice, skilled nursing facility, long term acute care hospital [LTACH], or acute rehab) or patients discharged home with hospice will be excluded
Any patients that are transferred to another unit prior to discharge will be excluded
Child: existing history of severe cognitive impairment (intelligence quotient [IQ] =< 70) as reported by the parents or the child's City of Hope medical records, or by the child's performance score on the Wechsler Intelligence Scale for Children (WISC) Working Memory and Processing Speed index measures administered in this study
Report sitting for >= 8 accumulated waking hours on a typical day
Are willing to attempt reduction of sitting time
Are able to move from sitting to standing without difficulty and to walk 1 block
Alemtuzumab or any equivalent in vivo T-cell depleting agent
Minorities will be recruited; no exclusion to this study will be based on race
Substantial dementia (based on Folstein Mini Mental State Examination < 24 out of 30)
Participants must not be actively receiving physical therapy in a relevant area (e.g. leg strengthening, balance and gait training), at time of enrollment, or participating in intensive (30 min per day) aerobic program three times per week
Hemiplegia or lower limb amputation
Significant orthopedic or muscluloskeletal condition that does not allow weight bearing
Unable to maintain safe stance and walk, either with or without an assistive device
BC patients at Moffitt Cancer Center (MCC)
Received a referral letter for GC from their MCC physician
Of Ashkenazi Jewish descent
Planned less than two week hospitalization
Has an outpatient appointment within University of North Carolina (UNC) Chapel Hill Lineberger Comprehensive Cancer Center
Has at least one functional deficit as defined by GA screen
Understands study design, risks, and benefits and have signed informed consent
Preferentially, patients should have active refractory-cGvHD; any degree of severity (as per NIH criteria) and/or pattern of organ involvement may be considered; (that said, patients with more severe and/or extensive chronic GvHD are expected to be the usual candidates for LD-TLI protocol therapy)
Ideally, patients' refractory cGvHD should be controlled to a degree that would potentially permit no additional requirement for systemic IST before and following TLI =< d -15 and >= d +45, respectively (NOTE: Relatively minor dose modifications of ongoing medications and topical therapies will be exempt)
The ability to administer protocol doses of TLI (i.e., 100, 150, 200, 250 or 300 cGy) without exceeding cumulative doses of radiation must be established; for patients with prior radiotherapy exposure, this determination will be made by Dr. Greven (or her designee) using published guidelines for excessive organ exposure; (in rare cases, this may apply to retreatment; if so, all of eligibility requirements must be met again)
NOTE: If such hematologic abnormalities are present and deemed due to the process of cGvHD, these requirements may be waived with the approval of the principal investigator (PI)
Patients will be excluded if they are hospitalized
Subjects with cold agglutinin disease or cold urticaria
Living within a 50 mile radius of the City of Hope
Patients undergoing allogeneic transplant must have, or be scheduled to have, an external tunneled central venous catheter (CVC) (Broviacs, Hickmans, tunneled percutaneously inserted central catheter [PICCs], etc.) and/or non-tunneled percutaneously inserted central catheter (PICC) that is expected to remain in place for an additional >= 3 months
Neuropsychological tests will be performed by a trained examiner
Patients may not take memantine
Communication difficulties to include\r\n* Uncorrected or uncompensated hearing and/or vision impairment\r\n* Uncorrected or uncompensated speech defects
Self-identify as Hispanic or Latina
PEER NAVIGATORS:
Owns an operational vehicle
Inability to perform the testing procedure (for example, because of aphasia, motor deficits affecting the dominant hand, or intelligence quotient [IQ] < 70)
Artificial joints in the upper quadrants
Medication(s) known to affect body fluid balance
Women who report themselves to be of Latino or Hispanic ethnic background (defined as Spanish, Mexican, Central or South American, Cuban, Puerto Rican, Dominican, or other Hispanic origin)
Women who are under- or uninsured and come from low-income communities
Evidence of recent (less than 2 weeks) hemorrhage on postoperative MRI of the brain; however, patients with clinically asymptomatic presence of hemosiderin, resolving hemorrhagic changes related to surgery, and presence of punctate hemorrhage in the tumour are permitted entry into the study
Inadequately controlled hypertension (defined as the normal published range for age and height)
Have at least one geriatric assessment domain meet the cut-off score for impairment other than polypharmacy
Planned participation in the Gynecologic Enhanced Recovery Pathway
Consents to being part of a randomized, single-blinded study
Patients on long-acting opioid medications, or scheduled (four or more times a day for seven or more days) short-acting opioid medications within the last 30 days
Requirement for significantly modified diet (liquids and/or solids) due to compromised oral/pharyngeal function at baseline
Active infectious disease excluding oral candidiasis
Requirement for concurrent treatment with nitrates or other drugs that may, in the judgment of the treating investigator, create a risk for a precipitous decrease in blood pressure
Radiographic evidence of hydrocephalus or other architectural distortion of the ventricular system, including placement of external ventricular drain or ventriculoperitoneal shunt
Inclusion Criteria: Subjects will be drawn from the pool of all parents who are primary\n        caregivers of children diagnosed with any form of cancer 4-16 weeks prior to contact about\n        the Problem Solving Skills Training intervention and cared for at one of the 4 data\n        collection sites. No attempt will be made to stratify the sample by any particular\n        demographic variables (e.g., age, ethnic background, or type of cancer diagnosed in their\n        child), except that monolingual Spanish-speaking parents will be specifically recruited to\n        provide adequate representation for statistical analysis at Childrens Hospital Los Angeles\n        and UT/MD Anderson Cancer Center. Goal: 20% total enrollment.\n\n        Exclusion Criteria: Parents of children with cancer will be excluded if (1) they do not\n        read or speak English or Spanish; (2) their child is in severe a medical crisis, as\n        determined by the oncologist, or (3) they live a prohibitive distance to complete the\n        intervention (typically, >50 miles from the Center) and do not have access to a telephone\n        for phone intervention sessions. Internet access will be facilitated as part of the e-PSST\n        intervention arm. These exclusionary criteria are identical to our previous work; <10% of\n        eligible mothers have been excluded.
Patients must have aromatase inhibitor (AI)-associated musculoskeletal symptoms that began or increased after starting AI therapy; new musculoskeletal pain must not be due specifically to fracture or traumatic injury
Women who are currently on omega-3 fatty acid supplements with > 500 mg of eicosapentaenoic acid (EPA) + DHA daily or 250 mg of DHA alone and or who have chronically been on more than 1 fish oil capsule per day; there is no exclusion based on fish intake
Individuals who are not willing to stop fish or krill oil supplements during the study; (note that there is no limit to fish intake or omega-3 fatty acid [FA] in food)
Functionally appropriate to participate in the intervention, as assessed by 3 functional assessment items from the European Quality of Life-5 dimension (EQ-5D)
Endorsement of at least one sexual symptom
Currently receiving any type of formal counseling for depressive symptoms (allowing caregivers who receive outside counseling for depressive symptoms could contaminate treatment groups)
Patients who are at elevated risk for CRC, defined as having ever been diagnosed with CRC, a precancerous (adenomatous) polyp, or inflammatory bowel disease
PATIENTS WITH CIN:
PATIENTS WITHOUT CIN:
Patients without CIN will be matched on cancer diagnosis and CTX agents administered (i.e., only a platinum compound, only a taxane, or both) to the patients with CIN but will not have any of the changes in sensation or pain listed above for patients with CIN
Currently practicing mindfulness-based interventions (yoga, meditation, deep breathing)
Require psychotherapy within the last three months
Expect to relocate from Northeast Ohio within 2 months
Wake Forest University student
Have volunteered as a student strategist at Comprehensive Cancer Center of Wake Forest University (CCCWFU); all strategists are required to have gone through Take the Fight (TTF) training prior to their volunteer work
Case review by the study chair, or designate, as a case where treatment should be tried
Existing operational implantable drug delivery systems, e.g. Medtronic Synchromed
Referral to pulmonary or interventional radiology services for large-volume thoracentesis
Study subject has any disease or condition that interferes with safe completion of the study including:\r\n* Coagulopathy, with criteria left at the discretion of the operator\r\n* Hemodynamic instability with systolic blood pressure < 90 mmHg or heart rate > 120 beats/min, unless deemed to be stable with these values by the attending physicians
Referral is for diagnostic thoracentesis only
Inability to assume or maintain a seated position for the procedure
Presence of multiple loculations on bedside pre-procedure ultrasound
Absence of dysphagia
Participants will self-identify racial/ethnic status as African American (black or of African descent), Hispanic (Latino), or Caucasian (white)
Assessed as competent based on responses to mental status screener
Concurrent participation in Lineberger Comprehensive Cancer Center (LCCC)1311 or LCCC1234
Verification of a functioning email address and access to electronic device(s) capable of charging and syncing the FitBit
Willing to wear the FitBit throughout the study period
Pancreaticoduodenectomy
Firm gland texture
Failure to extubate at the conclusion of the case
Operative time > 8 hours
No active gallbladder disease
No active gout
No active diverticulitis
Able to commit to LOFT training 2 times/week for 4 weeks
Individuals with progressive metastatic disease in which the tumor has increased in size, volume and diameter or evidence of new lesions, as noted by medical oncologists, radiologists and surgeons
Vocal fold paralysis
Symptomatic patients with a BFI symptom scale of 2 points or greater
CIPN neuropathy: received neurotoxic chemotherapy in any setting as cancer treatment; including taxanes-such as paclitaxel or docetaxel; platinum-based compounds such as carboplatin or cis-platinum or oxaliplatin; or, vinca alkaloids such as vincristine, vinblastine, or vinorelbine, or proteasome inhibitors such as bortezomib\r\n* NOTE: patients should no longer be receiving the therapy that caused the CIPN, or have recently started a new treatment that may worsen CIPN; patients on a treatment that may cause CIPN for a period of time where CIPN does not appear to be worsening may be allowed at discretion at the principal investigator
Patients with implantable drug delivery systems, e.g. Medtronic SynchroMed
1st episode of CDI
Hypotension or shock
Persistent genitourinary symptoms causing discomfort for more than 2 weeks prior to the visit with the physician
Tried at least 1 prior pharmacological/non-pharmacological treatment for their genitourinary symptoms
Patients with vaginal stenosis
Willingness to abstain from ingestion of yogurt products and/or any product containing probiotics during study drug treatment
Previous bowel resection which, in the opinion of the investigator, would decrease the benefit of the probiotic; patients who have undergone recent bowel surgeries which would not decrease the benefit of the probiotic are eligible provided they are more than 30 days from surgery with no serious complications
Concurrent diagnosis of organic brain syndrome, dementia, mental retardation, or significant sensory deficit
Unstable medical problems (such as unstable heart disease, unstable hypertension, diabetes in poor control, respiratory disease complicated by hypoxia or hypercapnia, infectious illnesses, unstable thyroid dysfunction, currently hospitalized)
History of, or current symptoms of, serious psychiatric disorder requiring antipsychotic medications or hospitalization; mild depression or stable anti-depressants, and anti-seizure medications are acceptable; anti-anxiety medications may be acceptable
For the subset of participants undergoing neuroimaging:\r\n* Medical history or devices which make an MRI unsafe or uncomfortable (e.g., magnetic rods or pins, metal plates or screws, pacemaker)
Patients with extreme mobility issues (e.g., unable to get in and out of a chair unassisted)
Patients who have practiced yoga or taken yoga classes in the year prior to study enrollment or who are currently engaged in a regular mind-body practice
Profess extreme dislike of music.
Wait time is longer than 240 min.
At risk for mucositis OR with stage I mucositis or esophagitis (i.e. radiotherapy to the head, neck, esophagus or lung OR treatment with fluorouracil (5-FU) or other chemotherapeutic agents that are known to cause mucositis or esophagitis) or at risk for xerostomia
Inability to taste or smell due to medication or health condition
They are already receiving PC or hospice services
Prospective study: Physically capable of using a tablet computer (no severe visual, hearing, or hand motor deficits)
Have daily use of an iPhone or iPad that meets the following technical specifications: at least iOS 8; for iPhones, must be iPhone 5 or above
Patients admitted to the acute inpatient rehabilitation unit and those seen in the Physical Medicine and Rehabilitation outpatient clinic
Capable of completing questionnaire in English
Co-morbid delirium, dementia, mental illness, or neurocognitive deficit prohibiting informed consent and/or ability to complete study procedures
Bothersome hot flashes (defined by their occurrence of >= 28 times per week and of sufficient severity to prompt the patient to seek therapeutic intervention)
C-reactive protein (CRP) must be >= 10 mg/l in the absence of any other more likely cause of increased CRP like an infection or an autoimmune disorder
Patients with phaeochromocytoma
Recent history of attending regular QMBE or similar classes (e.g. yoga or tai chi classes i.e. 20 or more classes in the past 6 months)
Patients who are blind are excluded
Functional limitations requiring a walker/scooter/wheelchair for daily activities
Resistance training on > or = 2 days/week accounting for more than 30 minutes of strength training per week
Patients with a history of significant allergy to foods not excluded from the donor diet (excluded foods are tree nuts, peanuts, shellfish, eggs)
Dementia (i.e., 290.XX or 331.XX)
Has a partner or spouse who is >= 21
Autologous transplant recipients with multiple myeloma or lymphoma (both Hodgkin’s and Non-Hodgkin’s types) receiving the most common autologous regimens, melphalan and cyclophosphamide, carmustine, and etoposide (CBV)/carmustine, etoposide, cytarabine, and melphalan (BEAM)
Those receiving reduced intensity regimens (a small proportion of allogeneic transplant recipients at UWCCC)
New onset or worsening of fatigue since starting TKI
Report moderate-severe fatigue in past week (Fatigue Symptom Inventory [FSI] average rating >= 4 of 0-10)
Thienopyridine therapy (clopidogrel, prasugrel, or ticagrelor) that will be continued on study
Mechanical heart valve
Documented hemorrhagic tendencies
Bacterial endocarditis
Cognitively intact, as evidenced by orientation to person, place, and time
African-Americans and non-Hispanic Whites
Inability to understand English as some study instruments have not been validated in other languages
Women who report a change in their body/self-image since diagnosis and wish to improve it; specifically, two screening questions will be used: has your body image or self-image changed in an unwanted way since your cancer diagnosis? (answer must be yes) would you like to be able to do something to improve your body image or self-image? (answer must be yes) answers to both questions must be yes for a woman to be eligible
Latino
A current resident of either King, Snohomish or Pierce counties in Washington State with the intent of remaining a resident for at least 3 months following study enrollment
Individuals who lack the capacity to consent will be excluded from this study
Cut-annoyed-guilty-eye (CAGE) positivity (>= 2/4)
Patients with normal saliva production (no salivary gland changes; no xerostomia)
Patients who are on pilocarpine for ophthalmic or non-ophthalmic indications
Patients who are on regular medications which will induce xerostomia (tricyclic antidepressants, antihistamines with anticholinergic effects)
Men with prostate cancer managed at University of California, San Francisco (UCSF)
Be able to walk unassisted
Patients may or may not report any of symptoms related to lymphedema (i.e. swelling, heaviness, tightness, firmness, numbness, tingling, stiffness, limb fatigue, limb weakness, and impaired limb mobility of shoulder, arm, elbow, wrist, and fingers)
Patients with sinusitis, obstruction of nasal passages, nasopharyngeal cancer, paranasal sinus malignancies, or any conditions in the nasopharyngeal anatomical area that may affect the absorption of fentanyl nasal spray
Has taken oral immediate release opioids within 4 hours prior to arrival
Blindness or severity of visual impairment that precludes one’s ability to view images/text
Patients with known difficult airways
Patients where other lung isolation devices may be warranted (tracheostomy, nasal intubation)
Patients requiring a right sided VDLT or DLT
Patients with a bowel ostomy
Provide consent and permission to review their medical records
Plan to stay in the study area for 3 months
Prior lumpectomy
ONCOLOGIST: Care for oncology patients at the Indiana University (IU) Simon Cancer Center or an affiliated clinic (e.g., Spring Mill Clinic, Eskenazi Health, IU Health North, IU Health West)
ONCOLOGY NURSE: Be a registered nurse or advanced practice nurse who provides care to patients seen by an enrolled oncologist
INTERVENTION PHASE: While on neurotoxic chemotherapy, has developed NCI-CTC grade 2 CIPN
Resident of Oahu, Hawaii (HI)
Anti-inflammatory medications (e.g. statins, cholesterol medication)
Possession of smartphone to have a Fitbit synced to
Long term survivor of ALL
History of executive dysfunction, documented by SJLIFE neurocognitive testing, and defined as having an age-adjusted standard score < 20th percentile on Trail Making Test Part B, Verbal Fluency, or Digit Span Backward
History of self-reported executive dysfunction in daily life, defined as having a standardized score < 20th percentile on Behavior Rating Inventory of Executive Function (BRIEF) Initiate, Shift, or Working Memory domains OR having scored < 20th percentile on the Childhood Cancer Survivor Study Neurocognitive Questionnaire Task Efficiency or Memory domains
Any survivor with full scale intelligence quotient (IQ) < 80
Anatomically intact parotid and submandibular glands
Must be right-handed
Upper or lower extremity deformities (ie, missing limbs or scars that prevent needle insertion at the acupuncture points) that could interfere with accurate acupoint location or alter the energy pathway as defined by traditional acupuncture theory
Report clinically significant anxiety symptoms (i.e., Hospital Anxiety and Depression Scale Questionnaire [HADS]-anxiety subscale >= 8)
Anxiety is principal psychiatric problem
RCT: Participants will come from urban and rural regions of the country
Needle path without transgression of pleural fissure, bleb, or bulla is possible
INDIVIDUAL INTERVIEWS:
Are within traveling distance to Fox Chase Cancer Center (FCCC) and Mount Sinai Medical Center (MSMC)
Are within traveling distance to FCCC, MSMC, Rutgers Cancer Institute of New Jersey, or Temple University Hospital (TUH)
Patients in whom the transnasal endoscope is poorly tolerated or patients in whom transnasal endoscopic laryngoscopy is contraindicated will be excluded
Patients and caregivers who are not oriented to time, place, and person
Patients who have regularly practiced yoga in the year prior to recruitment
Treated at one of the Survivorship Centers of Excellence or their community affiliates
Have BFI =< 3
Planned fractionated external beam radiotherapy to be delivered by opposing, tangential beams to 50.4 Gy in 28 fractions with a planned photon or electron boost of 10 Gy in 5 fractions (for a total of 33 fractions)
Any infection or unhealed wound of the radiotherapy portal areas, or generalized dermatitis
Patients with external biliary drains
Presence of any bladder or urethral anatomic feature that in the opinion of the investigator may prevent the safe placement, indwelling use or removal of TAR-200.
All patients who do not have a documented NF1 mutation must meet the clinical diagnosis of NF1 using the National Institutes of Health (NIH) Consensus Conference criteria; in addition to tibial pseudarthrosis, one or more of the following diagnostic criteria for NF1 must be present:\r\n* Six or more cafe-au-lait spots (>= 0.5cm prepubertal; >= 1.5cm postpubertal)\r\n* Freckling in the axilla or groin\r\n* Optic pathway glioma\r\n* Two or more iris Lisch nodules\r\n* Two or more neurofibromas or one plexiform neurofibroma\r\n* A first-degree relative with NF1
Patients must have tibial pseudarthrosis that has the potential to cause significant morbidity; radiographic findings (anterior-posterior [AP] & lateral leg radiographs) must support the diagnosis of tibial pseudarthrosis with chronic non-union
Tibial fracture without evidence of pseudarthrosis or tibial dysplasia
Tibial dysplasia/bowing without fracture or pseudarthrosis
Visual impairment from any cause
Precocious puberty from any cause
Inadequate neurovascular status in the involved limb that may jeopardize healing
Two or more prior surgeries for tibial pseudarthrosis
Selection of a surgical approach that does not include prescribed surgical intervention, which must include removal of pseudarthrosis tissue, placement of an intramedullary rod using the Williams approach, and autogenous bone graft from the iliac crest distributed at the osteotomy site
Need for postoperative medications that could interfere with bone healing of the implant, such as steroids, (but not including low-dose aspirin or routine perioperative antiinflammatory drugs)
Metastatic disease that involves major airways or blood vessels, or centrally located mediastinal tumor masses of large volume. HCC participants (Arm A and F) with vascular invasion of the portal or hepatic veins may be enrolled
HER2 expression as defined by ISH positive and/or 3+ by immunohistochemistry
Prior chemotherapy treatment, including radio-sensitization in pre- and post-operative settings
A CXR shows hydropneumothorax.
Have poor-risk prognostic factors defined as antecedent hematologic disorder, prior chemotherapy or XRT, abnormal karyotype other than t(8;21), inv16, or t(16;16), any karyotype with FLT3-ITD, or presenting WBC>100K, or
Group 3: Patients known to be KIT wild type.
The surgical cavity is clearly visible on CT images
Peritoneal carcinomatosis index (PCI) >= 10
Anal cancer that cannot be completely excised with a >= 1 mm clear margin from surrounding tissue or where excision to obtain a clear margin would compromise sphincter function or anal canal diameter
Concurrent anal canal or perianal HSIL or condyloma that in the judgment of the clinician cannot be cleared or can only be cleared with undue morbidity to the participant
Baseline AFP ?400 nanograms/milliliter.
