Patients previously untreated or treated with drug therapy for epithelioid hemangioendothelioma (EHE) are eligible; there is no limit on the number of prior regimens used to be eligible
Children with definitive confirmatory eligible histologic or cytological diagnosis of eligible CNS tumor within the brain or spinal cord, who have not previously received either irradiation or chemotherapy (except corticosteroids) will be eligible for study entry
Patients with >= grade 2 hypothyroidism due to history of autoimmunity are not eligible; note: hypothyroidism due to previous irradiation on thyroidectomy will not impact eligibility
Patients with known macular degeneration, uncontrolled glaucoma, or cataracts are not eligible
Patients with rheumatoid arthritis and other arthropathies, Sjogren’s syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible
Patients with pathologic staging of ypN0(i+) or ypN0(mol+) are eligible
Patient who have undergone either a total mastectomy or a lumpectomy are eligible; (patients who have had a nipple-sparing mastectomy are eligible)
For patients with known molecular alterations, institution has been notified that patient is deemed eligible for Arm T per review of molecular testing reports
REGISTRATION STEP 2-RANDOMIZATION: Patients must be eligible for at least one of the currently active investigational treatment arms (S1612B or S1612C); if the patient does not meet eligibility criteria for at least one active investigational arm, then the patient is not eligible for S1612
Patients must have baseline troponin test performed for eligibility; however, no associated values must be met in order for the patient to be eligible
Patients with multifocal or multicentric invasive disease are eligible as long as all the lesions for which HER2 characterization is available are HER2 negative
Patients enrolled on AALL0932, with Down syndrome, meeting the following criteria will NOT be eligible to continue on AALL0932 but WILL BE eligible to enroll on the DS HR B-ALL stratum of this study at the end of Induction: \r\n* Day 29 MRD >= 0.01%\r\n* MLL rearrangement\r\n* Hypodiploidy (n < 45 chromosomes and/or DNA index < 0.81)
Patients must be newly diagnosed with histologically confirmed intracranial ependymoma; patients with classic ependymoma (WHO II) or anaplastic ependymoma (WHO III) are eligible, as are various subtypes described as clear cell, papillary, cellular or a combination of the above
Patients with disease limited to the skin are not eligible, regardless of how wide-spread
Pregnancy; lactating females must cease expression of milk prior to signing consent to be eligible
Patients with known active cutaneous squamous cell carcinoma (includes keratoacanthoma or mixed keratoacanthoma subtype) are not eligible; patients who have fully excised lesions with dermatologic confirmation of absence of disease are eligible
No late relapse with completely surgically resectable disease; patients with late relapses (defined as relapse >= 2 years from the date of completion of the last chemotherapy regimen) whose disease is completely surgically resectable are not eligible; patients with late relapses who have unresectable disease are eligible
Patients with subependymal giant cell astrocytomas (SEGAs) are not eligible
Patient must be eligible for treatment with nivolumab; patients previously treated with nivolumab, pembrolizumab or atezolizumab and who have progressed are eligible; patients with targetable with EGFR or ALK mutations are eligible after disease recurrence or progression after at least one targeted therapy for advanced or metastatic disease
HER2+ and HER2- patients are eligible
All patients must have diagnostic laparoscopy with diagnostic washings for cytology; both cytology positive and negative patients are eligible for enrollment, but only cytology negative patients will be included in the primary analyses; gross peritoneal disease is not eligible
Patients allergic to eggs are not eligible
Patients with uncontrolled hyperlipidemia (total cholesterol > 350 or triglycerides > 300) are NOT eligible for participation
Cystoscopically and radiographically confirmed cT2-4a cN0 cM0 disease. Patients with cT4a disease invading into the prostatic stroma with no cystoscopic confirmation of muscle invasion are eligible.
Patients with recurrent brainstem tumors with an atypical presentation who have undergone biopsy are eligible provided there is histologic confirmation of malignant glioma WHO II-IV; these patients must undergo Rb1 screening; these patients must have radiographic evidence of progression
Patients with secondary malignant gliomas will be eligible for this study but should conform to all other eligibility requirements; patients with low-grade gliomas are excluded
PHASE I (STRATUM 1): Patients with progressive DIPG, as defined by progressive neurologic abnormalities or worsening neurologic status not explained by causes unrelated to tumor progression (e.g., anticonvulsant or corticosteroid toxicity wean, electrolyte disturbances, sepsis, hyperglycemia, etc.), OR an increase in the bi-dimensional measurement, taking as a reference the smallest disease measurement recorded since last treatment, OR the appearance of a new tumor lesion since diagnosis \r\n* Please note:\r\n** Patients with a radiographically typical DIPG, defined as a tumor with a pontine epicenter and diffuse involvement of more than 2/3 of the pons, are eligible without histologic confirmation\r\n** Patients with pontine lesions that do not meet these radiographic criteria will be eligible if there is histologic confirmation of malignant glioma WHO II-IV. These patients must have radiographic evidence of progression
Previous treatment with investigational agents that inhibit MDM2 or MDMX activity (some MDM2-treated patients may be eligible)
Patients being treated with any other experimental agents/clinical trials are not eligible for participation; if the patient is on any investigational agent, a wash-out period of minimum 2 weeks prior to registration is mandatory for the patient to be eligible for the study
Patients who have any prior chemoimmunotherapy are not eligible; NOTE: the use of steroids to control the disease is permitted and does not have a washout period
Unifocal primary disease NOTE: Patients with multifocal and/or multicentric in breast cancer, or evidence of EIC are NOT eligible. Patients with contralateral disease will remain eligible.
Patients who have had prior surgical intervention for lymphoma, unless performed for the sake of tissue diagnosis or on an urgent basis for disease-related threat to life, limb, or organ function, are not eligible
Patients with a prior malignancy will NOT be eligible for participation aside from the following exception:\r\n* Patients who have had any curatively treated invasive malignancy and have been disease free without treatment for 1 year prior to study entry ARE eligible for participation
Patients who have received prior treatment with oral or intravenous fenretinide as a single agent are eligible, provided they did not experience severe toxicity related to fenretinide
Patients who have received prior treatment with oral or intravenous fenretinide as a single agent are eligible, provided they did not experience severe toxicity related to fenretinide
Other \r\n* Lung cancer with pleural effusion (wet IIIB) are not eligible \r\n* Recurrent cancers are not eligible \r\n* Diffuse metastatic spread confined to one organ system is ineligible; examples of this include leptomeningeal spread in the CNS and peritoneal carcinomatosis
Patients with the following pure histologies of endometrial or ovarian cancer are not eligible for enrollment: germ cell, sex cord stroma, carcinosarcoma, or sarcoma.