Congestive cardiac failure of >Grade 2 severity according to the NYHA defined as symptomatic at less than ordinary levels of activity
Right handed (quantitative EEG [qEEG] database comparison is specific to handedness; by requiring all participants be right handed, we will be consistent across EEG analysis)
Mini-Mental State Examination score of 23 or below
Any extreme mobility issues (e.g. unable to get in or out of a chair unassisted, extremity issues such as neuropathy that limits physical manipulation of objects
PILOT PARTICIPANTS AND HEALTHY CONTROLS ONLY: Any extreme mobility issues (e.g. unable to get in or out of a chair unassisted, extremity issues such as neuropathy that limits physical manipulation of objects)
Receiving cancer care at either Massachusetts General Hospital Cancer Center or community affiliates (North Shore, Emerson, and Massachusetts General Hospital [MGH] West)
Uses smart mobile phone (either iOS [iPhone] or Android device)
Phase 1: Clinician participants must be oncology clinicians (i.e. physicians and nurse practitioners) who maintain at least 25% clinical practice at the MGH Cancer Center or one of its community affiliates at the North Shore, Emerson Hospital and MGH West
Phase 1: For this proposed study, four groups of stakeholders will provide ongoing feedback about the study design, methods, and results; to be eligible as a stakeholder, the participant must be able to represent the interests and perspective of at least one of the following stakeholder groups: 1) oncology patient or family member; 2) oncology physician; 3) cancer practice setting administrator; and 4) health system, community, and society
Active Clostridium difficile infection or on prophylactic or tapering antibiotics for Clostridium difficile infection
Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-F) subscale score >= 10 pre-radiation therapy and decrease in FACIT-F of 10 points or more as compared to prior FACIT
Patients who are currently on stable prescription medications or dietary supplements for CIPN and still symptomatic as defined above will be allowed to participate in the study; related medications are: gabapentin, pregabalin, nortriptyline, amitriptyline, duloxetine, venlafaxine; lidocaine, opioid tramadol and other narcotics; NSAIDs; glutamine, glutathione, vitamin E and vitamin B12
Receiving concurrent chemoradiotherapy/chemobiotherapy to a minimum dose equivalent to 60 Gy in 30 fractions in the adjuvant or definitive setting
Referred to MSK’s Tobacco Cessation Program
Have sufficient sensory acuity (i.e., auditory, visual) and manual dexterity to use a computer game as per judgment of clinician or consenting professional
Immediate reconstruction with tissue expander (Group 2) or permanent implant (Group 1) prior to radiation therapy (RT) performed at MSKCC
Baseline presence of oral ulcers
Patients on warfarin (patients on injectable blood thinners, such as Lovenox, are able to continue those)
Presumed ampullary or duodenal cancer based on preoperative work-up or intraoperative findings
Caregiver has a T score >= 55 (at least one half standard deviation above the population mean) on either the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety or Depression measure or a Distress Thermometer score of 3 or higher
Patients who currently practice yoga or have taken a yoga class regularly within the last 6 months
Surgery will be supervised by one of the gynecologic oncology attendings at Washington University School of Medicine
Mental incapacity
Prior history of hernia repair with mesh, or multiple (> 1) prior hernia repairs, or plan to use mesh for hernia closure in current surgical procedure
Participants who have recently started or changed doses of psychoactive medication which might affect psychological outcome measures in the judgment of the study PI; allowable time frames are medication-specific and will be determined by the study PI
Delirium as per the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria
FAMILY CAREGIVERS:
Patients must have normal baseline self-reported taste perception prior to the development of cancer
Patients with a subjective history of an extreme dry mouth syndrome that prevents them from producing adequate amounts of saliva (approximately 2 mL in 15-20 min)
Patients must have begun postoperative oral intake of food prior to registration
Patients will be recruited through 28-30 surgeons located in 12 surgical practice sites within Michigan, Georgia, California, and Tennessee; patients will also be recruited at the University of Michigan (UM) Comprehensive Cancer Center
Vulnerable populations: there is no inclusion of fetuses, neonates, children, prisoners, institutionalized individuals, or others who may be considered vulnerable populations, except that it is possible that a subject might be pregnant
Patients must have a phone
Post-completion of treatment (may be on hormone therapy, such as tamoxifen, or monoclonal antibody, such as Herceptin or pertuzumab) for any type of cancer as confirmed by the medical record at MSKCC, by self-report, or by outside correspondence, including a study checklist signed by a physician for patients outside of MSKCC
PHASE II: If taking medication for mood, anxiety, depression, thoughts, sensory experiences such as hallucinations, or sleep, stable and consistent enough in dosage and use of that medication so as to not result in a clinically significant change as determined by the study principal investigator (Pl)/co-PI or confirmed by reports in the medical record at MSKCC, by serf-report, or by outside correspondence, including a study checklist signed by a physician for patients outside of MSKCC
Symptomatic carotid stenosis
Planning on remaining in the area for at least 1 year
CLINICIAN: Has an doctor of medicine (MD) or doctor of osteopathic medicine (DO) degree
Medical clearance from primary attending oncologist to undergo a symptom-limited CPET and aerobic training intervention
Willing to be randomized to one of the study arms
Cohort 1 participant: \r\n* Has neurocognitive impairment defined as performance on at least one measure of attention, memory, and/or executive functioning =< 10th percentile\r\n* Is absent of delayed sleep onset latency defined as an inability to fall asleep within 30 minutes < once a week during the past month
Cohort 2 participant:\r\n* Has neurocognitive impairment defined as performance on at least one measure of attention, memory, and/ or executive functioning =< 10th percentile\r\n* Has delayed sleep onset latency defined as self-report of an inability to fall asleep within 30 minutes >= once a week during the past month
Cohort 3 participant:\r\n* Is absent of neurocognitive impairment defined as performance > 10th percentile on all six measures of attention, memory, and executive functioning\r\n* Has delayed sleep onset latency defined as self-report of an inability to fall asleep within 30 minutes >= once a week during the past month
Self-identify as Latino
The planned procedure is a clean-contaminated (class II) case (includes gastric, small bowel, and colorectal resections, as well as bile or pancreatic duct transections)
Emergent cases will not be included in the study
Clean (class I), contaminated (class III) and dirty (class IV) procedures will likewise be excluded, as well as ones performed completely laparoscopically
The planned procedure involves foreign material (such as mesh or subcutaneous drains) being left in the subcutaneous space at the time of surgery (for example, a ventral hernia repair); surgical drains that are placed to drain an intraabdominal space and exit the abdominal wall remote from the incision are allowed in the study
Have glaucoma
Persons with congenital blindness and self-reported acquired blindness (independent of the cause) with no light perception
Patients with > 2 hours of direct exposure to outdoor natural light per day by interview with the Study Coordinator
Patients must have normal baseline self-reported taste perception prior to the development of colorectal or pancreatic carcinoma
Patients with a subjective history of an extreme dry mouth syndrome that prevents them from producing adequate amounts of saliva (approximately 2 mL in 15-20 min)
Vasopressor requirement
Concurrent hepatic veno-occlusive disease (VOD)
AYA is not married and has no children
Cancers not usually occurring in childhood/adolescent or young adult populations, such as lung or prostate cancer
Patients must have had two or fewer acupuncture treatments within the past 12 months for any reason except for joint symptoms; patients must not have had prior acupuncture treatment for joint symptoms at any time
Patients must be willing to submit blood and urine samples for serum hormones (estradiol, FSH, LH), inflammatory biomarkers (serum TNFalpha, IL-6, IL-12, CRP and urine CTX-II),urine AI metabolites, and deoxyribonucleic acid (DNA) analysis (CYP19A1), and must be given the option to consent to use of remaining specimens for future translational medicine studies; baseline samples must be obtained prior to beginning intervention
HSCT patients with either moderate or severe immunodeficiency based on immunodeficiency scoring system would be eligible for entry on study if a nasopharyngeal wash or throat swab specimen is positive by rapid RSV antigen testing and/or on culture within 72 hours (therapeutic arms)
HSCT patients with mild immunodeficiency based on immunodeficiency scoring system would be eligible for entry on study if a nasopharyngeal wash or throat swab specimen is positive by rapid RSV antigen testing and/or on culture within 72 hours but will not be randomized to therapeutic arms and will be followed as per standard of care (control arm)
Patients with evidence of RSV LRI as documented by a positive rapid RSV antigen testing and/or culture on nasal washes AND new or progressive infiltrates on chest radiographic studies suggestive of viral etiology and/or pulse oxygen less than 90 mm of Hg on room air
Patients with positive RSV by rapid antigen testing and/or culture in bronchoalveolar lavage regardless of the chest radiographic findings
Male partners of women who are pregnant (only for patients who are going to be randomized to either therapeutic arms)
Known vaginal pathology other than vaginal atrophy that could explain vaginal symptoms
Patients must not be planning to receive any of the following concomitant medications that can cause skin rash or other dermatologic reactions that could interfere with the EGFRI-induced skin toxicity assessments, for the duration of the study: allopurinol, systemic corticosteroids, topical retinoids (Retin-A, Tretinoin), oral retinoids (Amnesteem, Claravis, Sotret)
Rate fatigue at least 1 or higher on a scale of 0-10
Have a major contraindication to methylphenidate hydrochloride (MP) (e.g., allergy/hypersensitivity to study medications or their constituents), exercise (e.g., cardiac disease), cognitive behavioral therapy (e.g., schizophrenia), or conditions making adherence difficult as determined by the attending physician
Have glaucoma
Significant psychiatric or other co-morbid disease, which the treating clinician believes prohibits informed consent or participation in the study
Patients who were already seeing PC, or whose oncologists thought they needed to see PC or enroll in hospice
Rate fatigue on a numerical scale during the previous 24 hours as >= 4 on a 0 to 10 scale (0 = no fatigue and 10 = worst possible fatigue)
Patients with no stent lumen occlusion from mucus impaction as determined at the time of the initial visual bronchoscopic assessment
Patients needing anti-emetic treatment for breakthrough nausea/vomiting may also receive anti-emetic agents on an as needed (PRN) basis
Approval by oncologist or surgeon
Willingness to be randomized
Participating in another clinical study with competing study outcomes
Anatomically intact parotid and submandibular glands
Upper or lower extremity deformities that could interfere with accurate acupoint location or alter the energy pathway as defined by traditional acupuncture theory
No hereditary or idiopathic angioedema
Open or unhealed wounds or ulcers in the oral cavity
PEER MENTORS
PEER MENTORS:
This study is open to patients of all races and ethnicities
All patients undergoing planned open pancreaticoduodenectomy (PD) at Johns Hopkins Hospital (except pregnant women, adults lacking capacity to consent, non-English-speakers, and prisoners), irrespective of diagnosis, comorbidities, or administration of neoadjuvant therapy are eligible for this study
Transferrin saturation < 20% and ferritin < 50 ng/mL as assessed by the central laboratory during screening. Subjects must have both to be excluded (supplementation and retest acceptable).
Pre-registration screen of cognition is \severe\ or lower
Interested in reducing transfusion exposure
Clinical diagnosis of insomnia as identified through the screening Insomnia Severity Index score > 14
Ability to operate the accelerometer (Actiwatch Spectrum Pro)
Second or third shift workers or others with non-traditional sleep schedules
Sufficient mental capacity to answer SF-6D and Borg score questions
Chronic insomnia has been defined in previous research:as the presence of (1) three or more episodes of insomnia (i.e., ? 30minuteSOL, ? 60minute wake after sleep onset (WASO), or ? 6.5 hour total sleep time (TST) per night) of per week and (2) daytime effects of insomnia, such as irritability, difficulty concentrating, or fatigue for at least one month.
interested in behavioral sleep treatment
Active psychosis
Prior exposure to sotatercept
Patient who have reported fatigue moderate or higher fatigue (based on the 0-10 Fatigue scale, a fatigue score of 5 or higher) while on radiation treatment
Patient who have reported less than moderate fatigue (based on the 0-10 Fatigue scale, a fatigue score less than 5)
BFI score must meet at least one of the below criteria:\r\n* Total BFI < 50\r\n* Dietary subscale < 11\r\n* Frequency subscale < 19\r\n* Urgency subscale < 12
At the time of the wire stimulating procedure, patients will be excluded if the surgeon is unable to place the temporary stimulating lead
Inmates
Sexually active prior to cancer treatment (>= 17 on the Sexual Health Inventory For Men?[“SHIM”])
Patients with a history of left ventricular outflow obstruction (e.g., aortic stenosis, idiopathic hypertrophic subaortic stenosis)
Patients with retinitis pigmentosa
Patients with active thrombophlebitis
Known hypersensitivity to VPA, valproate sodium, disodium valproate, or any ingredient in the respective formulation
The following drugs will not be administered concurrently with VPA: carbapenem antibiotics; clonazepam; topiramate; felbamate; lorazepam; barbiturates; carbamazepine; chlorpromazine; ethosuximide; guanfacine; lamotrigine; methylfolate oxcarbazepine; paliperidone; phenytoin; primidone; protease inhibitors; rifampin; risperidone; rufinamide; salicylates; temozolomide; tricyclic antidepressants; vorinostat; zidovudine
Patients must have neuropathy greater or equal to 2 according to Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.0 scale, clinically evaluated within 30 days of consent, despite previous treatment, which may include Neurontin, Cymbalta and/or Lyrica for at least 30 days; patients receiving any of these drugs must remain on the same medications throughout the study period; however, adjustments in dosage are allowed; patients are allowed to stop medications but not replace them with other medications
Planned or actual changes in type of medications that could affect symptoms related to CIPN; new medications for the treatment of CIPN are not allowed during the study; Note: subjects need to be on stable doses for 4 weeks
Began adjuvant therapy with an aromatase inhibitor 12 to 18 months before survey sent out (Benchmark Survey only)
Has been in a stable sexual relationship of at least 6 months’ duration (Randomized Trial study only)
Women using systemic or vaginal estrogen, testosterone, or dehydroepiandrosterone (DHEA) during the Randomized Trial study will be excluded
Women using systemic or vaginal estrogen, testosterone, or dehydroepiandrosterone (DHEA) in the 12 months preceding the Benchmark Survey Study will be excluded
Patients with known thrombophilic risk factors; exception: patients for whom the potential benefits of participating in the study outweigh the potential risks of thromboembolic events, as determined by the investigator
Patients of East Asian ancestry (i.e., Chinese, Japanese, Taiwanese, or Korean)
Granulocytes >= 2,000/ml
Report sleep disturbance of 8 (sum total of all 7 items) or greater on the Insomnia Severity Index\r\n* (Note: this measure will be repeated again at baseline assessment)
Take medication for sleep (e.g., hypnotics and sedatives) every night; melatonin is permitted
Patients who are shift workers are excluded; shift worker is defined as someone who has irregular work and sleep hours (such as working a non-traditional schedule: e.g., 4pm-midnight or 10pm-6am; a rotating schedule e.g., alternating between day and night shifts, or starting work between 4am and 7am)
7+3: Standard-dose cytarabine 100-200 mg per meter squared continuous infusion for 7 days with idarubicin 12 mg per meter squared or daunarubicin 45-90 mg per meter squared for 3 days
High-dose cytarabine-based (HIDAC) chemotherapy administering a total cytarabine dose of ? 4 g per meter squared alone or in combination with other anti-leukemic agents (for example, anthracyclines, purine nucleoside inhibitors, etoposide, etc.)
Those with concurrent diagnosis of organic brain syndrome, dementia, mental retardation, non-English speaking, or significant sensory deficit
Underactive (defined as physically active for less than 30 minutes per day fewer than 2 days per week)
No restrictions or requirements will be placed on race
Patients with known fructose intolerance
INCLUSION CRITERIA FOR PATIENTS: Agrees to family member (family member; significant other; friend) participation in study and to selecting the individual who could participate
INCLUSION CRITERIA FOR FAMILY MEMBERS: No significant auditory or visual deficits with corrective devices
Spouses and patients must be married or cohabiting and in intimate relationship for at least 6 months
Have English as one of their languages of choice (they can be multilingual)
Presence of a sun tan in the area
Fitzpatrick skin types V, VI
Sufficient auditory acuity
Written informed consent obtained in accordance with institutional policies approved by the United States (U.S.) Department of Health and Human Services
Of any ethnicity
Endorse a moderate level of anxiety (e.g., greater than or equal to 8 on the Hospital Anxiety and Depression Scale [HADS-A])
At least 1 night of planned inpatient stay
Living in Maryland, Northern Virginia, or the Washington District of Columbia (D.C.) metropolitan area
Distressing cancer-related recollections that cause physiological reactivity
Any musculoskeletal problems that would interfere with the NET therapy
Are in the terminal stages of illness
Agree to travel to the Seattle Cancer Care Alliance (SCCA) or University of Washington (UW) School of Nursing for 2-3 in person assessments over the 12-13 weeks of the study
Neurologic disorders of stroke, encephalitis, dementia, epilepsy, Alzheimer’s disease, Parkinson’s disease
Self-report of learning disabilities
Visual impairments such as uncorrected vision or color blindness
Anticipate moving from the region in the next 4 months
Must be either morning or evening types (determined by Horne-Ostberg Morningness-Eveningness Questionnaire [MEQ])
Patients engage in shift work or travel across more than three time zones within three months prior to study
Patients take prescribed sedative hypnotics or sleep medications
Patients who have eye conditions (glaucoma or retinal disease), problems triggered by bright light (e.g. migraine), or take photosensitizing medications (e.g. some porphyrin drugs, antipsychotics, antiarrhythmic agents) will be excluded for safety of using bright light
Ownership of smartphone with following specifications: wireless capability, running on iPhone operating system (iOS) or Android operating system, current software (4.4 Android; 8.0 iOS or later), and, adequate memory to run the AMT program (43 megabyte[M] Android; 30.2M iOS)
Unfamiliar with mobile phones/tablets, including ability to download and register the Headspace app
Planned total laryngectomy at Barnes Jewish Hospital (BJH)
Subjects receiving the short-course fractionation radiation therapy (i.e., 16 sessions or 20 sessions at 2.4 to 2.6 Gy fractions per session, with or without boost)
Ability to come to standing from seated position without assistance
Adolescent gives assent
Patients with a DT level > 7 will be considered on a case-by-case basis
Immobility as defined by inability to ambulate unassisted
Must have cancer-related fatigue, as indicated by a response of 4 or greater when asked to rate their level of fatigue at its worst in the past week on an 11-point scale anchored by “0” = no fatigue and “10” = as bad as you can imagine
Have used marine omega-3 supplements at any time within previous 3 months (this includes prescription omega-3 drugs such as Lovaza®)
Participants must be a spouse or domestic partner of a cancer survivor and will be recruited via the Hematopoietic Stem Cell Transplant Database at Fred Hutchinson Cancer Research Center (FHCRC)
Tumor abutting main stem bronchus, main pulmonary artery branches, esophagus and/or trachea.
Women who self-identify as Black;
No active suicidality;
Women who do not self-identify as Black;
Active suicidality;
EXPERT PANEL:
A convenience sample of 10-15 experts (at least three lymphedema therapists and a varying number of HNC medical, radiation, and surgical oncologists, HNC nurse practitioners, speech and language pathologists, and nursing and informatics scientists) will be recruited to inform development of videos, protocol, and educational manual
Subsequent to the development of the materials, five additional therapists will be recruited to conduct an unbiased test of the therapists’ training video and protocol
A convenience sample of 10-15 HNC survivors (based on data saturation) will be recruited and interviewed about their status/needs for conducting lymphedema self-care; then, an additional 10 HNC survivors will be recruited to undergo a training session with the study therapist and test the patient video and educational manual
Using the same inclusion criteria as Stage 1 a convenience sample of 30 different HNC survivors will be recruited
Patients with medical conditions (e.g., acute infection, congestive heart failure, renal failure, cardiac or pulmonary edema, sensitive carotid sinus, severe carotid blockage, and uncontrolled hypertension) that would prohibit the safe implementation of home-based self-care of lymphedema will be excluded
Patients must regularly consume a diet with a glycemic load > 150 as estimated through the 3 day food recall
Patients must readily be available for a 3 month period and agree to participate in regular dietary adherence assessments (surveys and phone interviews)
Endoscopic procedures are contraindicated
Presence of a metal biliary stent
Patients plan to have primary surgery at either the University of Chicago Hospital or the University of Wisconsin Hospital
Patients with a suspected benign gynecologic process
Active disease relapse
Investigator is able to insert and deploy the Blowfish Catheter into the airway after recanalization
Patients will be free of signs and symptoms of infection at the time of entering the study and, most importantly, will be encouraged to have sufficient donors to administer prophylactic white cell transfusion twice a week for six weeks in order to assess their effectiveness
Patients with baseline (at start leukemia treatment) infection, defined as patients with fever and known positive cultures at the time of registration; or chest or sinus computed tomography with findings suggestive of pneumonia or sinusitis; or one positive galactomannan test >= 1 or two positive galactomannan test >= 0.5 to 1
Able to self-administer topical interventions or provide for another person to apply the topical interventions
Patients with pre-existing dermatologic condition affecting the face and chest that would impair assessment of papulopustular rash, including dense and/or long facial hair (per investigator discretion)
Ages 18-65 (women above the age of 65 may be included at principal investigator [PI] discretion)
Brief Fatigue Inventory (BFI) score of > 25
Inability to lay supine for one hour at a time, given the nature of the massage intervention
Subjects currently employing any other complementary and alternative medicine (CAM) manual therapy and/or holistic therapies to treat a perceived health problem; however, since past experience with CAM therapies should not confound any of the analyses of the experiments proposed in this study, we will not exclude individuals who have engaged in a CAM manual therapy in the past, nor will we exclude individuals who practice yoga or meditation for well-being, take vitamins or use nicotine
Active infectious disease excluding oral candidiasis
Requirement for concurrent treatment with nitrates or other drugs that may, in the judgment of the treating investigator, create a risk for a precipitous decrease in blood pressure
Subject answers item #1 of muscle spasms questionnaire as moderate or severe intensity at time of screening
Known deficiency in carnitine (genetic, etc.)
Patients requiring a chest wall boost
Any topical treatment for neuropathy or other serious skin condition on the hands or feet
Patients who have any confounding medical or neurological conditions that have the potential to affect cognition, speech or swallowing function; i.e. stroke, neurodegenerative disease, neuromuscular movement disorders, head injury, etcetera
Women who are being seen at the Women's Health Center by the Gynecologic Oncology group at the University of Minnesota if planned surgery includes an exploratory laparotomy
Have a response of > 3 or greater on a question assessing expected nausea as assessed on a 5-point Likert-scale anchored at one end by 1 = \I am certain I WILL NOT have this,\ and at the other end by 5 = \I am certain I WILL have this.\
Cognitive difficulties that preclude answering the survey questions, participating in the exercise classes or performance tests, or providing informed consent (confirmed by the professional opinion of the Principal Investigator, Dr. Kerri Winters-Stone)
Does not have internet and email access; note that survivors otherwise eligible, but excluded from full study participation because of this exclusion, will be asked to fill out a mailed copy of the baseline assessment for use in secondary aims analyses; they will be sent an information form and a copy of the tailored ‘My Health Action Plan’ health care guideline for transplant survivors also provided to randomized participants
Has received treatment for a recurrent or 2nd cancer that required > surgical excision in the past 2 years or did not have a hematologic malignancy or myelodysplasia diagnosis or did not receive a first transplant between 2-10 years before approach for the study; (these participants will be ineligible for randomization, but will have intervention site access if they complete baseline PRO assessment)
Residing in an institution or other living situation where health care decisions are not made by the participant (e.g., hospitalized, prisoners, living in a rehabilitation facility)
Does not complete baseline PRO assessment items required to determine stratification or whether the survivor meets inclusion and exclusion criteria
Treatment of reactivation or infection which is defined for each virus as below:\r\n* CMV: CMV antigenemia is monitored at least weekly post transplant; reactivation is defined at CMV antigenemia with < 10 leucocytes positive or elevated polymerase chain reaction (PCR); if any patient develops CMV antigenemia with > 10 leukocytes positive or clinical evidence of CMV infection (defined as the demonstration of CMV by biopsy specimen from visceral sites [by culture or histology]) either pre or after CTL infusions, standard treatment with ganciclovir, and/or foscarnet and immunoglobulins will be initiated; patients may receive CTLs alone for antigenemia or elevated PCR without visceral infection\r\n* Adenovirus: Adenovirus infection will be defined as the presence of adenoviral positivity as detected by PCR or culture from ONE site such as stool or blood or urine or nasopharynx; adenovirus disease will be defined as the presence of adenoviral positivity as detected by culture from more than two sites such as stool or blood or urine or nasopharynx; in patients who meet the criteria for disease cidofovir may be added unless the subject could not tolerate this agent due to nephrotoxicity; patients may receive CTLs alone for elevated PCR in blood or stool\r\n* EBV: EBV-lymphoproliferative disease (LPD) is defined according to recent guidelines as proven EBV-LPD defined by biopsy or probable EBV-LPD defined as an elevated EBV deoxyribonucleic acid (DNA) level associated with clinical symptoms (adenopathy or fever or masses on imaging) but without biopsy confirmation; patients with EBV DNA reactivation only may receive CTLs on study; patients with proven or probable EBV-LPD should also receive Rituxan\r\n* BK virus: Patients post transplant may develop asymptomatic BK virus (BKV) viruria or viremia; BK reactivation will be defined as detection of elevated BK levels by PCR in blood or urine while disease will be defined as detection in multiple sites or in one site with symptoms; cidofovir has been administered intravenously in a low dose (i.e. up to 1 mg/kg 3 times weekly, without probenecid) or a high dose (ie, 5 mg/kg per week with probenecid) to HSCT patients with BK infections but no randomized trials are available proving its clinical efficacy; in patients who meet the criteria for disease cidofovir may be added unless the subject could not tolerate this agent due to nephrotoxicity\r\n* HHV6: HHV6 reactivation will be defined as detection of elevated HHV6 levels by PCR in blood while disease will be defined as detection in multiple sites or in one site with symptoms; ganciclovir, cidofovir, and foscarnet have variable in vitro activity against HHV-6, and may have a role in treating HHV-6-associated disease – hence one or more of these agents will be added in patients with disease
Available multivirus-specific CTLs
Cyclosporine (CSP)-based postgrafting immunosuppression
Participant has symptoms of NP/PN with onset within 7 days after one of the following vincristine doses +/- 3 days: protocol week 1 or week 2 (induction), week 7 (reinduction I), or week 17 (reinduction II)
Cryoablation should be performed within 14 days of baseline evaluations
Anticipated treatment of the index tumor that would require iceball formation within 1.0 cm of the spinal cord, brain, other critical nerve structure, large abdominal vessel such as the aorta or inferior vena cava, bowel, or bladder
The subject is willing to consent to randomization to the intraperitoneal drain vs. no drain group
The subject is not willing to consent to randomization to the intraperitoneal drain vs. no drain group
Anaphylaxis to local anesthetics or narcotics
Patients requiring additional intra-operative skin resections of greater than 1 cm beyond the skin edge as a result of mastectomy flap devascularization
Able to ambulate
Cognitively intact
Adequate visual accuracy allowing eye testing
Fitzpatrick skin type I-VI
All ABO blood group combinations of the donor/recipient are acceptable since even major ABO compatibilities can be dealt with by various techniques (red cell exchange or plasma exchange)
Able to be accompanied by their spouse or significant other partner/friend (spouse, significant other, partner, or friend)
Must be right handed
N0
M0
Subject meets the following medication restriction requirements and agrees to follow medication restrictions during the study; the following concomitant medications are not allowed: cyclophosphamide, abatacept, etanercept, adalimumab infliximab, golimumab, tofacitinib, and alemtuzumab; these medications also cannot have been used for 5 half-lives prior to enrollment
Patients must have neuropathy greater or equal to 2 according to Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 scale despite previous treatment, which may include Neurontin, Cymbalta and/or Lyrica; patients receiving any of these drugs must remain on the same medications throughout the study period; however, adjustments in dosage are allowed; patients will be removed from the study if a change in type of medication is necessary; patients are allowed to stop medications but not replace them with other medications
Mental incapacitation or significant emotional or psychological disorder that, in the opinion of the investigators, precludes study entry (these patients may not be able to cooperate with this slightly invasive procedure or with the data collection process)
Currently pregnant (certain acupuncture applications have been reported to stimulate uterine contractions)
Planned or actual changes in type of medications that could affect symptoms related to peripheral neuropathy (PN); new medications for the treatment of chemotherapy-induced peripheral neuropathy (CIPN) are not allowed during the study; Note: subjects need to be on stable doses of CIPN medications for 4 weeks
All cancer patients > 18 years of any ethnicity who have been treated with intravenous zoledronate (zoledronic acid) for >=1 year duration
Clinical diagnosis of BRONJ subsequent to oral surgery as established by standard clinical protocol per American Association of Oral and Maxillofacial Surgeons (AAOMS) diagnostic criteria
Planned course of definitive or post-operative radiotherapy (RT) to a total dose of ? 60 Gy using 1.8 to 2.0 Gy per fraction
At least one third of the oral cavity mucosa must be included in the RT fields, as estimated by the treating radiation oncologist
Willing to abstain from ingestion of yogurt products and/or any product containing probiotics during study drug treatment
Split-course RT is planned
Watch less than 3 hours of television per day
Willing to abstain from ingestion of yogurt products and/or any product containing probiotics during study drug treatment
Split-course RT is planned
Note: Post-surgical patients should proceed to registration immediately following preregistration
GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: Agent specific limitations on prior therapy will be included with specific treatment subprotocols
Breast density will be determined by prior mammography reports, when available, or by radiologist review of prior imaging; all other risk factors used to determine patient eligibility for annual or biennial screening will be determined by subject self-report
Have a smartphone
Have access to a healthcare provider and be willing to share genetic results with that provider
Have at least one ovary
Have a valid United States mailing address for receipt of saliva kit
CESM studies will include at least four low energy and four recombined images (left craniocaudal [LCC], left mediolateral oblique view [LMLO], right craniocaudal [RCC], right mediolateral oblique [RMLO])
MRI exams will include at least fluid sensitive sequence, multi-phase T1-weighted images
Rural Appalachian resident
Palpable nodule in both lobes of the prostate or evidence of extra-prostatic disease
Patients with underlying dementia (or on medications to treat Alzheimer’s disease such as donepezil, rivastigmine, galantamine, tacrine, or memantine), encephalopathy, or other neurological disorder known to adversely affect cognition (such as epilepsy or prior stroke) are excluded; (patients with depression or anxiety are not excluded)
Patients will be excluded from functional magnetic resonance imaging (fMRI) testing if they are left-handed, claustrophobic, have a pacemaker, or have metal implants; patients not fMRI testing may still enroll in clinical trial, including the event related potentials (ERP) testing, if all other eligibility criteria are met
One or more SYHC visits in the last year
Not up­-to-­date with screening (up to date with screening will be defined by Healthcare Effectiveness Data and Information Set [HEDIS] and Uniform Data System [UDS] criteria, which require presence of guaiac fecal occult blood test [gFOBT]/fecal occult blood test [FIT] in the last year, sigmoidoscopy in the last 5 years, or colonoscopy in the last 10 years)
Insured by MediCal, Medicare, or private health insurance
Uninsured
HIV positive individuals seeking dental care at Bering Omega/Houston Area Community Services
Patients declining oral biopsies
Be non-adherent to one or more recommended screenings for BC, CC, or CRC by Medical Record Review (MRR)
Reside in one of 32 rural counties in Indiana (IN) or Ohio (OH)
Plan to move outside of the country within the next year
Subjects are scheduled for colposcopy clinic based on screening with abnormal pap smear or have repeat colposcopy indicated for specific clinical indications, based off of the most recent American Society of Colposcopy and Cytology guidelines
Uninsured or on public Medicaid insurance
Women with heterogeneously dense or extremely dense parenchyma by prior digital mammography report (i.e., \dense breasts\), presenting for routine annual mammography with digital breast tomosynthesis
Signs or symptoms of breast disease including lump, bloody or spontaneous clear nipple discharge, eczema of the nipple
Patients with active esophagitis
No requirement for sedation
Patients must also have a treatment plan that includes liver function assessment with indocyanine green (IC-GREEN)
Must be willing to have height and weight recorded at each aspiration visit
If applicable, must be willing to collect a stool specimen and bring to the clinic; special collection kits will be provided
Metastatic malignancy to other organs, excluding Hodgkin’s or non-Hodgkins lymphoma
Prior partial or total gastrectomy with Billroth II or Roux-en-Y anastomosis
Significant damage or deformity to the feet that would alter blood flow or make it impossible to measure/interpret findings;
Diagnosis of restless leg syndrome or other movement disorders that would prevent accurate data from being able to be collected.
PRE-TEST: Adults who can meet with Research Staff at Washington University in St. Louis in-person to complete study requirements
PRELIMINARY TEST: Ages 18-65
Resident of an Ohio Appalachia county
Have a terminal medical illness that would otherwise categorize them as inappropriate candidates for CRC screening; these are: the individual must have any of the following noted in their EPIC electronic medical records (EMR): personal history of CRC, colectomy, colostomy, or ileostomy
Have cystic fibrosis
Are insured by the Colorado indigent care program (CICP) or Medicaid-Old age pension, American Association of Retired Persons (AARP) Medicare/Secure Horizons (except private fee-for-service [PFFS]), Denver Health Managed Medicaid, Evercare; Kaiser (not the prescriber of origin), Medicare Complete, New Medicaid, New CICP
Haitian, Hispanic, or African American
Live in the cities of Miami/Little Haiti, Hialeah or unincorporated southern Miami-Dade
Plan to move outside of Miami-Dade county during the next six months
Patients with any clinical symptoms (palpable mass, nipple discharge, etc)
Community physicians, colorectal cancer survivors, family advocates, researchers, and representatives of community-based organizations
Patients who have no plans to move out of the region in the next 12 months
Patients who are scheduled for a routine appointment with participating providers, who would utilize a guide to aid in decision making for prostate cancer screening, specifically men ages 40-69
Patients are not smokers
Patients are smokers
Acknowledge sex with men in lifetime
Reside in Harris County, Texas
Be self-identified as Latino/Hispanic
Women with pacemakers
Received treatment of cervical dysplasia with LEEP, cone biopsy, laser procedure or cryotherapy within THREE years
Patients with history of segmental resections are eligible (i.e. right colectomy, extended right colectomy, transverse colectomy, left colectomy, extended left colectomy, sigmoid colectomy, low anterior resection, abdominoperineal resection); the definition of resection does not include endomucosal resection (EMR); patients that have received total proctocolectomy are ineligible\r\n* In addition to segmental resections, the following types of procedures are allowed: polypectomy: for Tis (stage 0) or pT1 patients only, resection may consist entirely of polypectomy (without completion of partial colectomy) if ALL of the following criteria are met:\r\n** Single specimen, completely removed\r\n** Clear margins\r\n** None of the following must be present:\r\n*** Moderate or poor differentiation\r\n*** Lymphovascular invasion\r\n*** Perineural invasion\r\n* Transanal excision is allowed for pT1 rectal cancer patients with well or moderately differentiated tumors if National Comprehensive Cancer Network (NCCN) criteria for transanal excision are met, as stipulated here:\r\n** < 30% circumference of bowel\r\n** < 3 cm in size\r\n** Margin clear (> 3 mm)\r\n** Mobile, nonfixed\r\n** Within 8cm of anal verge\r\n** T1 only\r\n** Endoscopically removed polyp with cancer\r\n** No lymphovascular invasion or perineural invasion\r\n** Well to moderately differentiated\r\n** No evidence of lymphadenopathy on pretreatment imaging\r\n***When the lesion can be adequately identified in the rectum, transanal endoscopic microsurgery (TEM) may be used; TEM for more proximal lesions may be technically feasible
Patients must have a pure tone audiometry evaluation to document air conduction within 30 days prior to registration; patients with hearing loss > 40 dB in any of the five tested frequencies (250 Hertz [Hz], 500 Hz, 1,000 Hz, 2,000 Hz, 4,000 Hz) are not eligible; patients with active ear infections should be tested only after the acute phase of infection has resolved; for optimal results, it is recommended that testing be conducted by an audiologist, in a hearing test room, with insert earphones; Note: sites should not order audiometry evaluation until the potential participant has met all other eligibility criteria required for this study
A total WBC >= 3.1 x 10^3/mcL is allowed for non-Hispanic black males (NHBM) and total WBC >= 3.4 x 10^3/mcL for non-Hispanic black females (NHBF) \r\n* Exception: If the WBC is lower than the above levels, the patient may be enrolled IF the absolute neutrophil count (ANC) is >= 1.3 for NHBM, >= 1.4 for NHBF, or >= 1.5 for all.
Patients must be willing to provide name and appropriate telephone contact information and be willing to be contacted periodically via telephone by The University of Arizona Cancer Center (AZCC) staff for completion of individualized lifestyle intervention coaching, completion of the Pittsburgh Sleep Quality Index, and for clarification of patient-completed responses if necessary; patient must be willing to have Arizona Food Frequency Questionnaire (AFFQ), Arizona Physical Activity Questionnaire (APAQ), baseline questionnaire, and personal contact information sent to AZCC
Vegan vegetarians
Sustained or symptomatic ventricular dysrhythmias uncontrolled with drug therapy or implantable device
Able to hold breath for 10 seconds
CONTROL (HEALTHY) GROUP: Able to hold breath for 10 seconds
Biopsy-proven anal HSIL at baseline (anal intraepithelial neoplasia [AIN]2 with a positive cyclin-dependent kinase inhibitor 2A [p16] stain, AIN2-3, or AIN3)
Warts so extensive that they preclude the clinician from determining the extent and location of HSIL
Receiving pyrimethamine, cimetidine, rifampin or cephalexin
Confirmed acute index (original venous thrombotic) event: lower extremity or upper extremity (jugular, innominate, subclavian, axillary, brachial) DVT, PE, splanchnic (hepatic, portal, splenic, mesenteric, renal, gonadal), or cerebral vein thrombosis for which the patient has received >= 180 days (but =< 365 days) of anticoagulant therapy prior to registration; the date, imaging modality, and location of index event will be required; the date of initiation and specific type of anticoagulants used will also be required
Mechanical heart valve
Documented hemorrhagic tendencies (e.g., hemophilia)
Bacterial endocarditis
primary bone malignancies or aggressive benign bone tumors of the femur or tibia, soft-tissue sarcomas which have invaded the femur or tibia, or oligometastatic bone disease of the femur or tibia in a patient expected to live at least one year post-operatively; and
treatment by surgical excision and endoprosthetic replacement of the femur or tibia.
documented anaphylaxis or angioedema to penicillin or cefazolin (Ancef);
prior local infection within the surgical field of the affected limb;
Available for duration of study
History of any upper gastrointestinal (GI) surgery that does not permit access to or evaluation of a 10 cm segment of the duodenum that includes the duodenal bulb, i.e. whipple procedure or similar
Urinary testing results within institutional limits of normal or deemed clinically insignificant
Spigelman 2?3
Presence of at least 1 fallopian tube and 1 ovary; (please note: prior unilateral salpingectomy is allowed; prior bilateral salpingectomy is not allowed)
Patients must understand that they will be permanently sterilized
Women with elevated levels of CA125 (> 50) or transvaginal ultrasound suggesting cancer, unless findings are consistent with endometriosis; CA125 and transvaginal ultrasounds must be the most recent, but no older than 1 year from the date of enrollment
Anticipated desensitization treatment; this decision to exclude will be based on the site clinician’s judgement; desensitization procedures vary somewhat among the five participating transplant centers, which does not permit proposing uniform criteria across all study sites for determining exclusion due to desensitization; in general, women who have received a prior transplant, have unsuitable scores on Calculated Panel Reactive Antibody (PRA) percentage (institution-specific thresholds), or an ABO incompatible donor are likely to undergo desensitization at one or more of the study centers; these factors, among others, will be used by the study clinician to determine exclusion due to anticipated desensitization in the study
Participants who cannot have their warfarin, Lovenox, Plavix, or other comparable medications held for percutaneous or transjugular liver biopsy and surgery if so indicated
Available for duration of study
Mammographically dense breast (heterogeneously dense [C] or extremely dense [D], based on American College of Radiology [ACR] BIRADS fifth edition classification or heterogeneously dense [3] or extremely dense [4], based on ACR BIRADS fourth edition classification) in either breast
Willingness to avoid exposing breast skin to natural or artificial sunlight (i.e. tanning beds) for the duration of the study
Documented evidence of fibrosis or cirrhosis (Metavir 2, 3, and 4) and subjects with significant extrahepatic manifestations of hepatitis C (such as cryoglobulinemia with symptoms or evidence of end-organ manifestations, renal disease, type 2 diabetes, or porphyria cutanea tarda
Screening HCV genotype, demonstrating genotype 1
LVEF >50%, or an LVEF within the normal limits of the institution's specific testing (MUGA or ECHO)
Active pulmonary disease requiring medication to include multiple inhalers (>3 inhalers including one containing steroids)
Presence of gallstones and hypertriglyceridemia (level greater than 800 mg/dl) that requires medical or surgical intervention; note: we will include patients who had an independent episode of pancreatitis after a cholecystectomy, but exclude patients who are candidates for cholecystectomy
Recurrent pancreatitis episode is iatrogenic (endoscopic retrograde cholangiopancreatography [ERCP] induced)
Patients with any pulmonary infiltrate including those suspected to be of infectious origin (unless resolves to ? Grade 1 within screening timeframe)
Positive FOBT during the study period
No medical contra-indication for colonoscopy
Women must indicate that they are still considering future pregnancy and childbearing
Women must be willing to take supplemental omega-3 fatty acids provided by the study
Computed tomography (CT) scan of the chest done =< 6 months prior to pre?registration showing either negative findings (no nodules) or solid or part?solid nodules < 6 mm in size (consistent with < 1% probability of malignancy, Lung?Reporting and Data Systems [RADs] version 1.0)
FOCUS GROUP: Not able to speak and read English; not able to physically attend the focus group location and time, women who do not wish to be contacted or involved in research, women who have died between mammogram and recruitment data pull date, and women who have disenrolled from Group Health between mammogram and pull date
BETA/USABILITY TESTING AND THE TRIAL: who have disenrolled from Group Health between her mammogram and the record pull date, who have died, and those who have indicated that they do not want to be contacted for research, if they participated in our previous intervention development activities, or if they died or disenrolled from health plan between mammogram and start of recruitment
Prior cholangiocarcinoma
Self-described betel nut chewer (chewed betel nut for at least 3 years, and at a rate of at least 3 days per week); must be class 2 betel nut chewers: that is, must chew a quid consisting of areca nut, slaked lime, betel leaf, tobacco, and other optional ingredients, and not swallow the quid
Chews betel nut alone (i.e., without quid)
One or more Padua-based risk factor:\r\n* History of previous venous thromboembolic event (excluding superficial vein thrombosis)\r\n* Reduced mobility (Eastern Cooperative Oncology Group [ECOG] performance status 3 or 4)\r\n* Established hereditary thrombophilia (e.g. Factor V Leiden, G20210 prothrombin mutation, protein C or S deficiency, antithrombin deficiency)\r\n* Recent surgery within the last 30 days\r\n* Age >= 70 years\r\n* Congestive heart failure (New York Heart Association [NYHA] class III or IV)\r\n* Complicated respiratory insufficiency (defined as an increased requirement for supplementary oxygen of at least 2L)\r\n* Acute myocardial infarction or ischemic stroke\r\n* Obesity (body mass index [BMI] >= 30)\r\n* Receiving hormonal agents (e.g. tamoxifen, estrogen, testosterone)\r\n* Acute infection (i.e. requiring antimicrobial therapy)
Bacterial endocarditis
RECIPIENT: Alemtuzumab or any equivalent in vivo T?cell depleting agent
Ability to take digital time stamped photos.