Patients with active bacterial infections with systemic manifestations (malaise, fever, leukocytosis) are not eligible until completion of appropriate therapy. Patients taking low-dose antibiotics for biliary obstruction are exempted from this exclusion criterion.
A prior or concurrent metastatic second malignancy within 3 years, even if it does not require active therapy; for example, patients with concomitant indolent B-cell malignancies will not be eligible; patients with a prior resected in-situ or stage I malignancy felt to be cured will be eligible
Clinical American Joint Committee on Cancer (AJCC) (AJCC, 7th ed.) II, IIIA or IIIB (with non-operable disease; non-operable disease will be determined by a multi-disciplinary treatment team within 60 days prior to registration; note: for patients who are clearly nonresectable, the case can be determined by the treating radiation oncologist and/or a medical oncologist or pulmonologist \r\n* Patients who present with N2 or N3 disease and an undetectable NSCLC primary tumor are eligible\r\n* Patients who refuse surgery are eligible\r\n* Patients who develop local recurrence after surgery and rendered candidate for definitive concurrent chemoradiation are also eligible\r\n* Patients who have received systemic treatment (up to 4 cycles of induction chemotherapy, or up to 6 months of targeted therapy) are eligible
Patients with active lesions suspicious for keratoacanthomas/cutaneous squamous cell carcinoma (cSCC); patients who have excision of keratocanthomas/cSCC, with dermatologic confirmation of the absence of active disease may become eligible
Patients must have at least one of the following for a diagnosis/disease status:\r\n* Unresectable disease\r\n* Metastatic disease\r\n* Medically unfit for surgical resection but with an expected survival of > 3 months, Eastern Cooperative Oncology Group (ECOG) < 2 and New York Heart Association (NYHA) status =< II\r\n* Disease where no conventional therapy leads to a survival benefit > 6 months in the respective cohort and line of therapy for which the patient is otherwise eligible\r\n* Actionable alterations determined by FoundationOne
Follicular grades IIIA or IIIB are not eligible
Patients previously treated with anti-CD19 CAR or other adoptive cell therapies will be eligible if all other eligibility criteria are met but will be evaluated as a separate strata from CAR-naive patients in the expansion phase; circulating CAR T cells must be < 5% in peripheral blood
PHASE I: Patients with central nervous system (CNS) involvement are eligible provided that they are asymptomatic and in the opinion of the study principal investigator (PI) have a reasonable expectation that disease burden can be controlled in the interval between enrollment and T cell infusion; patients that have a significant neurologic deterioration will be not be eligible for T cell infusion until alternate therapies result in neurological stabilization
PHASE II: Patients with CNS involvement are eligible provided that they are asymptomatic and in the opinion of the study PI have a reasonable expectation that disease burden can be controlled in the interval between enrollment and T cell infusion; patients that have a significant neurologic deterioration will be not be eligible for T cell infusion until alternate therapies result in neurological stabilization AND
No prior genetically modified cell therapy that is still detectable or virotherapy allowed; patients who are otherwise eligible but have detectable circulating CAR T cells of < 5% will be eligible, but will be evaluated as a separate strata from CAR-naive patients in the phase 2 portion of the study
Phase I and expansion cohort: Up to two prior non-taxane chemotherapy regimens for metastatic disease are permitted for patients enrolled on the phase I portion of the trial; patients with HER2/neu positive breast cancer are not eligible; patients treated with prior anthracycline therapy as neoadjuvant, adjuvant, or metastatic therapy are not eligible unless the following conditions are met: (a) prior cumulative doxorubicin dose is =< 240 mg/m^2 (or epirubicin dose is =< 400 mg/m^2), and (b) left ventricular ejection fraction (LVEF) obtained at baseline is at least 50% (or >= 5% above lower institutional limits of normal whichever is higher); patients with estrogen receptor (ER)-positive disease are required to have relapse or progression on at least one line of endocrine therapy
Confirmation of HER2 positivity:\r\n* Phase I only: Patients with leptomeningeal disease from ependymomas, gliomas, and medulloblastoma will be eligible for phase I but are not required to have HER2 analysis; HER2 testing is only required for breast cancer patients with leptomeningeal metastases; HER2 positive (immunohistochemistry [IHC] 3+ and/or FISH positive; IHC 2+ HER2 patients are eligible with reflex FISH positive testing with the ratio >= 2.0) breast cancer patients with leptomeningeal metastases by magnetic resonance imaging (MRI) or CSF (if MRI is negative) are eligible\r\n* Phase II only: ALL patients with HER2+ cancers of other histology will be allowed to enroll in phase II if they have leptomeningeal disease\r\n* NOTE: review will be performed for cases not reviewed at the participation institution for confirmation, but will not preclude patients from entering the trial (pathology report showing HER2 positivity is sufficient for registration)
Patients with documented history of no response to cladribine, and without 50% improvement in platelets, hemoglobin or granulocytes; this exclusion does not apply to HCLv; these patients are eligible regardless of prior response to cladribine (CDA)
Patients with a known nonmalignant disease that is not clearly defined will need to be discussed with the protocol principal investigator (PI) (Dr. Lauri Burroughs) and potentially the nonmalignant board to determine if they are eligible for HCT on this study
Patients who have been treated with prior secondary hormonal manipulations with proposed investigational rationale for having efficacy against AR-V7 splice variants. This includes but is not limited to EPI-002 and AZD5312. (Note: patients previously treated with abiraterone, orteronel [TAK-700], apalutamide [ARN-509], galeterone, or VT-464 will be eligible for this study. Patients who have received prior chemotherapy will also be eligible for this study).
All stages of disease (IA through IVB) where radiation therapy is being considered for local control are eligible. Patients who are concomitantly undergoing systemic therapy for more advanced stage disease are eligible.