Currently own an iOS mobile phone (iPhone) using iOS 9.0 or later and reports regular use (at least weekly) of at least 1 iOS app
WHITE, NON-HISPANIC: Study participants will not have had a skin examination within the last year and will be of European ancestry. The study sample will be limited to non-Hispanic whites because i) skin type is the overwhelming risk factor for cutaneous melanoma resulting in very low incidence of this disease among persons who are black, Asian, Native American or Pacific Islander, and ii) the prior genetic investigation upon which this application is based was undertaken in a non-Hispanic white population. Thus at this time, inference of genetic risk attributable to MC1R variants is unknown for individuals not identifying as non-Hispanic white eliminating any direct inference of the proposed intervention to a non-Hispanic white population.
HISPANIC/LATINOS (H/L): Self-report Hispanic ethnicity (there will be no exclusions based on reported race).
WHITE, NON-HISPANIC: Participant whose medical records or self-report indicate any race or ethnicity identification aside from white, non-Hispanic.
Individuals who are status post total proctocolectomy (i.e. removal of all colon and rectum).
Patients already on AED(s)
Expired carbon monoxide reading >= 6.
At least marginal health literacy.
Physically unable to wear equipment and provide a good reading of physiological measures.
No prior experience with a smart phone.
Under active surveillance
Severe neuromusculoskeletal conditions that limit their ability to perform walking exercise (including ataxia, peripheral or sensory neuropathy, unstable bone lesion, severe arthritis, lower limb fractures within 6 months, lower limb amputation)
Not compliant with recommended sun protection, as determined by at least one of the following criteria:\r\n* Any intentional sunbathing, artificial tanning or a sunburn in the past 5 years\r\n* Having a moderate to light complexion (Fitzpatrick skin types I-IV) and not using sunscreen >= 90% of the time during incidental sun exposure
Enrolled on Dana-Farber Cancer Institute (DFCI) protocol 17-385 or any other sun protection intervention in the past 5 years
Considered eligible for Ohio Expanded Food and Nutrition Education Program (EFNEP) income guidelines
Located in the greater Cleveland metropolitan area
Answers ‘no’ to all questions on the PA Readiness Questionnaire (PAR-Q) or is cleared in writing by a physician
Ability to avoid exposure of the treated breast area to sunlight and artificial ultraviolet light during the use of bexarotene gel
Dietary vitamin A intake >= 5,000 IU/day (as determined by dietary supplementation)
All newly referred patients to colposcopy clinic at Siteman Cancer Center at Washington University (SIUM) and Washington University School of Medicine (WUSM)
Women will be excluded if they are established colposcopy clinic patients, have a known diagnosis of cancer; are pregnant, incarcerated, or unable to consent; or do not have access to a working contact phone number
HIV-1 infection, documented by one of the following any time prior to study entry:\r\n* Any licensed rapid HIV test\r\n* HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit; and confirmed by one of the following:\r\n* Licensed western blot\r\n* Second antibody test by a method other than the initial rapid HIV and/or E/CIA\r\n* HIV-1 antigen\r\n* Plasma HIV-1 RNA viral load\r\n* Documentation of receipt of antiretroviral therapy\r\n* Note: the term “licensed” refers to a kit that has been certified or licensed by an oversight body within the participating country and validated internally; WHO (World Health Organization) and CDC (Centers for Disease Control and Prevention) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment; a reactive initial rapid test should be confirmed by either another type of rapid assay or an E/CIA that is based on a different antigen preparation and/or different test principle (e.g., indirect versus competitive), or a western blot or a plasma HIV-1 RNA viral load
Prior treatment for cervical HSIL\r\n* Note: Cervical scarring that occurs after treatment with cryotherapy or LEEP may impact future visual evaluation of the cervix, making visual inspection with acetic acid (VIA) or colposcopy more challenging
Cervical, vulvar, or vaginal lesions suspicious for cancer based on clinical appearance (e.g. necrotic, ulcerated, and/or fungating masses), unless biopsies show no invasive cancer
Possession of smart phone capable of running MyFitnessPal and Garmin Connect apps and willing to have diet and exercise data accessed by study personnel; access to a personal computer\r\n* In general Android, Apple products and Windows 10 phones or any phone with Bluetooth Smart, will run Garmin Connect; (iPhone 5,5s,6,6s,7,7+; most recent Motorola, Samsung, Google Nexus, Sony, and Nokia products)
Live in the greater Kansas City metropolitan area
Planned allogeneic HCT using fludarabine phosphate (FLU)/melphalan hydrochloride (MEL) or FLU/busulfan (BU) conditioning
Subjects will be eligible if their planned post grafting immunosuppression consists of one of the two following regimens:\r\n* TAC/MTX: tacrolimus (oral or intravenous) and intravenous methotrexate administered according to institutional standard practice.\r\n* TAC/SRL: tacrolimus (oral or intravenous) and oral sirolimus, administered according to institutional standards of care
Interest and willingness to commit to the 8 week Getting Ahead training program that will occur over 16 sessions occurring twice a week
If the patient is female, she shall: a) not have attained menarche yet or b) have attained menarche and have a negative pregnancy test at the screening visit and at Day
Patient who received any drug with potential anti-emetic effect within 24 h prior to the start of reference chemotherapy, including but not limited to: NK1- receptor antagonists (e.g., aprepitant or any other new drug of this class); 5-HT3 receptor antagonists (e.g., ondansetron, granisetron, dolasetron, tropisetron, ramosetron); Benzamides (e.g., metoclopramide, alizapride); Phenothiazines (e.g., prochlorperazine, promethazine, perphenazine, fluphenazine, chlorpromazine, thiethylperazine); Benzodiazepines initiated 48 h prior to study drug administration or expected to be received within 120 h following initiation of chemotherapy, except for single doses of midazolam, temazepam or triazolam; Butyrophenones (e.g., droperidol, haloperidol); Anticholinergics (e.g., scopolamine, with the exception of inhaled anticholinergics for respiratory disorders e.g., ipratropium bromide); Antihistamines (e.g., diphenhydramine, cyclizine, hydroxyzine, chlorpheniramine, dimenhydrinate, meclizine); Domperidone; Mirtazapine; Olanzapine; Prescribed cannabinoids (e.g., tetrahydrocannabinol, nabilone); Over the Counter (OTC) antiemetics, OTC cold or OTC allergy medications; Herbal preparations containing ephedra or ginger.
Current and former tobacco users are eligible; the tobacco use assessment form must be completed following consent, to assure eligibility; patients must have >= 10 pack-year cumulative tobacco exposure or its equivalent to be eligible; this is defined as follows:\r\n* Cigarette exposure: >= 10 pack-years OR\r\n* Cigar exposure: >= 10 cigar-years, where 1 cigar year is defined as having smoked on average >= 1 cigar/day for a year OR\r\n* Chewing tobacco: >= 10 snuff-years, where 1 snuff year is defined as using on average >= 1 pinch (dip) of chewing tobacco/day for a year
Individuals who are willing to limit sun exposure to the body during the study period, and who agree to wear protective clothing and sun protection factor (SPF) 50 broad spectrum sunscreen or sunblock on exposed skin when they are outdoors
A subgroup of Individuals with 4 benign melanocytic nevi (BN) measuring at least 6 mm in diameter and with evidence of benign features by epiluminescence microscopy (ELM) will be included in the study; these criteria will be considered optional and applicable when the 4 BN are present in surgically accessible areas
Individuals must not take mega-doses of vitamins; mega-doses are defined as more than 5 capsules of standard multivitamins daily or more than the Tolerable Upper Intake Levels of Vitamins, as defined by the Institute of Medicine, National Academy of Sciences; such vitamin therapy must be discontinued at least 30 days prior to study entry
Individuals with Fitzpatrick skin type I are ineligible
Individuals with Fitzpatrick skin type V or VI are ineligible
Proven or probable aspergillosis or other mold infection or deep mycoses including hepatosplenic candidiasis less than 60 days from first dose of isavuconazole (ISA)
Time interval of at least 6 days duration where complications such as rejection episodes, viral infections, surgical interventions and therapies with mono or polyclonal antibodies are ruled out by the transplant team
Be willing to forego other interventions in the treatment fields than the ones approved by the investigator that would interfere with the protocol or evaluation of the study medication
Patients with Fitzpatrick’s scale skin type IV-VI
Their vision should be normal or corrected-to-normal (to ensure that they can accurately see the images on the screen and select the appropriate response)
Serious medical illness unsuitable for the MR scanner based on best clinical judgment
Smokes first cigarette within 90 minutes after waking
Their vision should be normal or corrected-to-normal (to ensure that they can accurately see the images on the screen and select the appropriate response)
Willing to be randomized
Self-identification as Black/African American
Permanent contact information
Laparoscopic or robotic pancreaticoduodenectomy
Co-medications that may interact with rolapitant (e.g. metoprolol/beta blocker, codeine, pimozide thioridazine) as reviewed by Duke Preston Robert Tisch Brain Tumor investigator pharmacist
Ongoing vomiting from any organic etiology
Patient has taken the following agents within the last 48 hours prior to the start of treatment with study drug:\r\n* 5-hydroxytryptamine (HT3) antagonists (ondansetron, granisetron, dolasetron, tropisetron, etc.); palonosetron is not permitted within 7 days prior to administration of investigational product\r\n* Benzamides (metoclopramide, alizapride, etc.)\r\n* Domperidone\r\n* Cannabinoids\r\n* Neurokinin-1 (NK1) antagonist (aprepitant)\r\n* Benzodiazepines (lorazepam, alprazolam, etc.)\r\n* Herbal medications or preparations in doses designed to ameliorate nausea or emesis
Live in the greater Kansas City metropolitan area
Participants that are unable to provide a mailing address within the mainland United States or Puerto Rico, or are unable to provide a mailing address (i.e., do not have one), will be excluded from participating in the study
Not be allergic to soy or soy related products
Oriented to person, place, and time
Uses a walker or wheelchair/scooter
Lives outside the greater Houston area (Harris and contiguous counties)
Is pregnant (self-reported)
Total colectomy
Fecal incontinence
Intolerance of warm air stimulus as demonstrated by profound vertigo and nausea
Prior otologic surgery beyond tympanostomy tubes, including, but not limited to, tympanomastoidectomy, cochlear implant, endolymphatic shunt, mastoidectomy, osseous-integrated hearing device
Baseline asymmetric hearing loss (defined by 1) >= 10-dB interaural threshold difference at 3-octave frequencies (250-8,000 Hz), 2) >= 15-dB difference at 2-octave frequencies, and 3) > 15-dB difference at 1-octave frequency)
Active carcinomas or melanomas of the skin of the face, scalp, ear, and neck
Prior melanomas of the skin of the face, scalp, ear, and neck, which are less than 5 years from surgical excision
CHILDREN
Expired-air carbon monoxide (CO) > 8 ppm (if =< 8 ppm, then NicAlert Strip > 2)
Positive urine screen for cocaine, opiates, methadone, benzodiazepines, barbiturates, amphetamines, methamphetamines, or phencyclidine (PCP) (NOTES: tetrahydrocannabinol [THC] will be tested but will not be an exclusionary criterion; participants with valid prescriptions for opiates, benzodiazepines, barbiturates, amphetamines or methadone will not be excluded; participants failing the toxicology screen will be allowed to re-screen once)
Currently taking the following medications:\r\n* Phenytoin (brand name: Dilantin)\r\n* Carbamazepine (brand name: Tegretol, Carbatrol, Equetro, Epitol)\r\n* Oxcarbazepine (brand name: Trileptal)\r\n* Primidone (brand name: Mysoline)\r\n* Phenobarbital\r\n* Bendamustine (Treanda)\r\n* Clopidogrel (Plavix)\r\n* Clozapine (Clozaril, FazaClo)\r\n* Erlotinib (Tarceva)\r\n* Flecainide (Tambocor)\r\n* Fluvoxamine (Luvox)\r\n* Irinotecan (Camptosar)\r\n* Olanzapine (Zyprexa)\r\n* Ropinirole (Requip)\r\n* Tacrine (Cognex)\r\n* Theophylline (Theo Dur, etc.)
Helicobacter pylori negative, defined as negative stool antigen testing and negative histological examination
Patients who are premenopausal defined as an individual with at least six menstrual cycles in the past year\r\n* Women with hysterectomy with intact functioning ovaries who are not having menstrual cycles need to be 45 years of age and under
Inflammatory or exfoliative skin diseases such as eczema, psoriasis that disrupt epidermis
Patients with active Clostridium difficile infection at the time of study enrollment; active infection is defined as a stool sample positive for Clostridium difficile toxin via enzyme immunoassay (EIA) and either symptoms (frequent loose stools) OR imaging findings consistent with toxic megacolon
Willing to abstain from cannabis and other tobacco products during study procedures
If previously on oral contraceptives or hormone replacement, off for 8 weeks or more prior to baseline RPFNA; the exception is low dose vaginal hormones (estring, vagifem, or 0.5 gram or less of conjugated estrogen vaginal cream twice weekly or less often); these vaginal preparations may be continued at the same dose
An RPFNA performed less than six months prior to enrollment on study that exhibits at least 500 cells on the cytology or Ki-67 slide, and a Ki-67 positivity measured on at least 500 cells that is less than 4%
RPFNA criteria:\r\n* Cells suspicious for malignancy
For patients that present to clinic to have a cervical excisional procedure (LEEP) for an already confirmed diagnosis of high grade cervical dysplasia, HRME imaging study will be performed and cervical biopsies might be taken for research purposes only; any extra biopsies taken will be for research purposes only and our research fund will pay them
Planning on remaining in New York City (NYC) for at least 9 months (with no vacations or trips to exceed two months)
Licensed taxi driver for at least 3 months
Part-time driver (drives fewer than 35 hours per week); although it is highly unlikely for NYC taxi drivers to work for multiple garages at study baseline, drivers may switch jobs and/or their garage base affiliation while participating in this study; new jobs and/or garage base affiliations will be tracked during follow-up assessments and noted for potential limitations with study retention and intervention contamination; drivers will be allowed to continue the study even if they are no longer working with the initial garage base
Currently owns a cell phone, uses text messaging services and is willing to accept text messages for this study
Will not be in the New York city (NYC) area for the duration of the study period (6-9 months)
Smoking 5 or more cigarettes, little cigars or cigarillos per day, on average, within the 2 months preceding the screening visit and expired carbon monoxide (CO) greater than or equal to 6 parts per million (ppm); (if < 6, then NicAlert Strip > 2)
Individuals rated as moderate (9-16) to high (17 or greater) on suicidality as assessed by module B of the MINI
Unwilling to change hairstyle or remove a wig as necessary for the appointment to accommodate the net that is required to be worn on the scalp during the study procedure
Positive toxicology screen for any of the following drugs: cocaine, opiates, methadone, benzodiazepines, barbiturates, amphetamines, methamphetamines, or phencyclidine (PCP)\r\n* Participants with valid prescriptions for opiates, benzodiazepines, barbiturates, amphetamines or methadone will not be excluded\r\n* Participants failing the toxicology screen will be allowed to re-screen once; if they test positive again, they will not be allowed to return for 90 days
Patients with symptomatic cholelithiasis
Direct bili =< 1 x ULN
Have used smokeless tobacco for the last year, currently (past 30 days) uses smokeless tobacco daily, and chews/dips at least 3 times a day
Have an address in a rural census tract defined by a Rural-Urban Commuting Area (RUCA) code of 4-10 or reside in a county with an Urban Influence Code of 4 or higher or live in a medically underserved area defined as an Index of Medical Underservice (IMU) of 62 or lower
Interested in participating in a cessation program
Have access to a cell phone with unlimited texting ability and have knowledge of text messaging
Patients with documented contraindications for bupropion (bupropion hydrochloride), including: bulimia nervosa, anorexia nervosa; use of monoamine oxidase inhibitors in the past two weeks; documented seizure disorders or predisposition to seizure (ie stroke, brain metastases); abrupt withdrawal from alcohol, benzodiazepines, or other sedatives; closed-angle glaucoma
Poorly controlled intercurrent illnesses
Parents whose child is a pregnant adolescent
Mental impairment leading to inability to cooperate
Agree to consume a standardized vitamin/mineral supplement and avoid other nutrition, dietary or alternative medications/supplements for the duration of the study
Have an active metabolic or digestive illness that impact phytochemical absorption and metabolism, including: diabetes, malabsorptive disorders (Crohn’s disease, documented celiac disease, etc.), renal insufficiency (creatinine [Cr] > 1.4), hepatic insufficiency (nonalcoholic steatohepatitis [NASH], cirrhosis, active viral hepatitis), hyper- or hypothyroidism, or short bowel syndrome
Have had any active oral lesions in the past month or currently have any oral disease or obvious open sores in the oral cavity or surrounding the oral opening
Self-reported average consumption of > 14 alcoholic drink per week
Known diagnosis of familial adenomatous polyposis (FAP) or hereditary non-polyposis colorectal cancer (HNPCC, Lynch syndrome)
Active genital ulcers
Full-time New York City cab drivers
Driving schedule does not include overnight shifts, nor does driver have an additional job overnight
Own a smart phone (in order to collect heart rate variability data)
Have working cigarette lighter receptacle/socket inside taxi cab
With prosthetic heart valves
Self-identified African American
Participants must have either sputum cytologic atypia of mild dysplasia or greater or a history of bronchial biopsy with mild or greater dysplasia within the past 12 months
PILOT II (FAMILY MEMBER): Female and male biological and non-biological family members of BRCA-positive individuals OR Lynch syndrome positive individuals
PILOT III: Less than 2 days of 15 minutes or more of resistance training per week
PILOTS I, II AND III: Unable to walk without crutches, walker, cane, or other assistive device
PILOTS I, II AND III: Women who are pregnant (by self-report)
If continuing in the Control Group portion, agree to not consume fish oil during the duration of the study
Known plans to relocate or move from the Pittsburgh area within the coming 6 months;
Smoking 5 or more cigarettes, little cigars or cigarillos per day, on average, within the 2 months preceding the screening visit and expired carbon monoxide (CO) greater than or equal to 6 parts per million (ppm) (if =< 5, then NicAlert strip > 2)
Individuals rated as moderate (9-16) to high (17 or greater) on suicidality as assessed by module B of the MINI
Positive toxicology screen for any of the following drugs: cocaine, opiates, methadone, benzodiazepines, barbiturates, amphetamines, methamphetamines, phencyclidine (PCP), or delta-9-tetrahydrocannabinol (THC); A: participants with valid prescriptions for opiates, benzodiazepines, barbiturates, amphetamines or methadone will not be excluded; B: participants failing the toxicology screen will be allowed to re-screen once; if they test positive again, they will not be allowed to return
Unwilling to change hairstyle or remove a wig as necessary for the appointment to accommodate the net that is required to be worn on the scalp during the study procedure
In addition, they should also have a cell phone with texting capabilities, read and speak English, reside in close proximity to, or can access the Navy Yard stop on the green line, can provide meaningful consent, and medical clearance from a physician or nurse practitioner
Premenopausal
Baseline mammographic density > 10% based upon the classification system (2 = 11-50%, \scattered fibroglandular densities\; 3 = 51-75%, heterogeneously dense; 4 = >75%, extremely dense). Women with a baseline mammographic density of ? 10% (1 = ?10%, breasts are almost entirely fat) will not be eligible
Mammograms that are reported as suspicious.