Inclusion Criteria:\n\n        Patients fulfilling the following criteria will be eligible to provide continued long-term\n        follow-up data as part of this study:\n\n          1. Enrolled and randomized on the BMT CTN 0702 protocol.\n\n          2. Alive at the completion of BMT CTN 0702 protocol specified follow-up defined as 4\n             years post-randomization.\n\n          3. Patients without evidence of disease progression at the completion of BMT CTN 0702\n             protocol specified follow up.\n\n          4. Signed Informed Consent Form.\n\n          5. Patients with the ability to speak English or Spanish are eligible to participate in\n             the HQL component of this trial.\n\n        Inclusion Criteria for Optional Long-term Lenalidomide Maintenance Therapy:\n\n        Patients fulfilling the following criteria will be eligible to provide continued long-term\n        follow-up data AND receive long-term lenalidomide maintenance therapy as part of this\n        study:\n\n          1. Enrolled and randomized to BMT CTN 0702.\n\n          2. Completion of 3 years of maintenance therapy on BMT CTN 0702.\n\n          3. Registered in the mandatory Revlimid REMS® program (formerly the RevAssist® for Study\n             Participants (RASP) program), and be willing and able to comply with the requirements\n             of the Revlimid REMS® program, including counseling, pregnancy testing, and phone\n             surveys.\n\n          4. Signed informed consent form.\n\n          5. Patients with the ability to speak English or Spanish are eligible to participate in\n             the HQL component of this trial.\n\n        Exclusion Criteria:\n\n        Patients who meet any of the following criteria will be ineligible to receive long-term\n        lenalidomide maintenance therapy as part of this study:\n\n          1. Patients who have evidence of disease progression prior to enrollment.\n\n          2. Patients who were discontinued from BMT CTN 0702 lenalidomide maintenance therapy, for\n             any reason, prior to the completion of the 3 years of 0702 maintenance.\n\n          3. Female patients who are pregnant (positive - Beta Human Chorionic Gonadotropin) or\n             breastfeeding.\n\n          4. Females of childbearing potential (FCBP) or men who have sexual contact with FCBP\n             unwilling to use contraceptive techniques during the length of lenalidomide\n             maintenance therapy.\n\n          5. Patients who experienced thromboembolic events while on full anticoagulation during\n             prior therapy with lenalidomide.\n\n          6. Patients unwilling to take Deep Vein Thrombosis (DVT) prophylaxis.\n\n          7. Patients who developed a second primary malignancy, excluding non-melanoma skin\n             cancers after initiation of lenalidomide maintenance therapy on BMT CTN 0702.
Diagnosis\r\n* Patients with CNS3 disease\r\n* Patients with isolated extra-medullary relapse involving only sanctuary sites (eg. testicular relapse) but patients with extramedullary disease involving nodal or other non-sanctuary sites are eligible\r\n* Patients with isolated testicular relapse \r\n* Patients with Philadelphia chromosome positive (Ph+) T-ALL/T-LLy\r\n* Patients with Down syndrome \r\n* Patients with pre-existing grade 2 (or higher) peripheral motor or sensory neurotoxicity per CTCAE 4.03 \r\n* Patients with a history of prior veno-occlusive disease (VOD)/sinusoidal obstruction syndrome (SOS) or findings consistent with a diagnosis of VOD/SOS, 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 with laboratory evidence of autoimmune disease (e.g. positive antinuclear antibody [ANA] or lupus anticoagulant) without associated symptoms; vitiligo, or mild autoimmunity not impacting the function of organs, such as Hashimoto or psoriasis may be eligible for study
Patients are eligible >= 6 weeks after therapeutic 131I-MIBG or stem cell infusion to support 131I-MIBG, whichever is later
Patients with extrahepatic disease are eligible
Patients with evidence of large B cell transformation (transformed disease) are not eligible; if in the opinion of the investigator there is high suspicion of transformed disease based on imaging (eg high standardized uptake value [SUV] uptake > 10 on the PET scan) and a biopsy of the suspected site is not feasible, then those patients are not eligible
PRE-CHEMORADIATION SAMPLE COLLECTION: Patients with muscularis propria invasion clinical stages 2 to 4 (T2-4a, N0 or N+, M0 or T1 with N+), who are not candidates for radical cystectomy\r\n* Patients may have undergone partial cystectomy for removal of bladder tumor prior to chemoradiation; patients who have down-staged from M1 disease to M0 with prior platinum-based chemotherapy will be eligible\r\n* Staging is determined prior to chemoradiation
STUDY TREATMENT: Patients with muscularis propria invasion clinical stages 2 to 4 (T2-4a, N0 or N+, M0 or T1 with N+), who are not candidates for radical cystectomy\r\n* Patients may have undergone partial cystectomy for removal of bladder tumor prior to chemoradiation; patients who have down-staged from M1 disease to M0 with prior platinum-based chemotherapy will be eligible\r\n* Staging is determined prior to chemoradiation
Have recurrent or refractory/unresectable disease for which there is no known curative therapy\r\n* Wild type-GIST: patients with recurrent or progressive disease will be eligible; newly diagnosed patients with resectable localized disease will not be eligible; newly diagnosed patients with metastatic disease and newly diagnosed patients with residual tumor following surgical debulking will be eligible\r\n* PHEO/PGL: patients with recurrent or progressive disease will be eligible; newly diagnosed patients with PHEO/PGL that is metastatic at diagnosis and/or unresectable will be eligible; patients with PHEO/PGL with localized (non-metastatic), resectable disease will not be eligible\r\n* Renal cell cancer associated with HLRCC: patients with localized, resectable HLRCC-associated renal cell cancer will not be eligible; patients with metastatic and/or unresectable HLRCC-associated renal cell cancer will be eligible
Patients may have received any prior therapy deemed necessary for them to be eligible to HDT/ASCT except for patients whom have progressed while on Zydelig. Patients who have responded to Zydelig previously are eligible for enrollment on the protocol
Patients will not be eligible if they have a history of color vision defects
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 not be eligible for transplant in this trial
Female patients who are pregnant or lactating are not eligible (because treatment involves unforeseeable risks to the embryo or fetus)
Patients with evidence of another malignancy or benign tumor requiring chemotherapy or radiation therapy are excluded; however, those patients with a plexiform neurofibroma requiring treatment will be eligible as selumetinib has documented activity in plexiform neurofibromas
Patients with bulky disease are eligible for study provided that the patient not undergo radiation therapy until 30 days after the end of blinatumomab administration
Patients may have received chemotherapy or radiation for a previous, curatively treated malignancy provided at least 2 years have elapsed and there is no current evidence of disease (patients with previous or concurrent additional skin cancers will be eligible); patients with chronic lymphoid or leukemic malignancies are eligible with or without active disease as long as they have not had treatment within the past three months
Patients should not be eligible for potentially curative surgical intervention in the case of oligometastatic disease at the time of enrollment or must have actively refused after explicit discussion of potential benefit of this intervention with multidisciplinary team
Per investigator's judgment, be eligible for treatment with valganciclovir.