Approval for the use of this treatment protocol by the individual institution’s Human Rights Committee must be obtained, in accordance with the institutional assurance policies of the U.S. Department of Health and Human Services
Willing to be followed-up for 6 months
Self identifies as American Indian or Alaska native
Planning to leave the college within next 6 months
CSP-based postgrafting immunosuppression
Patients who are immunocompetent
Patients with a history of severe allergy including eczema or other exfoliative skin disorder or active skin diseases such as psoriasis, lichen planus, severe acneiform rash, impetigo, varicella zoster, or sepsis among patients or among close social, sexual or domestic contacts; patients with burns or other traumatic or pruritic skin conditions or open wounds should not receive the vaccine until the condition has resolved; surgical scars must be healed
Patients with active eczema during the last 12 months
Patients who are in close social/domestic contact with a pregnant woman
Fair, good or excellent cosmesis, as determined by trained nurse assessment using the Harvard Cosmetic Scale
Physiological Model for End-Stage Liver Disease (MELD) >= 30 at screening visit\r\n* If the patient has been dialyzed at least twice within the last 7 days, then the factor used for serum creatinine should be 4.0; any value less than one is given a value of 1 (i.e., if bilirubin is 0.8 a value of 1.0 is used) to prevent the occurrence of scores below 0 (because any positive value below 1 the natural logarithm would yield a negative result); the upper limit of serum creatinine is capped at 4.0; the lower limit of serum sodium (Na) is capped at 125, and the upper limit is capped at 137; after enrollment, if a patient’s MELD increases to 30 or greater, they can still be eligible
At study infusion has a diagnosis of CDI confirmed by a diagnostic assay which detects the presence of C. difficile toxin in stool, and is still receiving antibacterial drug treatment for CDI.
Estimated probability of surviving less than 3 months
Self-identified foreign born individuals in China, Korea, and Vietnam
Not a resident in the Baltimore Washington Metropolitan area
Patients must have started on anastrozole and plan to continue on anastrozole therapy for a minimum of 12 months
Hair that covers the scalp and is at least 1/4 inch in length
scalp metastases or scalp wounds
Subjects should have no serious physical activity, diet, or nutrition restrictions that could interfere with changes brought about as a result of the intervention; restrictions that will be screened for are untreated exercise-induced asthma, orthopedic or neurological problems, and medical conditions affecting nutritional status, intestinal absorption, or response to nutritional intervention (e.g. inflammatory bowel disease)
Serious mental illness or developmental disabilities; subjects should be free of serious mental illness or developmental disability that would limit participation, including eating disorders
Have no significant co-morbidity that precludes participation (i.e. acute, life-threatening illness, communication barriers such as a tracheal tube placement, or altered mental status such as dementia)
Be a permanent resident of the state of Kansas or Missouri
Has been admitted to the hospital greater than three days
Encephalopathy absent
HSCT recipients who underwent ex vivo T-cell depletion of the graft, or a mismatched, or cord or haplo identical blood transplantation
Premenopausal
Extreme orthopedic or mobility issues (e.g., unable to get in and out of a chair unassisted)
Hyperplastic polyp or/and adenoma cases
Polyps free participants with any of the following high risk of colorectal polyps or cancer: (1) family history of colorectal cancer or polyps; (2) current cigarette smoker; (3) obesity (body mass index [BMI] >= 30 kg/m^2); (4) low intake of fiber (lowest fiber intake quartile: daily intake < 16.6 g); (5) high intake of red meat and well-done or processed meat (mutagenicity index >= 5852)
Will live in Nashville or surrounding area for the next 6 months
Current use of blood anticoagulant drugs such as dicumarol (Warfarin), clopidogrel (Plavix), prasugrel hydrochloride (HCl) (Effient), ticlopidine (Ticlid), Lovenox (Enoxaparin), Fragmin (Dalteparin), Innohep (Tinzaparin), eptifibatide (Integrilin), tirofiban (Aggrastat), and abciximab (ReoPro)
Current use of lithium carbonate therapy (Eskalith, Lithobid, Lithonate, Lithotabs, Apo-Lithium carbonate, Apo-Lithium carbonate SR, Carbolith, Duralith, PMS-Lithium carbonate, PMS-Lithium citrate)
Subjects must have an Internet connection and be able and willing to use an applicable device\r\n* If patients do not have an applicable device, they must be willing to borrow an iPad from the study team (to be returned at the conclusion of the study)
Self-identifies as gay or bisexual
Lives in the United States (US)
Participants with oral leukoplakia or erythroplakia with mild, moderate, or severe histologic dysplasia, or hyperplasia not associated with mechanical factors such as ill-fitted dentures
Mothers/female guardians of elementary aged students
Self identify as Latina
Not a parent of elementary aged student in Duarte Unified School District (DUSD)
Does not self-identify as Latina
Consumes 5+ servings of fruits and vegetables and is active for at least 30 minutes 5+ days per week
Willing to avoid exposing breast skin to natural or artificial sunlight (i.e. tanning beds) for the duration of study agent dosing
Women receiving a “nipple delay” procedure prior to mastectomy
Expired-air carbon monoxide (CO) > 8 parts per million (ppm)
Have ever used varenicline
Individuals who are status post total proctocolectomy (i.e. removal of all colon and rectum)
Individuals taking the drugs listed below may not be randomized unless they are willing to stop the medications (and possibly change to alternative non-excluded medications to treat the same conditions) no less than 7 days prior to starting naproxen or placebo on this study; consultation with the participant’s primary care provider may be obtained but is not required; the use of the following drugs or drug classes is prohibited during naproxen/placebo treatment:\r\n* Investigational agents\r\n* NSAIDs: such as aspirin, ketorolac and others NSAIDs\r\n* COX-2 inhibitors: such as celecoxib, rofecoxib and other COX-2\r\n* Antiplatelet agents: such as aspirin, clopidogrel, ticlopidine, dipyridamole, abciximab, tirofiban, eptifibatide and prasugrel\r\n* Anticoagulants:\r\n** Heparin\r\n** Heparinoids: such as fondaparinux, danaparoid and other heparinoids\r\n** Low-molecular weight heparins: such as enoxaparin, dalteparin, parnaparin, reviparin, tinzaparin, ardeparin, certoparin, lepirudin, bivalirudin\r\n** Other anticoagulants: argatroban, apixaban, dabigatran, rivaroxaban, warfarin, acenocoumarol, dicumarol, phenindione and other anticoagulants\r\n* Lithium\r\n* Selective serotonin and norepinephrine reuptake inhibitors: milnacipran, fluoxetine, paroxetine, nefazodone, citalopram, clovoxamine, escitalopram, flesinoxan, femoxetine, duloxetine, venlafaxine, vilazodone, sibutramine, desvenlafaxine\r\n* Anticonvulsants: phenytoin, paraldehyde, valproic acid, carbamazepine, trimethadione, phenobarbital, diazepam, chlormethiazole, mephenytoin, ethotoin, paramethadione, phenacemide, mephobarbital, oxcarbazepine, zonisamide, piracetam, vigabatrin, felbamate, gabapentin, beclamide, fosphenytoin, stiripentol, tiagabine, topiramate, pregabalin, lacosamide, rufinamide, caramiphen\r\n* Antibiotics and antifungals:\r\n** Fluoroquinolones : such as ofloxacin, norfloxacin, levofloxacin\r\n* Other agents: teriflunomide, cyclosporine, tacrolimus, ginkgo, gossypol, meadowsweet, feverfew, beta glucan, pentosan, pentoxifylline, cilostazol, erlotinib, pemetrexed, methotrexate, pralatrexate
Gastric paresis
Celiac sprue
Metal medical implantable device or other MRI incompatible materials
The subject agrees to stop consuming tea or tea-containing products and quercetin supplements throughout the entire intervention period except for the green tea extract and quercetin provided during study intervention
Prior sensitivity or allergic reaction to tea, tea products or tea and quercetin supplements
FOCUS GROUPS AND SURVEYS: Healthy volunteers currently living in San Diego, Portland, Albuquerque, Oklahoma, San Francisco/Bay Area, Nashville, Tucson, Los Angeles, New York City, Minneapolis or Duluth, Minnesota (MN) who attend bars or nightclubs; both current (past 30 day) smokers and nonsmokers will be included in the focus groups and surveys
QUALITATIVE INTERVIEWS WITH KEY INFORMANTS FROM SOCIAL BRANDING CAMPAIGN: Participants are key informants from the Social Branding bar intervention (i.e. facilitators, brand managers, or cessation counselors) who may be young adults or slightly older
Not living in San Diego, Portland, Albuquerque, Oklahoma, San Francisco/Bay Area, Nashville, Tucson, Los Angeles, New York City, Minneapolis or Duluth MN or currently attending college outside of the target cities
50% or higher estimated mammographic density on visual inspection
Timing of follicular phase of menstrual cycle:\r\n* For women who are actively menstruating, at least 4 menstrual periods in past 12 months such that there is a reasonable expectation of being able to perform the aspiration in the follicular phase of the cycle (sometime between day 1 and day 10 inclusive, with day one being the first day of bleeding); very light periods and spotting count OR\r\n* Women who have not had 4 menstrual periods in the past year due to Mirena type intrauterine devices (IUDs) or endometrial ablation may be screened, but hormone levels must be assayed 2-4 weeks prior to RPFNA in order to predict when to perform RPFNA so as to be in the follicular phase; lab results and institutional normal ranges must be reviewed by the protocol chair, who will provide an acceptable time window within which to conduct the RPFNA; women who have had their uterus removed, but still have at least one functioning ovary may be screened using the same hormone level check; must be willing to have same assessment of hormones and prediction of follicular phase repeated for the off-study RPFNA
Considered to be perimenopausal and/or entering the menopause transition
Consumption of systemic antibiotics or commercial supplements containing SDG (e.g. flaxseed or sesame seed supplements) during the 3 weeks prior to baseline RPFNA; consumption of foods containing flaxseed or sesame seed are permitted
RPFNA specimen exhibits hyperplasia +/- atypia; Masood score of >= 13 with >= 500 cells on the cytology slide
Willing to have blood drawn at baseline and 12 months; if non-menstruating, an additional draw will be performed at approximately 11 months so as to predict when to perform the RPFNA
Participants must be willing to abstain from drinking green tea or taking supplements containing green tea or green tea compounds, for the duration of the investigation and for 30 days prior to study entry\r\n* (Please note that patients with a treated T1N0 or T2N0 squamous carcinoma and who do not have a pre-malignant measurable lesion at the time of study entry will not be subjected to a biopsy but will have cytobrush samples taken as specified in the protocol)
Consumption of green tea or supplements containing green tea or tea extract within 30 days prior to enrollment
Advanced adenomas are defined as subject with polyps >= 1 cm, tubulovillous adenomas (25-75 percent villous features), villous adenomas (> 75 percent villous), or high-grade dysplasia
Total colectomy
Patients with a colostomy
Able to hold breathe for 10 seconds
It is recommended the lipid profile be drawn fasting >= 8 hrs; serum lipid profile: total cholesterol/high-density lipoprotein (HDL)/low-density lipoprotein (LDL)/triglycerides (LDL levels prior to chemotherapy must be =< 190 mg/dl), within 30 days prior to enrollment\r\n* If labs are drawn non-fasting and LDL levels are >= 190 mg/dl the lipid profile should be repeated fasting to determine eligibility
40 to 75 years of age with diabetes per American College of Cardiology (ACC)/American Heart Association (AHA) ACC/AHA 2013 guidelines
Women who will have at least one fallopian tube removed for risk-reducing reasons (with or without removal of ovar[ries])
Women who are willing to have a Mirena IUD inserted at least 10 days prior to risk-reducing surgery or who already have the Mirena in place
Women using non-hormonal forms of contraception\r\n*(Note: If a copper IUD is being used, the IUD must be removed prior to or at time of Mirena insertion)
Any medical contradiction to use of a Mirena IUD, including:\r\n* Pregnancy (a pregnancy test is required prior to study entry)\r\n* Known uterine anomaly that distorts the shape of the uterine cavity \r\n* Acute pelvic inflammatory disease\r\n* Postpartum endometritis or endometrial infection\r\n* Known or suspected uterine or cervical neoplasia\r\n* Known history or suspected breast cancer or other progestin-sensitive cancer\r\n* Uterine bleeding of unknown etiology\r\n* Untreated acute cervicitis, vaginitis, or other lower genital tract infections\r\n* Acute liver disease or liver tumor (benign or malignant)
Adequate visualization of entire cervix, cervical lesion(s) and squamous-columnar junction
The standard criteria for prospective clinical trials of medications developed by Drug-Induced Liver Injury Network (established by The National Institute of Diabetes and Digestive and Kidney Diseases) will be used to assess the laboratory test abnormalities. Normal range for these labs will typically be 5 - 40 IU/L for AST; 7 - 56 IU/L for ALT; 0.2 - 1.2 mg/dL for bilirubin. Subjects will be excluded if values are x 2-x 2.5 the upper limit
Family member of the investigation study staff
Estimated probability of surviving less than 3 months
Positive viral test for HIV-1, HIV-2, HBV, HCV, Treponema pallidum, HTLV 1 (if tested), HTLV-2 (if tested), or WNV (if tested)
Dietary intake of large amounts of curry, turmeric spices or black pepper on a regular basis
Enrolled in a communication program (university student review)
Self-reported Hispanic/Latino ethnicity
Physically able to engage in low-to-moderate PA
Consumption of fewer than 5 servings of fruits and vegetables per day
Bilingual Latina
Latina
Reside in the Dan River region of southern Virginia
Hispanic
Have no plans to move in the next six months
Non-Hispanic
Willing and able to provide stool and blood samples at baseline (week 0), week 4, and week 8
Willing and able to attend a gym 3-5 days a week for 4 weeks between week 5 and week 8
Patients who only have a port are ineligible
Known diagnosis of histologically-confirmed BE with or without dysplasia (as defined by the presence of specialized columnar epithelium anywhere in the tubular esophagus with >= 1 cm of circumferential involvement or non-circumferential involvement of specialized columnar epithelium) requiring radiofrequency ablation
Documentation of complete ablation of BE after radiofrequency ablation on two endoscopic examinations at least 3 months apart (including no evidence of BE on surveillance biopsies) as determined by the pathologist at each site; completion of ablation should have occurred no greater than 36 months prior to randomization
Surveillance biopsies demonstrating residual BE at qualifying exam
Have an address in a rural census tract defined by a Rural-Urban Commuting Areas (RUCA) code of 4-10
Interested in participating in a cessation program
Have general knowledge of text messaging
Reside in a rural location as defined by Rural-Urban Commuting Area (RUCA) Codes, Urban Influence Codes, amount of agricultural income, and/or individual commuting patterns
One individual per household will be permitted to enroll in the study
Willingness to provide contact information including phone number, email address and mailing\r\naddress
Creatinine < 2.0 mg/ld
Prior history of severe reactions to oxaliplatin as characterized by the presence of hemodynamic instability, significant respiratory symptoms or potential airway compromise
Subjects must have a smart phone (newer generation Android or any iPhone) to be able to track their food intake times
Subjects must be willing to restrict food intake to a 10 hour period every day (10 am to 8 pm) and wear a smartwatch on their dominant hand
Presumptive evidence that all adenomatous lesions, including qualifying advanced adenoma, have been completely removed
Diagnosis of nonalcoholic steatohepatitis (NASH) and a NAFLD (nonalcoholic fatty liver disease) activity score (NAS) >= 5; NOTES and EXCEPTIONS: NAS is based on findings from a liver biopsy; participants with NAS of =< 2 are eligible for enrollment; participants with NAS of 3-4 must be discussed with the principal investigator and Division of Cancer Prevention (DCP) before enrollment to consider other risk factors (i.e., obesity, alcohol intake); participants with a prior diagnosis of NASH and no available NAS must be discussed with the principal investigator and DCP before enrollment to considered risk factors (i.e., obesity, alcohol intake)
Antinuclear antibody (ANA) test result excludes overt autoimmune disease; note: test result may be reported in any of the following formats: =< 1:160, negative, or < 1.0
African American
Participants in each component (focus groups, surveys and educational programs) will be 18 years of age and over; these men and women are generally healthy, ambulatory and able to participate in events in their community; no women, men, or children of any ethnic or social background will be excluded from the educational program
EDUCATIONAL INTERVENTION:
Self-identify as African American
Aim 5: Director/leader or program manager/coordinator of organization or organization representative who has been nominated to be interviewed by the organization’s director/leader or manager/coordinator
Any clinical worsening from pre-injectable HMA (HYPOMETHYLATING AGENT) baseline condition, including:
worsening granulocytes should be ? 50% decrease from pre-injectable HMA (HYPOMETHYLATING AGENT) baseline value
worsening platelets should be ? 50% decrease from pre-injectable HMA (HYPOMETHYLATING AGENT) baseline value (untransfused)
thrombopoiesis-stimulating agents ([TSAs]; eg, Romiplostim, Eltrombopag, Interleukin-11)
hydroxyurea
Serum total bilirubin > 1.5 x ULN (upper limit of normal). Higher levels are acceptable if these can be attributed to active red blood cell precursor destruction within the bone marrow (ie, ineffective erythropoiesis). Subjects are excluded if there is evidence of autoimmune hemolytic anemia manifested as a corrected reticulocyte count of > 2% with either a positive Coombs' test or over 50% of indirect bilirubin
Prior exposure to veledimex
Presence of any contra-indication for a neurosurgical procedure
Prior thoracic radiation allowed only if there is minimal to no overlap with the treatment area estimated at the time of consultation, and there is no cumulative esophageal dose that exceeds more than 50% of the maximal acceptable dose tolerance
Patients who do not consent for PK studies to be performed (alternatively: patients who initially consent to be on study but withdraws consent for PK study will be taken off study and replaced)
Any participant must obtain prior approval from insurance to reimburse for oral temozolomide for the duration of the study or agree to self-pay for oral temozolomide or obtain institutional commitment from the study site to provide temozolomide
PSADT > 3 months and < 36 months\r\n* Calculated based at least 2 values that are post-treatment and > 0.2 in the prior 2 years with the first and last PSA separated by at least 3 months\r\n* Use all values in the last 2 years that are post-treatment and > 0.2 to calculate PSADT\r\n* PSADT calculated while NOT on androgen deprivation therapy (ADT)\r\n* If prior ADT use, then documented either A) normal testosterone or B) a testosterone within 50 points of normal and stable (defined as a second testosterone at least 6 weeks later that is equal or lower than the first testosterone) is required before starting to calculate PSADT
Willing to be randomized to a no dietary intervention control group or to a low-carbohydrate diet group
Already consuming a carbohydrate-restricted or vegetarian diet
Patient with intermediate risk, early-stage organ-confined prostate cancer (T1a up to T2b, N0, M0) and voluntarily chooses ExAblate thermal ablation as the non-invasive treatment, who may currently be on watchful waiting or active surveillance and not in need of imminent radical therapy.
In the event that a tumor is in contact with the capsule, the length of the contact should be ? 5 mm, on axial images.
Largest imaging dimension of cancerous finding < 20-mm
No definite evidence of extracapsular extension or seminal invasion by MRI
Lower limb musculoskeletal fixed deformities preventing probe insertion or patient positioning during procedure.
Active UTI
Prostatitis NIH categories I, II and III.
Subject has participated in any other clinical investigation that is likely to confound study results or affect study outcome either at the time of IORT or for 3 months prior to IORT.
Thiazolidinedione agents such as rosiglitazone and pioglitazone are not permitted
cN0 or cN1 disease
Largest single focus of disease > 5 centimeters by either mammogram or MRI or both; Note: measurement of the largest single focus should include any satellite lesions within 1 centimeter of the index lesion
cNX, cN2, or cN3 disease
Abnormal ECGs (ie, QT prolongation - QTc > 480 msec, signs of cardiac enlargement or hypertrophy, bundle branch block, signs of ischemia or necrosis and Wolff Parkinson White patterns)
Have never had acupuncture for xerostomia
Suspected or known closure of salivary gland ducts on either side
For neuroblastoma patients only, a positive MIBG (MIBG not required if subject's neuroblastoma is previously determined to not uptake MIBG), abnormal urinary catecholamine levels, or positive bone marrow biopsy/aspirate.
Pregnant women are excluded from this research; the male partner should use a condom; Note: Patients who would be excluded from the protocol strictly for laboratory abnormalities can be included at the investigator’s discretion after approval by the Center for Cell and Gene Therapy (CCGT) Protocol Review Committee and the Food and Drug Administration (FDA) reviewer
Patients who have received a non-FDA or non-EMA approved anti-EGFR agent or any other non-FDA or non-EMA approved agent as part of concurrent radiotherapy
Subject has a confirmed diagnosis of myelofibrosis, including PMF, post-PV MF, and post-ET MF.