Patients with multifocal or multi-centric disease are eligible if the treating clinician has determined the patient should be treated as ER+ and HER2- negative
Patients must have failed a prior >= 4-mponth course of either MMF/Myfortic or cyclophosphamide before being eligible for the study (determined at >= 1 week before start of mobilization); “failure” is defined as evidence of disease progression or absence of improvement; the response prior to MMF of cyclophosphamide will be assessed by the participating site study rheumatologist
Failure to one induction course of chemotherapy (these patients will be analyzed separately); patients who require steroids, ara-c or hydrea to manage disease symptoms prior to finalization of diagnosis and treatment plan are allowed and eligible
Eligible for LDAC therapy, based on Investigator assessment
Eligible for therapy for the lymphoid malignancy which has a high likelihood of a curative result in the opinion of the investigator
MPNST for which standard therapy is not curative, including patients with surgically unresectable lesions, progression (WHO criteria) or recurrence of an MPNST in a previously radiated field (if it has been at least 4 weeks prior to registration since the last dose of radiation); Note: patients with metastatic disease also are eligible for participation
Patients with clonal evolution and no other criteria for accelerated phase will be eligible for this study
Has active hepatitis B or C. Patients with serologic evidence of prior exposure are eligible.
Patients with cytopenias below these thresholds deemed to be the result of disease will be considered eligible
Patients on EIADs are not eligible, unless the antiepileptic drug can be safely tapered and discontinued before C1D1.
FLT3-ITD and/or FLT3-D835 mutated patients with relapsed/refractory AML (any number of relapses) including patients who may have been previously exposed to one or more FLT3-inhibitor therapies will be eligible for the phase I portion of this study
Patients must be eligible for TACE
ADDITIONAL CRITERIA FOR STUDY CONTINUATION: Have a surgically resected (R0 or R1) American Joint Committee on Cancer (AJCC) pathologic stage I or stage II adenocarcinoma of the head, neck, or uncinate of the pancreas; (following study treatment #1, if the patient’s tumor is found intraoperatively to be limited to the distal portion (body or tail) of the pancreas and is resected by distal pancreatectomy, the patient may continue to receive study treatments but will be considered non-evaluable for the primary and efficacy endpoints and will be followed for additional endpoints;) the patients with an R2 resection will not be eligible for the continuation of the study; patients with intraoperative findings of metastatic disease will not be eligible for the continuation of the study
Patients with newly diagnosed or progressive DIPG as confirmed by gadolinium enhanced magnetic resonance imaging (MRI) are eligible; MRI must demonstrate that at least 2/3 of the tumor is situated in the pons and that the origin of the tumor is clearly in the pons; biopsy is not required; tumors with features not typical of diffuse intrinsic brainstem glioma are not eligible; these include dorsally exophytic brainstem gliomas, cervicomedullary junction tumors, and focal low grade gliomas of the midbrain or brainstem which should undergo resection and pathologic evaluation; patients, who have received re-irradiation for progression of the tumor, will be eligible if they show evidence of measurable progressive disease after the re-irradiation; patients at diagnosis with involvement of the spine will not be eligible, however if at progression features of spine involvement are present they will be eligible for stratum II
At least 2 weeks should have elapsed since the last dose of chemotherapy and must have recovered from the acute effects of prior therapy (grade 1 or better); however patients who have a > 50% rise in peripheral blast count (confirmed twice) or > 50% growth of lymph nodes are immediately eligible; patients who have relapsed following autologous or allogeneic bone marrow transplant (BMT) are eligible
Patients with neurofibromatosis are eligible
Patients with porphyria are not eligible
Patients with multiple viral infections including AdV are eligible if their AdV infection is persistent despite standard therapy as defined above. Patients with multiple infections with one or more reactivation and one or more controlled infection are eligible to enroll.
Patients must have high-risk neuroblastoma as defined by the Children's Oncology Group (COG) Risk Stratification Schema\r\n* Patients with International Agreement on Staging (INSS) stage 4 are eligible with the following:\r\n** MYCN amplification, regardless of age or additional biologic features OR\r\n** Age > 18 months, regardless of biologic features OR\r\n** Age 12-18 months, with any of the 3 following unfavorable biologic OR features: MYCN amplification, unfavorable pathology, and/or deoxyribonucleic acid (DNA) index = 1\r\n* Patients with INSS stage 3 are eligible with the following:\r\n** MYCN amplification, regardless of age or additional biologic features OR\r\n** Age > 18 months with unfavorable pathology, regardless of MYCN status\r\n* Patients with INSS stage 2a or 2b are eligible with the following:\r\n** MYCN amplification, regardless of age or additional biologic features\r\n* Patients with INSS stage 4s are eligible with the following:\r\n** MYCN amplification, regardless of additional biologic features
Patients with multiple CMV, EBV, adenovirus, HHV6 and BK virus infections are eligible given that each infection is persistent despite standard therapy; patients with multiple infections with one or more reactivation and one or more controlled infection are eligible to enroll
Only patients with mutated rat sarcoma (RAS) (KRAS and NRAS) mutations are eligible to participate (Phase II only)
An international normalized ratio (INR) =< 1.5 (patients who are therapeutically anticoagulated for unrelated medical conditions such as atrial fibrillation and whose antithrombotic treatment can be withheld for operation will be eligible)
Patients who have met the above criteria and who have undergone CRS and HIPEC in the past 18 months for the forementioned disease processes without evidence of recurrence will be eligible for participation in this study for analyzing ability to achieve complete cytoreduction, morbidity, progression and survival
F. Any one of the below complications\r\n* Vaso-occlusive crises; eligible for hydroxyurea*: at least 3 hospital admissions in the last year; eligible for hematopoietic stem cell transplantation (HSCT): more than 1 hospital admission per year while on maximal tolerated dose of hydroxyurea*\r\n* Acute chest syndrome (ACS); eligible for hydroxyurea*: 2 prior ACS while > 3 years of age and adequately treated for asthma; eligible for HSCT: any ACS while on hydroxyurea*\r\n* Osteonecrosis of 2 or more joints; eligible for hydroxyurea*: and significantly affecting their quality of life by Karnofsky score 50-60; eligible for HSCT: and on hydroxyurea* where total hemoglobin increase less than 1 g/dL or fetal hemoglobin increases < 2.5 times the baseline level\r\n* Red cell alloimmunization; eligible for hydroxyurea*: transfusion-dependent; eligible for HSCT: total hemoglobin increase < 1 g/dL while on hydroxyurea*\r\n* Note: hydroxyurea at maximum tolerated dose
Although rare, the only exception to this would be patients with Hashimoto’s thyroiditis who ARE eligible for participation
Patients who have had a positive SLNB but decline completion ALND are not eligible
Previous therapy:\r\n* It is expected that patients will have received upfront standard of care therapy for their respected disease\r\n* Patients who relapse after either single or tandem autologous BMT are eligible (> 6 months must have elapsed from start of last BMT)\r\n* Patients must be recovered from the acute toxicities of any prior chemo/radio/immunotherapy or BMT
For dose escalation study, patients must have histological confirmation of solid tumors that is metastatic or unresectable. For expansion cohorts, patients must have metastatic or unresectable GIST, melanoma, or uncategorized tumors with tumor biopsies that are positive for c-KIT mutations by polymerase chain reaction (PCR) or immunohistochemistry (IHC). For patients enrolled in the melanoma expansion cohort, only select KIT mutations will be eligible. Patients with mutations in exon 13 V654X, 14 T6701, 17 D816X and all exon 18 mutations will not be eligible for enrollment.
Patients with a radiosurgery boost or fractionated stereotactic boost as a part of their treatment plan are not eligible
Patients with major skull defects (such as missing bone without replacement) are not eligible
Patients in whom therapy for APL was initiated on an emergent basis are eligible (patients may have already started treatment with ATRA, ATO, and/or one dose of idarubicin due to the urgency to start therapy early)
Patients who require or likely to require corticosteroids or other immunosuppressives for intercurrent disease are NOT eligible
Patients with refractory-relapsed ALL of any age are eligible, provided they are not eligible for regimens of higher priority
Patients are eligible if, based on the postoperative CT scan, partial breast irradiation (PBI) is judged to be technically deliverable
Men are not eligible for this study
During phase II: all patients with relapsed disease will be eligible if they have received a minimum of 1 prior standard therapy and a maximum of 2 prior treatments (one of which must be a purine analog and/or an alkylating agent) for B-CLL and have developed relapse disease\r\n* Note: patients who have refractory disease (defined as – progressive disease on last treatment, or less than 6 months of clinical response to the last treatment) will not be eligible
Patients with cytogenetic abnormalities suggesting an improved prognosis [t(8:21), t(15;17) and inv(16)] will be eligible for transplantation in first remission
Patients can also be deemed not eligible for transplant because of specific organ toxicity; specifically, patients with pre-existing compromise to the heart, lungs, kidney, central nervous system (CNS) or liver may be excluded
Previous Therapies\r\n* Patients who are currently being treated with intrathecal (IT) IL-2 for LMD are eligible; no wash out period is required\r\n* Patients who have been previously treated with other IT therapies are eligible, as long as there is at least a 2 week wash out period\r\n* Patients who have previously received therapy with systemic TIL therapy are eligible\r\n* Patients with ventriculo-peritoneal (VP) shunts must have VP shunts with on/off valves and must be expected to tolerate VP shunt valve off for more than 6 hours; patients who have received CNS irradiation, including whole brain radiation or stereotactic radiosurgery, are eligible, if they are at least 1 weeks post CNS-irradiation (Cohort D); patients who are currently being treated with IT IL-2 for LMD are eligible; no wash out period is required. (Cohort D)
FGFR testing of patients will be performed at the investigators' discretion up to a max. of 90 days prior to start of screening. Investigators should ensure all patients will be eligible in terms of disease status and lines of treatment within this timeframe.
Patients are eligible unless their treatment is to be guided by a higher priority protocol
Prior history of standard dose focal RT to 60 Gy in 30 fractions or 59.4 Gy in 1.8 Gy fractions, or equivalent or lower doses; patients who have received prior treatment with non-standard RT dose and fractionation schemes are still eligible, provided they have only received a single course of RT; however, subjects treated with interstitial brachytherapy or single-fraction stereotactic radiosurgery are not eligible for this trial
Patients who test positive for infectious hepatitis types A, B, or C within 14 days of registration are NOT eligible for participation
Complex stenoses (Bismuth grade IV) will not be eligible for the trial
Patients who are unable to swallow the medication in its prescribed form are not eligible; the drug cannot be administered via gastric feeding (G)-tube; there will be no exceptions for this criteria
Patients with an active or uncontrolled infection; patients on prolonged antifungal therapy are still eligible if they are culture and biopsy negative in suspected radiographic lesions and meet other organ function criteria
Patients must have histologic or cytologic diagnosis of non-melanoma skin cancer (NMSC) or lymphomas other than B-cell lymphomas; as both of those terms are categories rather than specific diagnoses, specific guidance on eligible tumor types is provided below
Patients are not eligible who have had major surgery =< 14 days of registration; please contact principle investigator (PI) and quality assurance monitor (QAM) for questions about specific surgical procedures
Patients with feeding tubes are eligible for the study
Patients with hypothyroidism that is clinically stable and have normal TSH levels with hormone replacement, or patients with vitiligo or psoriasis not requiring treatment remain eligible for the study
Patients with feeding tubes are eligible for the study
Patients with mature teratoma or completely resected immature teratoma with normal tumor markers are not eligible
Newly diagnosed, previously untreated: (1) M0 medulloblastoma with > 1.5 cm^2 residual; (2) M+ medulloblastoma; patients with diffusely anaplastic medulloblastoma are eligible regardless of M-stage or residual tumor\r\n* As of amendment # 2, enrollment of patients with supratentorial PNET has been discontinued\r\n* All patients with M4 disease are not eligible
No prior chemotherapy or radiation therapy is allowed; patients should only have had a biopsy of the primary tumor without an attempt at complete or partial resection; patients will still be eligible if unplanned excision was attempted or accomplished as long as adequate imaging was obtained prior to surgery
Patients with anaplastic medulloblastoma are eligible regardless of M-stage or residual tumor
Patients requiring anticonvulsants known to activate the cytochrome p450 system, in particular anticonvulsants such as phenytoin, carbamazepine, and phenobarbital, are not eligible; benzodiazepines and gabapentin are acceptable
Patients must not be candidates for curative locoregional treatments; patients with recurrent locoregional disease following surgery and/or radiation for who a resection is unacceptably morbid and unlikely to be curative are eligible; patients must be reviewed at the Moffitt Cutaneous Tumor Board prior to enrolling on trial to verify unresectability
Patients with post-obstructive pneumonia are eligible provided they no longer require intravenous antibiotics at registration
Patients must not be eligible for full ablative regimens by the attending physician
Patients receiving nilotinib 200 mg PO BID or a lower dose are not eligible
Parts A and B: Patients who are able to swallow liquid or use a nasogastric or gastrostomy (G) tube are eligible
Patients with multiple, ipsilateral pulmonary nodules (T3 or T4) are eligible if a definitive course of daily fractionated radiation therapy (RT) is planned
History of hemoptysis within 30 days of registration; Note: patients who have minimal bleeding from the mouth, which is clearly not related to a source in the lungs, i.e., surgery such as a non-lung biopsy, are eligible only after good hemostasis has been documented
Newly diagnosed patients may need to be on steroids due to surgery or control of neurologic symptoms; patients on steroids postoperatively or for control of tumor-related edema are eligible, but attempts to keep patients on the lowest dose necessary to control symptoms should be made