Persistent or worsening disease-related symptoms, including but not limited to fatigue, pruritus, night sweats, early satiety, and other symptoms as determined by a MPN-SAF TSS score of >20 points; AND
Prior exposure to veledimex
Clonal BMPC percentage >=60%
Premenopausal women
Women whose most recent CA125 or transvaginal ultrasound is abnormal; a history of abnormal CA125 or ultrasound is allowed, as long as the most recent testing is normal
Daily DHA consumption =< 200 mg/day in the month prior to screening estimated by an abbreviated DHA food frequency questionnaire
Granulocytes (polymorphs + bands) >= 1.5 x 109/L
No concurrent or planned participation in randomized trials of weight loss or exercise interventions or trials targeting insulin, insulin-like growth factor 1 (IGF-1) or their receptors
Inability to come to Vanderbilt General Clinical Research Center (GCRC) for research procedures
Patients with a preexisting tracheostomy
Inflammatory, metabolic or neuropathic arthropathies
Dermatological disease within the acupuncture area
Clinically apparent bleeding diathesis (meaning bleeding that is spontaneous, excessive, or delayed in onset following tissue injury results from a localized pathologic process or a disorder of the hemostatic process, involving a complex interplay among vascular integrity, platelet number and function, coagulation factors, and fibrinolysis)
Lymphovascular invasion
Self-reported inability to walk at least 2 blocks (at any pace).
Insulin requiring diabetes (telephone directed diet and physical activity changes would be difficult in this population without close coordination with the treating physician). Non-insulin requiring diabetics are eligible for the study.
Is currently taking, or has taken within 48 hours of Treatment Day 1 the following drugs with antiemetic properties: 5-hydroxytryptamine 3 (5-HT3) antagonists (e.g., ondansetron), benzamides (e.g., haloperidol), cyclizine, domperidone, herbal therapies with potential antiemetic properties, olanzapine, phenothiazines (e.g., prochlorpenzine), scopolamine (this is not an exhaustive list)
Is allergic to fosaprepitant, aprepitant (MK-0869), ondansetron, or any other 5-HT3 antagonist
Currently enrolled as a first year Ohio State University (OSU) student on the Columbus campus
Self-identifies as being Hispanic or Latino
LHW: self-identified as Filipino, Hmong, or Korean Americans
LHW: Live in the relevant area and intend to stay there for the next 12 months
Medical problems which may prevent them from attending 2 educational sessions
Motivated to remain abstinent (7 or higher out of 10)
Willing to take Progesterone
Psychotropic medications
Pregnancy complications (Diabetes, Anomaly, Fetal growth restriction, HTN, Hx of >2 miscarriages)
Self report of regular menstrual cycles (female only)
Identify as being of Latino heritage, ethnicity, or ancestry
Diagnosis of substance dependence other than nicotine (screened using DSM IV TR criteria) Diagnostic and Statistical Manual of Mental Disorders, fourth edition
The CVC consists of a 5.0 French size, Bard, dual-lumen, PowerPICC catheter
Patients with an occluded (partially or totally) catheter defined as inability to either withdraw blood or instill 3 cc of fluid without resistance through any catheter lumen
Patients in whom the lock solution application will interfere with routine treatment of the underlying disease
Patients receiving phosphodiesterase type 5 (PDE-5) inhibitors (such as sildenafil, tadalafil, vardenafil)
Patients who have a minocycline-rifampin coated CVC
Non-African-Americans
Have preexisting mucositis from other causes.
BMI ? 85 percentile for age and sex (overweight or obese) OR at risk for obesity (BMI between the 50th and 85th percentile and at least one overweight parent (BMI ? 25 kg/m2)
Comorbidities of obesity that require immediate subspecialist referral
Dietary restrictions substantially limiting compliance or vegetarian or vegan diet
Patient has been assessed by treating physician to be appropriate candidate for everolimus plus exemestane therapy as treatment of advanced or metastatic breast cancer and plans to prescribe everolimus 10mg PO QD in combination with exemestane 25mg PO QD
Legal lower age limitations (country specific) Indication for therapeutic-dosed anticoagulants Indication for antiplatelet therapy or a conventional non-steroid anti-inflammatory drug (NSAID) Hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk Calculated creatinine clearance < 30 mL/min
Irritable bowel syndrome, chronic constipation, functional bowel disorders, or colonic motility disorder
Sigmoidoscopy finding requiring clinical intervention
Willingness to consume meals/snacks provided for 28 consecutive days
Drink less than or equal to one alcoholic drink/day
Non-Hispanic African American or non-Hispanic White
Have no evidence of alopecia or mild alopecia (NCI CTCAE grade 1 alopecia defined as hair loss of <50% of normal for that individual that is not obvious from a distance but only on close inspection; a different hair style may be required to cover the hair loss but it does not require a wig or hair piece to camouflage). Female/male-pattern baldness or age-related hair loss are allowed if not greater than grade 1, per NCI-CTCAE v. 4.0. Subjects that have previously lost their hair may enroll if they currently have Grade 0 or 1 alopecia
Patients that indicate they have significant hair breakage or hair damage and associated hair loss from hair over-processing within the last 30 days due to peroxide applications, permanent hair coloring, bleaches, streaking, perms, relaxers and/or hair oxidative dyes.
acute infection without septic shock,
acute ischemic stroke with lower extremity hemiparesis or hemi paralysis
Subjects must agree to abstain from dietary sources of glucosinolates and isothiocyanates beginning three days prior to study and throughout duration of the active study (28 days); participants will be asked to keep a food diary; patients will be asked to record instances of accidental ingestion of these foods, with patients being removed from the study if this occurs 7 or more times
Chlorine (Cl) within 2 x ULN
Carbon dioxide (CO2) within 2 x ULN
able to eat at least soft solids
able to perform oral rinse
Normal anal cytological result, low-grade intraepithelial lesions (LSIL)/condyloma or atypical squamous cells of undetermined significance (ASCUS) result within 90 days prior to entry, and no by high-grade anal intraepithelial neoplasia (HGAIN) on biopsy
Anal cytological result of HSIL, atypical squamous cells suggestive of HSIL (ASC-H), or suggestive of invasive carcinoma at screening; or history of these results
HGAIN (e.g., anal intraepithelial neoplasia [AIN] 2 or 3, or perianal intraepithelial neoplasia grade 2 or 3) or invasive carcinoma at pre-entry on biopsy, or participant has a history of invasive carcinoma or any prior anal cytology result of HSIL or ASC-H
Expected use of any systemic antineoplastic or immunomodulatory treatment, systemic corticosteroids used for greater than 14 days, investigational vaccines, interleukins, interferons, growth factors, or IVIG during study followup; hepatitis C co-infected subjects should not enroll in this study if they expect to initiate treatment for hepatitis C (e.g., interferons) during this trial
Must have pathologically confirmed squamous metaplasia or squamous dysplasia documented by autofluorescence bronchoscopy within the preceding 60 months
Oral ketoconazole or other azole antifungals
uncontrolled dysrhythmias causing hemodynamic compromise,
pericarditis,
dissecting aneurism,
Hyperparathyroidism (parathyroid hormone [PTH] > 80 pg/mL)
Has moderate to severe depression according to Quick Inventory of Depressive Symptomatology-Self Rated 16 (QIDS-SR-16) scores of >= 11 AND a Hospital Anxiety and Depression Scale (HADS) Depression subscale score of >= 8
Korean American immigrant women
Residence in Minnesota
Possession of mobile phone with text-message function
Possession of active email account
Eligible for BCT based on clinical examination, mammography and, if standard practice at a given institution, ultrasound and/or tomogram; women who cannot be appropriately selected for BCT based on these standard imaging studies, and for whom additional imaging is recommended to clarify local disease extent, will not be eligible for this trial; for patients who have neoadjuvant therapy, eligibility for BCT is determined at completion of therapy; repeat mammogram +/- ultrasound (US) will be required at completion of neoadjuvant chemotherapy to determine eligibility for BCT
No patients with multicentric or multifocal disease scheduled to undergo multiple lumpectomies; multifocal disease that can be encompassed in a single operative bed can be enrolled; for patients with multifocal or multicentric disease enrolled after completion of neoadjuvant chemotherapy, histologic confirmation of multifocality/multicentricity must have been completed before initiation of chemotherapy
For patients with intratumoral hemorrhage (acute, subacute, or chronic) seen on hemosiderin-sensitive (gradient-echo) MRI, there must be at least 10 x 10 x 10 mm \measurable enhancement\ that is not obscured or distorted by magnetic susceptibility blooming artifact
Pathologic nipple discharge associated with IPWA (spontaneous bloody or clear persistent single duct discharge)
Sufficient leukemia or MDS specimen available for profiling from diagnosis or recurrence OR bone marrow aspirate or blood draw planned for clinical care anticipated to allow collection of minimum specimen for testing; OR clinical tumor profiling using rapid heme panel available in the medical record
Insufficient leukemia or MDS specimen available for profiling from diagnosis or recurrence; or bone marrow evaluations NOT planned for clinical care; or peripheral blast percentage < 20% AND clinical blood draw not planned; or patient sample did NOT already complete rapid heme panel leukemia profiling clinically
The patient is participating in the trial at an institution which has agreed to perform the imaging research studies, completed the ECOG-American College of Radiology Imaging Network (ACRIN) defined scanner qualification procedures and received ECOG-ACRIN (or current ACRIN) approval
Patient has already had molecular profiling and patient has not yet started matched targeted therapy based on the report; approved molecular profiling include: \r\n* Foundation Medicine FoundationOne\r\n* University of California, San Francisco (UCSF) 500 Cancer Gene Panel\r\n* University of Washington OncoPlex Cancer Gene Panel\r\n* Children's Hospital of Philadelphia (CHOP) Comprehensive Solid Tumor Next Generation Sequencing (NGS) Panel\r\n* Other pre-approved molecular profiling test by study principal investigator (PI)
The patient is participating in the trial at an institution which has agreed to perform the imaging research studies, completed the ECOG-American College of Radiology Imaging Network (ACRIN) defined scanner qualification procedures and received ECOG-ACRIN approval as outlined
Capable of making informed decisions regarding his/her treatment
Patients of all ethnicities will be included
Patients with a metallic hip implant, metallic implant or device in the pelvis or ferromagnetic fiducial beacons (Calypso) that might distort local magnetic field and compromise quality of MP-MRI
Patients with a metallic hip implant or any other metallic implant or device in the pelvis that might distort local magnetic field and compromise quality of MRI
Cancer located on a site that may not be convenient or accessible for imaging with the current version of the RCM device (gingivobuccal region, back of the oral cavity, back of the tongue, floor of the mouth, deep under the tongue, etc.)
Surgical staging with retroperitoneal staging and lymphadenectomy is permitted
CHILDREN
CHILDREN
For cohort C, patients with GBM who have completed standard temozolomide + radiation and have suspected pseudoprogression can enroll; there is no time frame from completion of chemoradiation as pseudoprogression is increasingly recognized at later time points
High or mixed affinity binders (alanine [Ala]/Ala or Ala/threonine [Thr]) based on genotyping result from PBR affinity test; this blood test will be performed as part of the screening process after consent has been obtained
The patient’s 4DCT-ventilation image meets the heterogeneity criteria
Patients with suspected or histologically documented new non-small cell carcinoma that have agreed to undergo a thoracotomy for segmentectomy, lobectomy, bilobectomy or pneumonectomy as recommended by their thoracic surgeon for treatment
There is a predetermined plan to pursue stereotactic body radiation therapy (SBRT) in the event of a nondiagnostic study procedure in patients with a nodule within SPiNPerc range (i.e. The patient would not go on for a CT guided TTNA), OR There is a predetermined plan to pursue stereotactic body radiation therapy (SBRT) in the event of a nondiagnostic study procedure in patients where the target nodule is within a region considered to be not accessible to a percutaneous approach as determined by the radiology core lab and thus would prevent a confirmatory tissue diagnosis before SBRT.
Participants must have a pre-operative standard mammogram with or without ultrasound; these may be performed at outside institutions but must be reviewed at Brigham and Women's Hospital/Dana-Farber Cancer Institute (BWH/DFCI)
Able to produce 45mL of urine
Ability to remain motionless in MRI scanner for approximately 40 minutes
Subjects with clinically significant signs of uncal herniation, such as acute pupillary enlargement, rapidly developing motor changes (over hours), or rapidly decreasing level of consciousness, are not eligible
Presence of biliary-enteric anastomosis
Very young children who need sedation or anesthesia will be excluded from the study; there will be no gender or race-ethnic restrictions
Need of sedation or
Hemosiderosis/hemochromatosis
Patients of all ethnic and gender groups will be included; protocol accrual will be reviewed annually to include a determination of minority and gender representation; if accrual demonstrates under-representation of any group with comparison to disease incidence in that group, appropriate measures will be undertaken to increase participation of patients of that minority or gender group
Patients considered in “vulnerable” populations
Symptomatic osteonecrosis (ON) of the femur or proximal tibia with MR signal abnormalities that involve more than 50% of the respective joint surface, but no evidence of epiphyseal collapse
Hemosiderosis/hemochromatosis (patients can still be included in the 2nd branch without receiving ferumoxytol)
Individuals with plasma creatinine > 180 umol/L
Patients undergoing :\r\n* Surgical laryngeal, esophageal, and tracheal endoscopy (“panendoscopy”)\r\n* Fiberoptic esophagoscopy\r\n* Intubation\r\n* Office-based nasal or laryngeal endoscopy
Patients who have implantable devices that are contraindicated for MRI
Patients with minimal FDG-avidity localized to the planned treatment target (e.g. maximum standardized uptake value [SUV] < 4.0)
Patients who are claustrophobic
Presence of erosive esophagitis
Patients not interested in pursuing surgical intervention for their disease (i.e. refusing treatment or requesting radiation oncology referral)
Known Paget’s disease
Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam
For patients highly suspected to have aGVHD and requiring systemic therapy, informed consent should be signed after biopsy taken to support clinical diagnosis.
Be capable of understanding the investigational nature of the study and all pertinent aspects of the study
Have metallic hardware in the lower extremity which is MR compatible however would create too much artifact for MR examination
Are unable to lay still in the MR scanner for length of examination
Contraindication to furosemide administration including prior allergy or adverse reaction to furosemide or sulfa drugs; (Note: This exclusion criteria can be removed if furosemide is omitted as part of the PET imaging protocol if a second-generation scatter correction is available for the used PET device)
Planned administration of any NET therapy between scan 1 and 2, except for short acting octreotide
HEALTHY CONTROLS: Women with no suspected gynecological cancer
Patients with known or suspected right-to-left, bi-directional, or transient right-to-left cardiac shunts
Patients with a history of anaphylactic allergy to Definity, manifested by one or more of the following symptoms: generalized urticaria, difficulty in breathing, swelling of the mouth and throat, hypotension, or shock
Patients with congenital heart defects
Subjects who lack fitness for flexible bronchoscopy as determined by the physician performing the bronchoscopy before the procedure
Subjects must have neurological findings (i.e. loss of consciousness, paresis, cranial neuropathy, etc.), and/or radiological abnormalities in the brain (neoplastic or non-neoplastic in nature)
Subjects with clinically significant signs of uncal herniation, such as acute pupillary enlargement, rapidly developing motor changes (over hours), or rapidly decreasing level of consciousness, are not eligible
Referred to the Washington University School of Medicine for conditions necessitating surgery to include at least a unilateral oophorectomy
Subjects with clinically significant signs of uncal herniation, such as acute pupillary enlargement, rapidly developing motor changes (over hours), or rapidly decreasing level of consciousness, are not eligible
Pathologically confirmed, well differentiated functioning or non-functioning metastatic GEP-NET (Grade I and II as per World Health Organisation classification 2010)
Subject who have received treatment of any somatostatin analogue, including Somatuline® Autogel® /Depot®, Sandostatin® LAR within 28 days, and Sandostatin® within 24 hours prior to first 68Ga-OPS202 administration
Patients requiring conscious sedation for imaging
Radioiodine (RAI)-refractory and/or metastatic disease on structural imaging (CT, MRI) with RAS or RET mutations or BRAF-wild type thyroid cancer
Patients must have confirmation of prostate cancer with identifiable metastatic disease on at least 1 clinically indicated imaging modality; if there is only soft tissue metastasis, one lesion must measure at least 6 mm or greater
Localized SCCHN.
For patients with reproductive potential must undergo counseling to understand unknown risks to resultant progeny.