Patients must have experienced at least one and at most two relapses prior to study enrollment; patients with primary refractory disease are eligible
Prior chemotherapy:\r\n* Ovarian cancer: patients with no prior PLD exposure are eligible after failure of platinum-containing chemotherapy; no more than 2 prior platinum containing regimens is permitted; dose escalating cohorts only: patients already on PLD are also eligible if they are receiving PLD beyond 3 cycles without prohibitive (i.e. no grade 3 or 4) skin or mucosal toxicities, and showing no progressive disease compared to a computed tomography (CT) scan obtained 2 or more months earlier; these patients are eligible in spite of any progression from baseline determined prematurely (i.e., applicable to those patients who are deemed in their best interest to continue to receive PLD after a CT obtained at 2 or 3 months has shown progression from baseline)\r\n** Breast cancer: patients may have received 0-2 prior chemotherapy regimens for metastatic disease; breast cancer patients may not have received prior PLD, and will not be eligible for the expanded cohort A \r\n** Interval between prior chemotherapy and registration for breast and ovarian cancer; there should be at least a 3 week interval between the last chemotherapy regimen and registration, and the patient should have recovered from acute toxicity related to prior therapy (6 weeks if the last regiment included BCNU or mitomycin C)\r\n** Dose escalating cohorts only: patients will be categorized in the following strata based upon prior PLD exposure: Stratum A –patients with ovarian cancer who have had prior PLD exposure and received at least 3 cycles of PLD without prohibitive (i.e. no grade 3 or 4 skin toxicity) and have not had progressive disease; Stratum B: patients with ovarian or breast cancer who have had no prior PLD exposure
* Phase 1 (Part A3) - COMPLETE: Patients with relapsed or refractory neuroblastoma, with or without bone marrow involvement, who are not eligible for Part A1 or A2 or cannot enroll on Part A1 because of stratum suspension or lack of available slots (these patients will be enrolled at one dose level below the dose level at which patients on Part A1 are actively enrolling)
Patients with a history of an invasive malignancy within the last 3 years are not eligible for the protocol; patients who are no evidence of disease (NED) from a prior invasive malignancy for at least 3 years or longer are eligible for the trial; patients with history of benign tumors such as a pituitary macroadenomas, meningiomas, or craniopharyngiomas are eligible as long as the benign tumor is under local control regardless of the time frame; patients with concurrent adequately treated basal cell or squamous cell carcinoma of the skin are also eligible for the protocol
Patients eligible for any higher priority transplant protocols
Patients with an active or uncontrolled infection. Patients on prolonged antifungal therapy are still eligible if they are culture and biopsy negative in suspected radiographic lesions and meet other organ function criteria.
Tumor Requirements: All Patients must have at least one measurable target extracranial lesion according to RECIST v1.1. In addition patients with asymptomatic CNS metastases (including patients asymptomatic by means of stable or decreasing doses of steroids within the last 2 weeks prior to study entry) will be eligible. Patients who have leptomeningeal disease (LM) or carcinomatous meningitis (CM) are eligible.
Previous treatment with investigational agents that inhibit MDM2 or MDMX activity (some MDM2-treated patients may be eligible)
Eligible for MRI [Form GCP-10131]
Patient must have progressed following 12 months of treatment with MEDI4736; patients who discontinue MEDI4736 prior to the completion of 12 months (for any reason) are not eligible; patients who have already completed two 12-month periods of treatment are not eligible
Patients with high-risk uterine leiomyosarcoma (LMS), Federation of Gynecology and Obstetrics (FIGO) stage I (confined to corpus +/- cervix); patients with known uterine serosa involvement are not eligible; patients should have had, at least, a complete hysterectomy (including removal of the cervix); bilateral salpingo-oophorectomy is not required \r\n* Institutional pathology review calls the uterine leiomyosarcoma “high grade”\r\n* Additionally, if the pathology report indicates a mitotic rate, the mitotic rate should be greater than or equal to 5 mitoses/10 high-power field\r\n* All patients must be no longer than 12 weeks (3 months) from surgical resection of cancer at the time of enrollment on study; if a patient requires a second operation to complete her surgery, i.e., trachelectomy to remove the cervix and/or bilateral salpingo-oophorectomy (BSO), the 12 weeks may be counted from the time of the second operation\r\n* Patients who had a “morcellation” hysterectomy procedure that involved morcellation within the peritoneal cavity are eligible IF a second operation is performed and biopsies from the second procedure show no evidence of leiomyosarcoma
Patients who have received any investigational products, antineoplastic therapies, or radiotherapy within 14 days prior to registration are not eligible; NOTE: patients actively receiving hydroxyurea are eligible and may continue to receive hydroxyurea through cycle 1 of protocol treatment; if the platelet count remains above 1 million after cycle 1, hydroxyurea can be used at the treating physician’s discretion, if the platelets are 1000 x 10^9/L, or more, or if there are symptoms from thrombocytosis
Patients with Gilbert's syndrome uncomplicated by other liver disease may be eligible if agreed upon by the investigator and medical monitor for the sponsor.
Patients who only present with localized disease
Patients whose insurance will not cover proton therapy will still be eligible for the study
Patients with tumors adjacent to a vertebral body are eligible as long as all gross disease can be encompassed in the radiation boost field; the boost volume must be limited to < 50% of the ipsilateral lung volume
B-ALL patients must be enrolled on AALL08B1 or APEC14B1 (if open for the classification of newly diagnosed ALL patients) prior to treatment and enrollment on AALL0932\r\n* Note: B-LLy patients are not eligible for AALL08B1, and can enroll directly onto AALL0932
Patients must have newly diagnosed National Cancer Institute (NCI) Standard Risk B-ALL or B-LLy Murphy stages I or II; patients with Down syndrome are also eligible\r\n* Note: for B-LLy patients with tissue available for flow cytometry, the criterion for diagnosis should be analogous to B-ALL; for tissue processed by other means (i.e. paraffin blocks), the methodology and criteria for immunophenotypic analysis to establish the diagnosis of B-LLy defined by the submitting institution will be accepted
B-ALL patients with testicular leukemia are not eligible for AALL0932
Patients with porphyria are not eligible
Patients with primary spinal cord tumors are eligible. Patients with multi-focal disease within the cerebrum are eligible.
Patients with a diagnosis of oligodendroglioma or oligoastrocytoma are not eligible.
Eligible patients must have appropriate staging studies identifying them as specific subsets of the revised International Association for the Study of Lung Cancer (IASLC) stage IA based on the following combination of Tumor Node Metastasis (TNM) staging: T1a,N0,M0 or T1b,N0,M0
Eligible patients must have histopathologically confirmed myxoid liposarcoma with confirmation of DDIT3 rearrangement
Patients with T1, N0M0 disease are not eligible
Patients with ASM and MCL with or without an AHNMD are required to have at least one of the eligible organ damage findings as defined by the international consensus response criteria
Patients (with skin metastases only) who will be therapeutically anticoagulated with heparins or Coumadin at the time of the biopsy (they are eligible if anticoagulation can be held prior to biopsy as per investigator); patients on aspirin and other platelet agents are eligible
Magnetic resonance imaging (MRI) echocardiogram (ECHO) gradient sequences are required to evaluate for the presence or absence of central nervous system (CNS) hemorrhage; patients with intra-tumoral and/or CNS hemorrhage are not eligible for study entry except:\r\n* Patients with asymptomatic intra-tumoral hemorrhage of punctate size, at the time of diagnosis, after surgery, and/or any time during protocol therapy\r\n* Patients with asymptomatic post-operative hemorrhage in and/or around the surgical cavity are eligible for study entry; additional imaging studies are not required, but in the event a repeat MRI is performed for clinical reasons the post-operative hemorrhage must not have progressed
Patients must be considered unresectable or inoperable. Patients with nodal recurrence after surgery for early-stage NSCLC are eligible if the following criteria are met:
Eligible patient must show evidence of wild-type (WT) p53 as assessed by central DNA sequencing conducted at Dr. Jeffrey Sklar’s laboratory at Yale University Cancer Center; note, that since patients with AML have a rapidly proliferating disease, patient can be enrolled and begin treatment prior to obtaining the results of this test; patients who are found to the TP53 mutated will be removed from study and can continue on single agent decitabine; however patients will continue to be followed for toxicity
Is not eligible or has refused any protocols of higher priority
Patients receiving cyclosporine A, tacrolimus, or sirolimus are not eligible for this study.
Patients of childbearing potential, not practicing adequate contraception, patients who are pregnant, or patients who are breastfeeding are not eligible for this trial.
Patients receiving a haploidentical / T cell-depleted transplant are eligible to follow a modified treatment plan that does not include withdrawal of immunosuppression
Patients who have received Gliadel wafers or alternating electrical field therapy are not eligible for this study
Histologic evidence of angiolymphatic invasion (ALI); Note: Cases termed focally suspicious for ALI but where no definitive ALI is found are eligible
Patients with radiation-associated gliomas will not be eligible
Patients with a history of non-central line related thrombosis, more than one prior central-line related thrombosis, or known coagulopathy will not be eligible; patients with a first degree family member with a known coagulopathy will be excluded, and therefore, obtaining a family history is essential when possible; patients actively on anticoagulation therapy are not eligible
A survivor of prior cancer is eligible provided that ALL of the following criteria are met and documented:
Patients must not be eligible for a higher priority (e.g.; phase II/III), National Surgical Adjuvant Breast and Bowel Project, Radiation Therapy Oncology Group, and Gynecologic Oncology Group (NRG) protocol for the same population if one exists
Patients with nasopharyngeal carcinoma are not eligible
Patients with cancer are eligible provided they meet the specifications
Must be off prior systemic therapies for 2 weeks prior to enrollment; patients that have been previously treated with systemic therapy adjuvantly or for metastatic disease remain eligible as long as they continue to meet all other eligibility criteria (oligometastatic, no visceral metastasis > 5 cm, eligible for SABR)
Patients with second malignancies may be eligible at discretion of principal investigator (PI) given acute life threatening nature of untreated AML or higher risk MDS; patients maintained on long-term non-chemotherapy treatment, e.g., hormonal therapy, are also eligible
Patients who have received yttrium-90 microspheres are not eligible
Due to risk of disease exacerbation patients with porphyria are not eligible
Patients with NF (neurofibromatosis) are eligible, and may have other stable central nervous system (CNS) tumors, such as schwannoma, acoustic neuroma, or ependymoma, but ONLY if these lesions have been stable in size for the preceding 6 months
All patients must be eligible to have either IMRT or IMPT as determined by the study radiation oncologist
Patients with multifocal or multicentric disease are eligible as long as each tumor individually meets eligibility criteria; central confirmation is needed for any site of disease that is tested to be HER2-positive by local testing (unless testing was done by Clarient)
Patients with any intercurrent organ damage or medical problems that would prohibit therapy are NOT eligible for participation
Prior therapy\r\n* Patients with prior exposure to brentuximab vedotin are not eligible; NOTE: prior exposure to gemcitabine is NOT an exclusion criterion\r\n* Patients who have undergone prior autologous or allogeneic SCT are not eligible\r\n* Patients with HL who were stage IA or IIA at initial diagnosis and treated with either radiation alone or < 4 cycles of chemotherapy are not eligible
Disease confined to the intraperitoneal and retroperitoneal cavity; Note: nodal disease below the diaphragm, implants adherent to the surface of the liver or intrahepatic lesions will not be exclusionary; patients remain eligible if all intrahepatic tumor is debulked or ablated by the time treatment is initiated
Patients who are receiving concomitant D2-antagonists (such as phenothiazines, butyrophenones, thioxanthenes, or metoclopramide) are NOT eligible for participation; patients must be off any such medications by the time of registration
Patients with second malignancies in remission may be eligible if there is clinical evidence of disease stability for a period of greater than 6 months off cytotoxic chemotherapy, documented by imaging, tumor marker studies, etc., at screening. Patients maintained on long-term non-chemotherapy treatment, e.g., hormonal therapy, are eligible.