Minors will be excluded
Prisoners and members of other vulnerable populations will be excluded from this study as these populations will not provide any additional unique information or uniquely benefit from the study
Be willing to allow for investigators to collect archival tumor tissues from surgical procedures that may have been performed before or after enrollment into this trial for research purposes (in-house cases and/or outside cases). These samples will be obtained by study staff as long as subject continues on follow-up. Blocks of tissue will be requested, and if blocks are not able to be obtained, 5 micron slides (10-15) will be sufficient
Be willing to be injected with 11C-methyl-L-tryptophan (C11-AMT)
Currently using nicotine replacement or other tobacco cessation products or intentionally abstaining from nicotine-containing products
Brain MR imaging suggestive of a glioma or 2HG > 2 mM by MR spectroscopy in patients who have not had a surgical procedure to establish the diagnosis
Deep positive margin
Patients with hypersensitivity to egg or egg products, because sonazoid contains a chicken egg-derived surfactant (hydrogenated egg phosphatidylserine sodium)
Risk of poor cosmetic outcome after initial lumpectomy and possible additional excision, as assessed by Dr. Sharma
Recommendation for mastectomy based on radiology
Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam
PART B ONLY
Metallic implant or device that distorts local magnetic field and compromises the quality of MR imaging
Metallic hip implant or any other metallic implant or device that distorts local magnetic field and compromises the quality of MR imaging
Children
Highly suspicious pulmonary nodule(s), defined as distinct nodule with a diameter of ?8mm in its largest dimension
Severe emphysema or COPD: additional testing and PI consent is required
Registered with the clinical trials office of the Karmanos Cancer Center/Wayne State University
Active prostatitis
Image quality acceptable for comparison with later MRI as read by a neuroradiologist
Patients, whose MRI at post operative 48-72 hours are not readable due to artifacts or disease process shall not be included in the study
pT3 (seminal vesicle invasion or extraprostatic extension), or
Patients presenting with a pituitary nodule presumed to be resectable on pre-operative assessment
Patients with significant neurological motor deficits of the upper extremities, which would preclude them from performing the while awake intra-operative tasks
Patient will have suspicion of recurrent prostate carcinoma as defined by: older American Society for Radiation Oncology (ASTRO) criteria of three consecutive rises of PSA or earlier if clinically appropriate, and/or nadir + 2.0 ng/ml (ASTRO-Radiation Therapy Oncology Group [RTOG] Phoenix criteria)
Individuals who are considered to be mentally disabled will not be recruited for this study
Individuals who are considered to be mentally disabled will not be recruited for this study
Women, children, fetuses, neonates, or prisoners are not included in this research study
Inability to lay flat for at least 2 consecutive hours
Have engaged in occupations or activities which may cause accidental lodging of ferromagnetic materials (e.g. iron), or have embedded metal fragments from military activities
Have received orthodontic work involving ferromagnetic materials
Claustrophobic (i.e. feeling very anxious in a confined small space)
Obesity that limits obtainment of acceptable images
Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam
HEALTHY VOLUNTEER: A history of chest wall trauma or surgery, or dermatologic disorders, which could be expected to disrupt lymphatic drainage of the chest wall
HEALTHY VOLUNTEER: Patients with a history of anaphylactic allergy to eggs or egg products, manifested by one or more of the following symptoms: generalized urticaria, difficulty in breathing, swelling of the mouth and throat, hypotension, or shock
HEALTHY VOLUNTEER: Significant axillary, supraclavicular, or other chest wall palpable adenopathy
PATIENT: Patients with a history of anaphylactic allergy to eggs or egg products, manifested by one or more of the following symptoms: generalized urticaria, difficulty in breathing, swelling of the mouth and throat, hypotension, or shock (subjects with non-anaphylactic allergies to eggs or egg products may be enrolled in the study, but must be watched carefully for 1 hour [h] following the administration of Sonazoid)
Confirmed diagnosis of Erdheim-Chester disease or Langerhans cell histiocytosis or other histiocytic disorder and requiring additional diagnostic imaging and biopsy to determine mutational status in order to determine therapeutic options
Investigator precludes participation for scientific reasons, for reasons of compliance, or for reasons of the patient’s safety
Patients who cannot tolerate or have contra-indications to endorectal coil insertion; for example, patients with a prior abdominoperineal resection of the rectum or latex allergy
Metallic hip implant or any other metallic implant or device that distorts local magnetic field and compromises the quality of MR imaging
Treatment with Sandostatin long-acting release (LAR) within 4 weeks, subcutaneous (SQ) Octreotide within 12 hours, or Lanreotide injection within 8 weeks of Ga-68 DOTATOC PET/CT (+/-5%)
Able to have bronchoscopic placement of Calypso transponders as confirmed on a recent (within the past 8 weeks) CT scan
Able to breathe regularly for gated treatment, as measured with the Varian Real-time Position Management (RPM) system
Bronchiectasis in the region of the intended implantation
Inability or refusal to have at least one peripheral intravenous line for intravenous access (as applicable to the day of [carbon C 13 (1-13 C)] pyruvate injection)
Hemorrhagic cystitis or active prostatitis
Subjects who require sedation for WB MRI will be excluded if they have: \r\n* An acute cardiopulmonary process including, but not limited to, croup, reactive airways disease, pneumonia, clinical or radiological evidence of pericardial effusion or other cardiopulmonary disease\r\n* Vomiting within 24 hours of the MRI or substantial nausea that may preclude sedation as determined by the anesthesiologist or certified registered nurse anesthetist
Both sporadic desmoid tumors and those associated with familial adenomatous polyposis (FAP) syndromes will be included
Any race
Color blindness (cannot complete Delis–Kaplan Executive Function System [D-KEFS] Stroop test)
Moderate or severe depression as measured on the Beck Depression Inventory (BDI) - Short Form; the cut-off score for the BDI will be 8/9
Patients must have tumors that produce CEA as documented by a current or past history of an elevated serum CEA above the institutional limit of normal, or by immunohistochemical methods; NOTE: Patients with colorectal cancer are exempt from this requirement since > 95% are CEA positive
Any woman with a confirmed preoperative diagnosis of cervical AIS, including co-existing squamous cervical intraepithelial neoplasia (CIN) and/or microinvasive cancer
Patients consented for the trial that on the baseline 2-dimensional (2D) study have poor acoustic echo windows (i.e. a reader is unable to see in definition 2 or more segments from the apical views) will not be eligible to continue in the trial and peak hyperemia images will not be obtained
Prisoners and members of other vulnerable populations will be excluded from this study; the subject selection population will not regularly include prisoners and other vulnerable population members as these populations will not provide any additional unique information to or uniquely benefit from the study; non-English speaking population will be excluded from the study
Inflammatory disease (for example fever of unknown origin, vasculitis, osteomyelitis)
3Tesla (T) multiparametric MRI of the prostate performed at City of Hope (COH) within 6 week time period prior to surgery; MRI without evidence of bladder neck involvement, rectal wall involvement, or pelvic lymphadenopathy with no nodes > 1 cm
Unable to undergo an 18F-DOPA PET scan (e.g. Parkinson’s disease, taking anti-dopaminergic, or dopamine agonist medication or less than 6 half-lives from discontinuance of dopamine agonists; NOTE: other potentially interfering drugs: amoxapine, amphetamine, benztropine, buproprion, buspirone, cocaine, mazindol, methamphetamine, methylphenidate, norephedrine, phentermine, phenylpropanolamine, selegiline, paroxetine, citalopram, and sertraline; if a patient is on any of these drugs, list which ones on the on-study form
Ability to hold the breath for 10 seconds
Unable to undergo an 18F-DOPA PET scan (e.g. Parkinson’s disease, taking anti-dopaminergic, or dopamine agonist medication or less than 6 half-lives from discontinuance of dopamine agonists); NOTE: other potentially interfering drugs consist of: amoxapine, amphetamine, benztropine, bupropion, buspirone, cocaine, mazindol, methamphetamine, methylphenidate, norephedrine, phentermine, phenylpropanolamine, selegiline, paroxetine, citalopram, and sertraline; if a patient is on any of these drugs, list which ones on the on-study form
Ventilator
33 consecutive consenting patients presenting to The Ohio State University James Cancer Hospital Otolaryngology Department with a suspicious oral lesion or prior biopsy-confirmed epithelial dysplasia (mild, moderate, severe), carcinoma in situ (CIS), or squamous cell carcinoma (SCC) will be recruited; adult patients presenting for initial evaluation for treatment planning and/or presenting for follow-up appointments monitoring for recurrence will be eligible to participate
Females with tattoos on either or both breasts
Females with nipple piercings on either or both breasts
Females with skin piercings (aka microdermal anchor surface or microdermal piercings) in either or both breasts
Inability or refusal to have at least one peripheral intravenous line for intravenous access (as applicable to the day of [ 18 F] 4-L-Fluoroglutamine (2S,4R) injection and blood draws)
Subjects that may have shrapnel imbedded in their bodies, such as from war wounds, metal workers and machinists (metallic fragments in or near eyes), severe auto accident victims
Known right to left cardiac shunt, bidirectional or transient
Any patient who will not be returning routinely for follow-up at Massachusetts General Hospital (MGH) or Dana-Farber/ Harvard Cancer Center (DFHCC)
Primary or secondary brain tumor (enhancing mass lesion +/- nonenhancing abnormality), known or suspected, located near (< 2 cm) any portion of the motor cortex, motor pathway, language cortex, or language pathway, or other clinically relevant brain areas, as determined on anatomical images
Less than 5 mm distance to a structure (gastrointestinal [GI] or biliary tract), that cannot be protected from the ablation injury with technical modifications such as hydro or air dissection\r\n* This will not be considered exclusion when IRE is used
INR > 1.5 that cannot be corrected with fresh frozen plasma \r\n* For patients on Coumadin general clinical guidelines for IR ablation will be followed
Known hyperthyroidism
Patients must document their willingness to be followed until death or time of progression; time on study for purposes of adverse event reporting however will be from the time of injection of FMISO to 24 hours after the FMISO injection (completion of drawing of second set of laboratory studies in initial 10 patients); by signing informed consent, the patients are documenting their agreement to have clinical and radiographic endpoints and the results of histopathologic tissue analysis and other laboratory information entered into a research database
Patients who exhibit noticeable anxiety and/or claustrophobia or who exhibit severe vertigo when they are moved into the MR
Possible or suspicious sebaceous gland carcinoma of the eyelid
Patients with clinically significant signs of uncal herniation, such as acute pupillary enlargement, rapidly developing motor changes (over hours), or rapidly decreasing level of consciousness, are not eligible
Inability to understand and/or carry out instructions
Subjects with clinically significant signs of uncal herniation, such as acute pupillary enlargement, rapidly developing motor changes (over hours), or rapidly decreasing level of consciousness
Diseases of the soft or hard oral tissues
Radiographic diagnosis: Patients must have a brain tumor (including, but not limited to high grade gliomas, low-grade gliomas, primitive neuroectodermal tumors, ependymomas) or residual abnormality (e.g. post-operatively or post-radiation) that is measurable or evaluable on standard MRI or computed tomography (CT)
African-American or white men (Hispanic or non-Hispanic)
Have a condition or impediment (i.e., insect bites, poison ivy, open sores, chafing of the skin, scar, tattoos, moles, etc.); that could interfere with the intended field of view (within one probe length or 4 cm of the nodule),
Prisoners and members of other vulnerable populations will be excluded from this study; non-English speaking population will be excluded from the study
Minors will be excluded
Evidence of calcifications on mammogram
Patients with injection of other radioactive material within 90 days
neurostimulator,
have engaged in occupations or received orthodontic work which may have caused lodging of ferromagnetic materials in the body;
are claustrophobic;
are diabetic;
Must have surgically curable disease as evaluated by initial imaging by our UNC surgeons
Presence of pacemaker, intracranial aneurysm clip, bladder stimulator, cochlear implant or metal near eyes or near pelvis that would create excessive imaging artifact
Patients with congenital heart defects.
Refusal to have an IV placed for injection
Subjects with cervical or Siewert 3 esophageal carcinoma, that are recommended by the multi-disciplinary tumor board to have treatment other than tri-modality chemo-radiation therapy (RT) followed by esophagectomy
Has a known hypersensitivity to indocyanine green (ICG), methylene blue and Technetium TC-99m colloid (99mTc-colloid)
Children will be excluded from this study
Neurofibromatosis type 1 (NF1) status will be determined by clinical exam or genetic testing
Patient with right-to-left, bi-direction, or transient right-to-left cardiac shunts
Respiratory failures marked by signs and symptoms of carbon dioxide (CO2) retention or hypoxemia
Off Sandostatin (octreotide acetate)-long acting release (LAR) > 4 weeks and off immediate release (subcutaneous) for 12 hrs prior to 68Ga-DOTATOC PET-CT
No therapy other than Sandostatin since last Octreoscan + diagnostic CT
=< 3 total cores positive
=< 50% of any given core involved with cancer
The MRI and ABUS exam must be obtained in a timely manner after the consult, and the imaging exams will be obtained within 2 weeks of each other
Subjects who lack fitness for flexible bronchoscopy as determined by the physician performing the bronchoscopy before the procedure
Prostrate volume ? 20cc and height at least 22mm (at the area(s) to be biopsied) as verified by ultrasound or prostrate MRI
Minors, pregnant patients, incarcerated individuals, and individuals unable to give informed consent will be excluded from the study
Women presenting for mammographic evaluation of an undiagnosed palpable mass found either by self examination and/or examination by referring physician
Patients with a pure ground-glass opacity identified on chest CT
Lack fitness to undergo flexible bronchoscopy as determined by the bronchoscopist prior to procedure
Presence of a biliary stricture
Inability to cannulate the common bile duct
Presence of altered anatomy (Billroth II or Roux-en-Y reconstruction)
Intrahepatic biliary strictures or strictures within 2 cm of the ampulla
No stricture
Patients with history of histologically-confirmed neoplasm of any of the following classifications: solid malignancy, myeloid neoplasm, lymphoid neoplasm
Inability or refusal to have at least one peripheral intravenous line for intravenous access (as applicable to the day of 18F SKI-249380 injection and blood draws)
Participants with clinically significant signs of uncal herniation, such as acute pupillary enlargement, rapidly developing motor changes (over hours), or rapidly decreasing level of consciousness, are not eligible
Clinically unstable, severely ill, or moribund
Contraindication to furosemide administration including prior allergy or adverse reaction to furosemide or sulfa drugs; (Note: This exclusion criteria can be removed if furosemide is omitted as part of the PET imaging protocol if a second-generation scatter correction is available for the used PET device)
Patients must have their echocardiograms performed such that strain may be calculated using either GE or Tomtec software
Other serious illness (es), which might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study
Off Sandostatin (octreotide acetate)-long acting release (LAR) > 4 weeks and off immediate release (subcutaneous) for at least 12 hours (hrs) prior to 68Ga-DOTATOC PET-CT imaging
Patients must be eligible for breast-conserving therapy (BCT) based on clinical examination and mammography; if ultrasound is performed, findings must also be consistent with eligibility for BCT
Other serious illness(es) which might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study
Patients that may need dose reduction to commence cycle 1 treatment
Patients who are claustrophobic
Patients with a metallic hip implant or any other metallic implant or device in the pelvis that might distort local magnetic field and compromise quality of MRI
Patients unlikely to be optimally debulked at surgery (tumor implants in difficult to reach places [i.e. falciform ligament or porta hepatitis], suprarenal retroperitoneal lymphadenopathy)
Patients who undergo intra-arterial hepatic 99mTc MAA evaluation in anticipation of 90Y microsphere radioembolization
Patients with hip implant or any other metallic implant or device that results in significant distortion of the local magnetic field and compromise of the quality of the multiparametric MRI data
Determination by the surgeon that the neoplasm is non-palpable; a patient with a palpable hematoma from core biopsy, but a non-palpable neoplasm, will be eligible for study
Must be:
Life expectancy >1 year. LGL-Specific:
Histopathologically confirmed mycosis fungoides or Sézary syndrome (CTCL stage IIB or greater according to the European Organization for Research and Treatment of Cancer/International Society for Cutaneous Lymphomas [EORTC-ISCL] consensus classification) at study entry with progressive, persistent, or recurrent disease who have no available remaining standard therapeutic options (i.e., Refractory) as determined by the Investigator.
Prior RT to the same region that would be irradiated in this study
Abnormal c-MET dysregulation, defined as the following from archival historical results of molecular pre-screening evaluations.
Has consumed herbs/fruits that may have an influence on pharmacokinetics (PK) of DS-3201b from 3 days (14 days for St. John's wort) prior to the start of the study and throughout the entire study
Acyclovir resistant mucocutaneous HSV infection based on clinical failure (no improvement after at least 5 days with FDA approved high doses with acyclovir, valacyclovir or famciclovir) requiring switch to foscarnet treatment.
Willingness to abstain from the application of lotions and/or creams to the area with HSV lesions. Wet/dry saline dressings or bandages at lesion site are allowed.
ACV-resistant and foscarnet-resistant/intolerant mucocutaneous HSV infection based on clinical failure (no improvement after at least 5 days of foscarnet therapy or intolerance to foscarnet requiring cessation of foscarnet treatment) or result from genotypic/phenotypic testing.
Exposure to specific substrates of the drug transporters OATP1B1, OATP1B3, MATE1 and MATE2K within the appropriate wash-out period (a minimum of 5 x reported elimination half-life) before the first dose of study treatment
Paraneoplastic syndrome of autoimmune nature, requiring systemic treatment or clinical symptomatology suggesting worsening of PNS
Prior exposure to CBT-1
Sustained platelet count ?50,000/µL, and/or sustained Hgb ?8 g/dL and/or sustained ANC ?1000/mm3, which is considered by the Investigator as related to the nature of the graft (higher transient levels following occasional blood product transfusions are allowed).
Be of nonchildbearing potential:
STEAP1 antigen positive tissue known from prior IHC testing or if STEAP1 status is not known archival sample will be sent to Genentech for IHC; samples needed to be positive, when feasible metastatic lesions will be tested preferentially rather than primary
TREATMENT GROUP: Premenopausal or peri-menopausal, defined by having regular menstrual cycles that are regular but may have > 7 days variability in the length of consecutive cycles (irregularity caused by hormonal contraceptive use is acceptable if the subject is 45 years of age or younger)
NORMAL GROUP: Premenopausal or peri-menopausal, defined by having regular menstrual cycles that are regular but may have > 7 days variability in the length of consecutive cycles (irregularity caused by hormonal contraceptive use is acceptable if the subject is 45 years of age or younger)
Have engaged in occupations or activities which may cause accidental lodging of ferromagnetic materials, or have imbedded metal fragments from military activities
Have received orthodontic work involving ferromagnetic materials
Are claustrophobic
All patients who have gynecologic malignancies involving the middle third and the distal third of the vagina who will be receiving radiation therapy
Any implantable medical device that is not MRI compatible (e.g. pacemakers, defibrillators, pain pumps or insulin pumps)
Patients will be screened with a questionnaire to be sure they have no medical devices that could make the procedure unsafe
Subject weighs more than 400 pounds; (subjects who weigh more than 400 pounds will not be able to fit inside the imaging machines)
Uncontrolled or unstable hyperthyroidism or Grave’s disease
Patients with congenital heart defects
Planned thorascopic, robotic or laparoscopic surgical approach
Unable to comply with breathing or other imaging related instructions resulting in inability to obtain diagnostic quality CT or MRI studies (OPTN Class 0)
Patients must have previously responded to a molecularly-targeted therapy and subsequently developed resistance, or have an analogous clinical situation in which determining their molecular genotype is of interest clinically and/or scientifically
Ureteral stint present or removed within six weeks
GROUP 1: Non-oncologic patients from Veteran Affairs Medical Center (VAMC) in Houston:
Subjects with clinically significant signs of uncal herniation, such as acute pupillary enlargement, rapidly developing motor changes (over hours), or rapidly decreasing level of consciousness, are not eligible
Has the following International Federation of Gynecology and Obstetrics (FIGO) IA2-IIA1staging. Subjects with a single enlarged/suspicious node on PET/CT will still be considered eligible as consistent with FIGO guidelines.
GROUP A (painful neuropathy group): Must have subjective symptoms of painful peripheral neuropathy (burning, stabbing, throbbing, painful tingling, aching in the fingers and/or toes) that is greater than or equal to 10 on a scale of 0 to 100 in the neuropathic pain questionnaire
Diagnosed with mCRPC and painful bone metastases, referred for Xofigo (radium Ra 223 dichloride)
No clinically relevant deviations in renal function (Serum Creatinine > Grade 2 CTCAE v4.0.). Maximal interval between confirmation and injection of 18F-FSPG is one week.
evaluation of 18F-FSPG safety and tolerability will not be confounded by the other investigational PET or SPECT tracer
a minimum of two days (or longer as necessary based on radiological half-life) have elapsed between investigational PET or SPECT tracer administrations to allow acceptable clearance of the tracer
Subjects incapable of giving informed written consent, for the following reasons:\r\n* Inability to adhere to the experimental protocols for any reason\r\n* Inability to communicate with the research team\r\n* Limited ability to give informed consent due to mental disability, altered mental status, confusion, or psychiatric disorders\r\n* Prisoners or other individuals deemed to be susceptible to coercion
Subjects incapable of giving informed written consent, for the following reasons:\r\n* Inability to adhere to the experimental protocols for any reason\r\n* Inability to communicate with the research team\r\n* Mental disability, altered mental status, confusion, or psychiatric disorders\r\n* Prisoners or others susceptible to coercion
Patients who have any type of ferromagnetic bioimplant that could potentially be displaced
Patients who may have shrapnel imbedded in their bodies (such as from war wounds), metal workers and machinists (potential for metallic fragments in or near the eyes)
Patients who exhibit noticeable anxiety and/or claustrophobia or who exhibit severe vertigo when they are moved into the magnet bore
Women with a history of prior loop electrosurgical excision procedure (LEEP) or cone procedures performed on their cervix
Intolerance of hyperoxia or hypercarbia as delivered by the RespirAct™ breathing circuit
Subjects who may have shrapnel imbedded in their bodies (such as from war wounds), metal workers and machinists (potential for metallic fragments in or near the eyes)
Subjects who exhibit noticeable anxiety and/or claustrophobia or who exhibit severe vertigo when they are moved into the magnet bore
Subjects incapable of giving informed written consent, for the following reasons:\r\n* Inability to adhere to the experimental protocols for any reason\r\n* Inability to communicate with the research team\r\n* Limited ability to give informed consent due to mental disability, altered mental status, confusion, or psychiatric disorders\r\n* Prisoners or other individuals deemed to be susceptible to coercion
Note that patients will need to be sufficiently healthy to undergo audiovisual (AV) biofeedback
Children, pregnant women, Stanford employees or students, or prisoners will be excluded from this study
Patients without visible BE at time of study EGD.
Patients must be assessed by surgeons and are considered surgically resectable
Men in whom artifact would reduce the quality of the MRI
Previous hip replacement surgery, metallic hip replacement or extensive pelvic orthopaedic metal work
Primary tumor of any T-stage within or touching the zone of the proximal bronchial tree, defined as a volume 2 cm in all directions around the proximal bronchial tree (carina, right and left main bronchi, right and left upper lobe bronchi, bronchus intermedius, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi)
Prior diagnosis of cancer treatment induced left ventricular dysfunction (CILVD) with recovered LVEF (i.e. improved to > 50%) for at least 6 months with recommended HF medications (ACE-I or ARB and/or beta [B]-blocker)
Absence of other causes of cardiomyopathy (e.g. ischemia, hypertension, amyloidosis, or hemochromatosis) per chart review of the clinician’s documentation
Residence within the United States
Exhibiting HF symptoms (e.g. shortness of breath, edema)
Hemosiderosis/hemochromatosis
Patients with congenital heart defects
Prior SLN dissection
Heart rate < 60 prior to propranolol
Referred to University Hospitals Case Medical Center (UHCMC) Nuclear Medicine for methylene diphosphonate (MDP) bone scintigraphy
For salvage setting patients, lack of documented treatment or management recommendation on file
Patients with (any one of the following):\r\n* Suspicion of NET on axial imaging (CT/magnetic resonance imaging [MRI]/fludeoxyglucose [FDG] PET) and/or\r\n* Biochemical evidence of neuroendocrine tumor (serum/urinary) based on elevated levels of chromogranin A, pancreatic polypeptide, neuron-specific enolase, vasoactive intestinal polypeptide, serotonin (urinary 5-hydroxyindoleacetic acid [HIAA]), gastrin, somatostatin, catecholamines, metanephrines, calcitonin, fasting insulin, C-peptide (proinsulin), glucagon and/or\r\n* Familial predisposition to NET in patients with multiple endocrine neoplasia type 1 (MEN1) and Von Hippel-Lindau (VHL) (symptomatic and/or asymptomatic cases; with biochemical or anatomic imaging evidence of disease)
Asymptomatic women
Women with symptoms such as palpable mass or nipple discharge
Patients must be able to perform ABC procedures
No vulnerable populations will be enrolled (prisoners, children, pregnant females or institutionalized individuals)
Patients imaged for Cerenkov luminescence are going to be required to be in a darkened enclosure for at least 10 minutes and sit still during image acquisition, potentially covered by a dark cloth in case that the ambient light level remains too high for the ultra-sensitive camera; any conditions that would prevent this will exclude the patients
Right-hand dominance
At least one lesion that can be accurately measured in two dimensions utilizing mammogram, ultrasound, or MRI images to define specific size and validate complete pathologic response.
Patient has contraindication to either endobronchial ultrasound or mediastinoscopy such as: history of bleeding diathesis, latex allergy, mediastinoscopy, mediastinal nodal resection, tracheostomy
An intact cervix.
Patient who presents to clinic with a history of hoarseness and voice changes and are noted to have changes to their vocal folds that are concerning for the possibility of dysplasia or early stage malignancy
Require more than one localization needle for localization of the surgical target (bracket localization)
Any condition that would alter the patient’s mental status, prohibiting the basic understanding and/or authorization of informed consent
Extremely poor intravenous access, prohibiting the placement of a peripheral IV line for injection of radiotracer
Cohort B and Expansion: Screening visit peripheral blood must be submitted for central analysis at a sponsor-designated laboratory to identify spliceosome hotspot mutations in SF3B1, SRSF2, U2AF1, mutations in ZRSR2, and SRSF2 deletion including amino acid P95.
Corrected vision is worse than 20/40 unless due to cataracts.
Current evidence of corneal disorder/keratopathy including but not limited to bullous/band keratopathy, corneal abrasion, inflammation/ulceration, or keratoconjunctivitis
Active infection, with the exception of resolving cholangitis, will preclude enrollment on the study; preoperative interventions can only be initiated when acute cholangitis has resolved*
Any chronic medical condition requiring daily corticosteroids or other immunosuppressants (e.g. tacrolimus, sirolimus, cyclosporine, azathioprine, mycophenolate mofetil, etc.)
Castration-resistant PCa
Self-identify as African American or Black
Willing to abstain from cruciferous vegetable consumption other than the study vegetables during the study period
Vegetarians
Patients with indications that limit or extend initial surgery, including need for lymphadenopathy, recurrent laryngeal nerve (RLN) dysfunction, and concurrent primary hyperparathyroidism will be excluded.
Have a confirmed diagnosis of type I endometrial cancer (endometrioid) based on pre-operative endometrial biopsy or dilation and curettage (D&C)
Healthy adults who reside within the greater Twin Cities area
No international travel planned during the next 4 months
Maintain a consistent general diet without significant variation
On prophylactic antibiotics, such as trimethoprim-sulfamethoxazole for pneumocystis prophylaxis or post-transplant penicillin prophylaxis
Patients who have too much esterase as determined by a pre-screen dose, with a conversion rate yielding concentration of CPT > 100 ng/ml in vitro.
Cachexia
Willing to avoid cruciferous vegetable intake during the study period (2 weeks)
Intolerance to broccoli/ITC-BSE taste
Participants cannot be taking the following medications because of major pharmacokinetic interactions with celecoxib while being enrolled in the study: abciximab, argatroban, bivalirudin, cilostazol, dabigatran, etexilate, dipyridamole, fondaparinux, heparin, lepirudin, pemetrexed, protein C, rivaroxaban, sibutramine, Ticlopidine, tirofiban, vilazodone and warfarin
If does not have a stable place to live
If does not have a way that the research team can communicate with them by phone or e-mail
Self-reported race other than non-Hispanic white or non-Hispanic black
Gastric bypass
Any evidence of lymphatic or hematogenous metastases
Non-diabetic and obese
Willing to maintain contact with the investigators for 12 months
Capable of performing a simple test for assessing cardiopulmonary fitness
Patients’ availability to check their weight twice per week, during the study duration
Patients with plasma alanine aminotransferase greater than 40 IU/dL
Patients with plasma aspartate aminotransferase greater than 45 IU/dL
Patients with history of known defects in fat metabolism (ie pyruvate carboxylase deficiency, prophyria, fatty acid oxidation defects, primary carnitine deficiencies, organic acidurias, hypoglicemia) will be excluded
Known sarcomatous histologies
Ability and willingness to abstain from all medications and dietary supplements for 3 days prior to kava administration, continuing until a minimum of 7 days after kava administration; topical medications and inhaled medications that do not contain steroids are permitted
Willingness to take kava supplement as instructed
Known hepatobiliary disease or impairment
May continue ongoing antiestrogen
Have predisposing conditions that are consistent with development of aneurysms of the ascending aorta or aortic stress (for example, family history of aneurysms, Marfan-Syndrome, bicuspid aortic valve, evidence of damage to the large vessels of the heart documented by computed tomography (CT) scan with contrast).
Active hemolysis or evidence of biliary sepsis.
(STEP 2) - SECONDARY GENETIC COUNSELING SUBSTUDY:
Concurrent administration of warfarin, full dose aspirin, clopidogrel, apixaban or other medications known to increase the risk of bleeding or with antiplatelet activities
Be colorblind
Site Coordinator identification and contact with as many as possible of the site’s relevant healthcare providers and staff regarding participation in the study intervention; relevant providers may include physicians, nurse practitioners, physician assistants, patient navigators, nurses and other staff who interact directly with breast cancer patients
The SunCoast Community Clinical Oncology Program (CCOP) Research Base does not exclude patients who are participating in other investigational studies; refer to the local Institutional Review Board (IRB) guidelines
Patients must consent and provide both their contact information and that of their representative for a monthly 24-hour dietary recall phone call to be conducted by the Arizona Diet, Behavior and Quality of Life Assessment Lab
African American or Black race
Scheduled prostate cancer consultation to be the first consultation after diagnosis (i.e. not a second-opinion or a consultation following previous discussions of treatment options)
Scheduled to receive an allogeneic HCT at the Dana-Farber Inpatient Hospital or Brigham and Women's Hospital (BWH) under the care of a DFCI physician
Residence in New York, Maine, New Hampshire, Vermont, Connecticut, Rhode Island, or Massachusetts
Does not live in New York, Maine, New Hampshire, Vermont, Connecticut, Rhode Island, or Massachusetts
Registered Nurse (RN) or Doctor of Medicine (MD) degree.
PHASE I: Women who have “dementia” (of any kind) or memory problems listed in their problem list
PHASE I: Women that score > 10 on the Orientation-Memory-Concentration (OMC) test (indicative of dementia)
PHASE I: Women that answer 3 or more of the questions about the benefits and risks of the study incorrectly will be excluded
PHASE II: Women who have “dementia” (of any kind) or memory problems listed in their problem list and we will exclude women that score > 10 on the OMC test (indicative of dementia)
Physicians (medical oncologists, urologists, and radiation oncologists) who regularly treat patients with prostate cancer at one of the two research sites (Wayne State University/Karmanos Cancer Institute [WSU/KCI] or Hopkins) and who can recruit patients to available trials
Patients self-identify as Black, African American, or White and non-Hispanic
CLINICIAN: MSK medical oncology HCPs - specifically identified as attendings, fellows, or advance practice professional (APP) – either a nurse practitioner (NP) or physician assistant (PA) from gastrointestinal (GI), genitourinary (GU) oncology, lymphoma, or bone marrow transplant (four services with a large number of geriatric patients)
CLINICIAN: Willingness to be audio-recorded as per self-report
Children will not be included in the study. The pattern of disease and symptoms are different in children than in an adult population. The web-based tool was designed based on the symptom experience of adults with cancer
Referred to a plastic surgeon by their surgical oncologist for possible reconstruction
Considering a mastectomy
AIM 2: Less than three relevant comorbidities (diabetes, heart disease, stroke and cancer, where cancer counts as 2 comorbidities for women but 1 for men)
AIM 1: Difficulty reading due to poor eyesight (i.e., reporting more than “only a little difficulty”)
Willing to provide access to medical records, insurance and billing data, biospecimens and respond to questionnaires, typically by phone, but possibly to include online or in-person surveys
Patients must be current smokers who smoke at least one cigarette most days per week, or recent quitters who smoked at least one cigarette most days per week (< 3 months); and
At risk for cancer-related infertility, as assessed by their clinician(s), including the oncofertility specialist
MEDICAL CHART REVIEW
PROVIDER TRAINING
TOBACCO CESSATION COACHING
Patients must be willing to be audio recorded during the sessions
Patients who meet this criteria will be referred to OHSU Health Promotion Sports Medicine researcher, Carol DeFrancesco, to complete assessment using stages of change tobacco use readiness ruler and question set
PATIENTS: Already enrolled on hospice, or enrolling on hospice upon discharge from the hospital admission
Board-certified oncologists who practice in any setting in the United States and have a smartphone
Pennsylvania or New Jersey residents\r\n* Telehealth visits for New Jersey residents will only be performed by physicians with a current medical license issued by the state of New Jersey
Patients not residing in Pennsylvania or New Jersey
Staff of the Department of General Internal Medicine (usability test)
Ongoing or prior treatment with traditional disease-modifying anti-rheumatic drugs or biologic agents (RCT)
Living in the community (not institutionalized, etc) (RCT)
Familiarity with and participation in social media (e.g. Facebook) (usability test and RCT)
Hospitalized (RCT)
Located in the New York City (NYC) Borough of Manhattan, Queens, Brooklyn, or the Bronx
Has a roster of at least 100 drivers
Planning on remaining in NYC for at least 1 year, (with no vacations or trips to exceed two months)
Licensed taxi driver for at least three months
Affiliated with a NYC garage
TIPs INCLUSION: Licensed taxi driver for at least two years
TIPs INCLUSION: Affiliated with a NYC garage
TIPs INCLUSION: Willing and able to attend in person TIPs training sessions
TIPs INCLUSION: As per study team judgment, based upon the TIPs screening tool, is socially active among fellow taxi drivers, cares about health issues, and wants to help others improve their health
Does not agree to holding screening health fairs on location (e.g. does not sign enrollment form, or send email confirming agreement, or verbally agree to study team management)
Part-time driver (drives fewer than 35 hours per week); although it is highly unlikely for NYC taxi drivers to work for multiple garages at study baseline, drivers may switch jobs and/or their garage base affiliation while participating in this study; new jobs and/or garage base affiliations will be tracked during follow-up assessments and noted for potential limitations with study retention and intervention contamination; drivers will be allowed to continue the study even if they are no longer working with the initial garage base
First-degree relatives of the cases who test positive for LS
First-degree relatives of the cases who test negative for LS
Lives in the Houston area (Harris county or a contiguous county) (Pre-pilot phase)
Lives in the Houston or surrounding area, or resides in this same area during the time period that coincides with this study (Arms 1-4)
Self-reports hypertension that is not being monitored by a physician and is not being managed with either medication, observation, or lifestyle change (Pre-pilot phase, Arms 1-3)
Orthopedic, neurologic, or musculoskeletal disability that would interfere with the functional task of standing on a weight scale (Pre-pilot phase, Arm 2)
Mothers self-identified as primary caregivers to minor-age children ages 8-17 years old participating in genetic counseling and testing for BRCA 1/2 mutations
Enrolled at 3 trial sites in: (1) Washington, District of Columbia (DC) (Lombardi Comprehensive Cancer Center; LCCC), (2) Boston, Massachusetts (MA) (Dana-Farber Cancer Institute; DFCI), and (3) New York, New York (NY) (Mount Sinai Medical Center; MSMC)
Have at least one of 10 pre-defined anatomic mucosal subsites on view
Must be able to perform oral rinse
Presence of mucosal ulceration at baseline
Oncology providers and staff at Moses Cone Health System (MCHS)
Oncology providers and staff at the University of Pittsburgh Medical Center (UPMC)
African American or White patients who reside in Guilford County, NC or Allegheny County, Pennsylvania (PA)
Uninsured or Underinsured
Fecal Occult Blood Test (FOBT) or fecal immunochemical test (FIT) not completed in the last year
Insured but not underinsured
Incomplete contact information (i.e., no address or phone number on file)
Missouri residents
Calling for themselves
Do not own a smart phone
Unable to see the app and study materials and videos (i.e., are blind, deaf)
RETROSPECTIVE STUDY POPULATION
Admitted to Seidman 6th floor of the Seidman Cancer Center
PROSPECTIVE STUDY POPULATION
Residents covering the gynecologic oncology service
Short portable mental status questionnaire (SPMSQ) score of less than \intact mental functioning\ (3 or more errors)
Patients have never done the ESAS before
Patients whose size and weight would not allow CT scanning
Inclusion and exclusion criteria for the ETRIC randomized study will be the same as the\n        eligibility criteria for the BMT CTN parent studies. Please refer to BMTCTN0901\n        (NCT01339910) Reduced Intensity Regimen vs Myeloablative Regimen for Myeloid Leukemia or\n        Myelodysplastic Syndrome, BMTCTN1101 (NCT01597778) Double Cord Versus Haploidentical,\n        BMTCTN1203 (NCT02208037) Novel Approaches for Graft-versus-Host Disease Prevention Compared\n        to Contemporary Controls, and BMTCTN1301 (NCT02345850) Calcineurin Inhibitor-Free\n        Interventions for Prevention of Graft-versus-Host Disease for detailed eligibility\n        criteria.\n\n        Notes: Enrollment on the BMT CTN 0901 trial (NCT01339910) was closed to further accrual on\n        April 18, 2014. Enrollment on the BMT CTN 1203 trial (NCT02208037) completed accrual on May\n        13, 2016.\n\n        Additional inclusion criteria specific for the ETRIC study will include:\n\n          1. Adult patients (? 18 years)\n\n          2. Speaking and reading proficiency in English (as most of this study's instruments have\n             not been translated and validated in languages other than English)\n\n          3. Willing and able to provide informed consent\n\n          4. Stated willingness to comply with study procedures and reporting requirements\n\n        Exclusion Criteria: N/A
Charts eligible for audit after completion of the educational initiative will be for those CRC and NSCLC survivors presenting for follow-up after the initiative has been completed by site health care providers
Participants will be patients scheduled to visit the Barnes-Jewish Hospital (BJH)/Washington University (WU) Department of Otolaryngology clinic for management of thyroid disorders (ranging from benign to cancerous nodules or masses) that will involve surgical interventions of complete or partial thyroidectomies
CLINICIANS:
Patients who are unable to successfully respond to the PMSA alarm and properly enter their data
Night and/or ‘swing’ shift work (which complicates phone-based reporting system)
Known plans to relocate or move from the Pittsburgh area within the coming 3 months
Other household members are participating or have participated
Active plans to leave the country in the next 3.5 months
Only women considering mastectomy will be eligible; that is, women who have definitely selected lumpectomy will not be approached
Current treatment with lithium. Drug interactions between filgrastim and lithium, which may potentiate the release of neutrophils, have not been fully evaluated.
Be willing and capable of swishing/gargling oral gel/solution as required per protocol.
Cardiac pacemaker with heart rate (HR) set at a fixed rate and treatment with concomitant medication that may limit increase in HR in response to hypotension (example, high-dose beta blocker).
Prostate volume > 20cc and height at least 22mm (at the area(s) to be biopsied) as verified by ultrasound or MRI
Fatigue or lethargy
Cachexia or edema
Cough, dyspnea, airway hyperreactivity, or nasal inflammation
Arthralgia or myalgia
Any abnormality that would be scored as NCI Common Terminology Criterial (CTC) grade 4 toxicity that is unrelated to HIV, its treatment, or to KICS that would preclude the use of all of the study treatments or the ability to monitor the natural history of KICS untreated
Access to a device capable of receiving plain text messages
Criteria 5, Metastatic liver lesions for injection must be without necrosis (dead tissue )and must be be located where any tumor swelling will not lead to gall bladder tract obstruction or lead to bleeding risk
Photosensitizing drugs, medications which might generate fluorescence or according to label, might generate photochemical reaction. These include hematoporphyrin derivatives and purified fractions; Photofrin®; and precursors of protoporphyrin IX (5-Aminolevulinic acid) used in Gliolan or Hexvix
mammography and/or US and/or MRI abnormality(ies) consistent with malignancy.
Patient dosed with UCART19 who completed or discontinued early from a sponsored or from any investigator-initiated study that tested UCART19, or patients who were administered UCART19 under a special access scheme (compassionate use);
Individual test orders; defined as single biomarker assessment
Due to the complexity of state and federal requirements governing the participation\n             of prisoners in research, prisoner-patients shall not be approached for participation\n             in the Registry.
Patients who have not achieved a 1-log reduction in BCR-ABL transcript levels compared with baseline as determined by local standards or > 10% IS [International Standard]) documented at 3.0-6.5 months since the initial start of dasatinib therapy.
Subject who is unwilling to minimize exposure with his/her blood or other body fluids to individuals who are at higher risks for HSV-1 induced complications (eg, immunosuppressed individuals, HIV-positive individuals, pregnant women, or children under the age of 1 year) during talimogene laherparepvec treatment and through 30 days after the last dose of talimogene laherparepvec
having an easily accessible email address
lifetime ever purchase of any e-cigarette
Evidence of typical BCR-ABL transcripts (b3a2 and/or b2a2) at the time of CML-CP diagnosis i.e. prior to first start of TKI treatment which are amenable to standardized RT-PCR quantification\
Potassium (suggested keep to prevent issues with QT and/or rhythm abnormalities)
Magnesium (suggested keep to prevent issues with QT and/or rhythm abnormalities)
Inability to determine the QT interval on ECG, except for patients with evidence of measurable QT interval at the time of CML diagnosis (e.g. prior to first start of TKI treatment) and who have no documented clinical signs of cardiovascular disease and/or clinical signs of conduction abnormality.
poor cytogenetics
no CHR by 12 weeks (whether lost or never achieved)
no partial cytogenetic response by 24 weeks (ie, 1 to 35% Ph-positive) (whether lost or never achieved) no major cytogenetic response by 52 weeks (ie, ?35% Ph-positive) (whether lost or never achieved)
Subjects who will have administration of methylene blue or any blue dye used for sentinel node mapping procedures.
able to stand independently
Use of any ongoing medications which might generate fluorescence or, according to the medication label, might generate a photochemical reaction. These include haematoporphyrin derivatives and purified fractions, Photofrin®, and the precursors of protoporphyrin IX (5-Aminolevulinic acid) used in Gliolan or Hexvix.
Specific serum electrolyte levels
Heart rhythm disturbances
Inclusion Criteria:\n\n        Ostomy patients who:\n\n          -  Have healthy peristomal skin\n\n          -  Are within 12 weeks post op\n\n        Exclusion Criteria:\n\n        Ostomy patients who:\n\n          -  Have a fistula, wound, lesion or suspected infection in the peristomal area\n\n          -  Are in-patient in healthcare facility
Inclusion Criteria:\n\n          1. age 18 or older\n\n          2. former smoker who quit during pregnancy as assessed via self-report\n\n          3. smoked an average of greater than or equal to 1 cigarette per day during the year\n             prior to the current pregnancy\n\n          4. gestational age < 33 weeks and ability to attend an in-person visit at University of\n             Texas MD Anderson Cancer Center (UTMDACC) between 30-33 weeks of gestational age\n\n          5. can speak, read and write in English.\n\n          6. must have a functioning home or personal cell phone\n\n        Exclusion Criteria:\n\n        1) high-risk pregnancy or known negative birth outcome
Inclusion Criteria:\n\n          1. age 18 or older\n\n          2. former smoker who quit during pregnancy as assessed via self-report\n\n          3. smoked an average of greater than or equal to 1 cigarette per day during the year\n             prior to the current pregnancy\n\n          4. gestational age < 33 weeks and ability to attend an in-person visit at University of\n             Texas MD Anderson Cancer Center (UTMDACC) between 30-33 weeks of gestational age\n\n          5. can speak, read and write in English.\n\n          6. must have a functioning home or personal cell phone\n\n        Exclusion Criteria:\n\n        1) high-risk pregnancy or known negative birth outcome
Patients who are at least 18 years old, who have been identified by the BMT social worker as having a cancer or pre-cancer diagnosis and are Minnesota residents with potential legal needs (see the list below), expected to proceed to transplant, considered the primary client for legal services or are at least 18 years old and have a legal-designate.
The patient or legal designate must be able to complete study tools by the BMT social workers. Interpreters will be provided by UMMC for non-English speaking pt's and BMT social workers will assist patients who cannot read.
Patients who do not have any identified any potential legal needs, or whose legal needs are beyond those covered in the I-Help model.
Patients who are not residents of Minnesota as CALL attorneys are only licensed to practice law in Minnesota.
Permanent or temporary housing available within a 60 minute (min) commute from the SCCA
Symptoms of dysphagia
For those enrolled in Adjuvant Treatment with Optune™, patients are excluded if they are < 22 years of age, have an active implanted medical device, a skull defect, bullet fragments in the head, sensitivity to conductive hydrogels, a scalp condition that might interfere with wearing the device, or GBM that is not supratentorial.
Indication of systemic treatment for the relapsed EOC, FTC or PPC.
Males have undergone sterilization with appropriately confirmed absence of sperm in the post-vasectomy ejaculate, or
CRITERIA FOR PLASMA GENOTYPING
Subject who is unwilling to minimize exposure with his/her blood or other body fluids to individuals who are at higher risks for HSV-1 induced complications (immunosuppressed individuals, HIV-positive individuals, pregnant women, or children under the age of 1 year) during talimogene laherparepvec treatment and through 28 days after the last dose of talimogene laherparepvec.
BPDCN
Hurthle cell
Insular
One or more measurable lesions that have progressed according to RECIST 1.1 within 12 months (an additional month will be allowed to accommodate actual dates of performance of screening scans, ie, within ?13 months) after Iodine-131 therapy, despite demonstration of radioiodine avidity at the time of that treatment by pre- or posttreatment scanning. These participants must not be eligible for possible curative surgery.
DCIS must be >= 5 mm of DCIS on one single core; can be < 5 mm if DCIS is identified on multiple cores (at least 2 cores)
Unexplained/undiagnosed abnormal uterine bleeding (concern for undiagnosed endometrial cancer)
Has responded (achieved a CR or PR) to BV or BV-containing regimens, if previously treated with BV.
Elevated serum hCG (in cases of choriocarcinoma); elevated hCG or measurable disease (in cases of PSTT or ETT)
Open wounds or unhealed fractures within 28 days of starting study treatment
Positive HBs Ag or positive HBV viremia, Positive HCV viremia.