Patients who have received prior locoregional therapy for metastatic disease including surgical resection, microwave ablation, cytoreductive surgery with hyperthermic intraperitoneal chemotherapy, or radiation are eligible providing the measurable disease is clearly manifest and is outside of the radiation port or ablation field; patients who have received liver directed treatments such as yttrium-90 radioembolization or transarterial chemoembolization are eligible if their measurable disease is outside of the liver
Criteria that need to be met to participate in this study:\n\n          -  Patients must be > 12 months and < 30 years of age when registered on study.\n\n          -  Patients must have relapsed neuroblastoma, refractory neuroblastoma that had less than\n             a partial response to standard treatment or persistent neuroblastoma that had at least\n             a partial response to standard treatment. All patients must have at least ONE site of\n             evaluable disease.\n\n             o Patients who have at least a partial response to standard treatment who still have\n             neuroblastoma that can be seen on CT/MRI or MIBG scans must have a surgical biopsy\n             done of the tumor to confirm that it is neuroblastoma. Patients with relapsed or\n             refractory neuroblastoma do not need to have a biopsy done to enter on study.\n\n          -  Patients must have adequate heart, kidney, liver and bone marrow function. Patients\n             who have bone marrow disease must still have adequate bone marrow function to enter\n             the study.\n\n          -  MLN8237 must be swallowed as whole tablets. Therefore, patients must be able to\n             swallow pills to be eligible for study. One tablet is the size of small breath mint,\n             or baby aspirin. Due to the size of MLN8237 tablets, patients must have a body surface\n             area of at least 0.38 m2 to be eligible for study. A body surface area is a\n             combination of a patient's height and weight. An example of a child with a BSA of 0.45\n             is a child that is 25 inches tall and weighs 25 pounds.You can use the link below to\n             calculate your child's body surface area and determine if they are too small for this\n             trial.\n\n        Patients cannot participate in the study if:\n\n          -  Patients who have received prior MLN8237 are excluded from all phases of the study.\n             Patients previously treated with irinotecan and/or temozolomide will be eligible if\n             they have not had documented progressive disease during treatment with a regimen\n             containing these agents.\n\n          -  They have other medical problems that could get much worse if they had this treatment.\n\n          -  They are on dialysis for bad kidney function.\n\n          -  They are pregnant or breast feeding.\n\n          -  They have active infections such as hepatitis or fungal infections.\n\n          -  They have an allergy to treatment with cefixime and cefpodixime.\n\n          -  They have brain metastasis at study entry, or have received cranial spinal radiation.\n\n          -  They have had an allogeneic stem cell transplant (received stem cell from someone\n             else).\n\n          -  They can't cooperate with the special precautions that are needed for this trial.
Patients must discontinue antiandrogen therapy for at least 4 weeks (e.g. flutamide, bicalutamide, nilutamide) prior to registration with no evidence of a falling PSA after washout; patients on steroids are eligible as long as they will be switched to prednisone
Patients with a history of thromboembolism unrelated to a central line, or patients with a known predisposition syndrome for thromboembolism are not eligible
Both KRAS wild type and KRAS mutant patients are eligible
Patients scheduled to undergo laparotomy *Both optimal and suboptimal patients will be eligible for the study (Suboptimal patients, as well as those who undergo only exploratory laparotomy, are eligible.)
Individuals who do not meet criteria for cohort 1 (progressive disease) or cohort 2 (eligible for surgery) are not eligible for enrollment (i.e. patients with previously untreated disease that is not amenable/planned for surgical resection are not eligible)
Patients with a prior malignancy will NOT be eligible for participation aside from the following exception:\r\n* Patients who have had any curatively treated malignancy and have been disease free without treatment for 1 year prior to study entry ARE eligible for participation
Asymptomatic patients
Patients must not have any disease that will obscure toxicity or dangerously alter drug metabolism; patients with a history of psychosis/schizophrenia or cardiac disease requiring beta-blocker treatment (unable to change medication to non-beta blocker), anti-malarial drugs, or quinine or quinidine will not be eligible for enrollment to a mefloquine containing arm; patients who are on active treatment with one of the study drugs at the time of evaluation will not be eligible for enrollment to an arm containing that study drug
History of prior Lupron intolerance; Note: patients ARE eligible if prior or current Lupron exposure
Patients with uncontrolled diabetes mellitus or a fasting plasma glucose > 1.5 ULN; note: optimal glycemic control should be achieved before starting trial therapy; at the principal investigator’s discretion, non-eligible patients can be re-screened after adequate medical therapy has been instituted
Patients with psoriasis
Patients consuming >= 6 servings per day of fruits and vegetables (not including juices), as determined by the run-in dietary recalls, are not eligible
Patients with a history of central nervous system metastasis are allowed provided they have been treated (surgery, radiation, or radiosurgery) at least 4 weeks prior to initiating study drug and do not require medication(s) to control symptoms; patients with known leptomeningeal disease are not eligible
Patients must have progressed after at least one prior systemic therapy for GCT and meet one of the following criteria:\r\n* Patients with evidence of progressive or recurrent GCT after progression prior high dose chemotherapy (HDCT) treatment, defined as meeting at least one of the following criteria:\r\n** Tumor biopsy of new or growing or unresectable lesions demonstrating viable GCT; in the event of an incomplete gross resection where viable GCT is found, patients will be considered eligible for this 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 rise\r\n* Patients deemed not to be a candidate for or benefit from potentially curative HDCT or other curative treatment options defined as follows:\r\n** Patients with inadequate renal function for HDCT\r\n** Patients who have had 3 or more lines of prior chemotherapy\r\n** Patients with late relapse (relapse > 2 years after last therapy)\r\n** Patient with inadequate stem cell collection to move forward with HDCT\r\n** Patients with significant medical or psychosocial comorbidities that are felt to be a contraindication to HDCT by the treating investigator\r\n* NOTE: There is no maximum number of prior treatments allowed\r\n* NOTE: Patients with clinically growing \teratoma\ (normal declining tumor markers and radiographic or clinical progression) should be considered for surgery; in patients with rising tumor markers as their only evidence of disease progression where AFP is < 30 or HCG is < 15, alternate causes of increased levels of these markers should be ruled out; (e.g., hypogonadism by testosterone suppression of luteinizing hormone [LH], hepatitis, use of marijuana)
Participants with splenic MZL who do not meet the radiographically measurable disease criteria described herein are eligible for participation provided that bone marrow infiltration of MZL is histologically confirmed.
Patients with contralateral mediastinal disease (N3) are eligible if all gross disease can be encompassed in the radiation boost field in accordance with the heterogeneity criteria; patients with superior sulcus tumors, or scalene, supraclavicular, or contralateral hilar node involvement, will be eligible if the RT treatment plan allows the dose to the critical structures to be within the tolerance limits (e.g. the dose per fraction can be changed to 1.8Gy for the lymph nodes and 2 Gy per fraction for the primary tumor) while keeping total dose to 60 Gy
Patients with a creatinine greater than 2.5 times the upper limit of normal are eligible, but will be told that they are at greater risk for kidney damage that could possibly result in temporary or even permanent dialysis
Patients may have had up to 2 prior relapses.
Patients must not have: a) active infection; b) disease that will obscure toxicity or dangerously alter drug metabolism, especially liver disease; c) serious intercurrent medical illness; d) prior treatment with HDAC inhibitors. However, patients who have received anticancer agents for non-therapeutic purposes (for eg., as part of a pharmacology study without therapeutic intent) will remain eligible for enrollment into the study.
Treatment with hydroxyurea, busulfan, cytoreductive agents other than frontline TKI, or an investigational agent within 28 days of registration; patients who are on alpha-interferon as primary therapy are not eligible
Patients with evidence of disease are only eligible if the disease is stable (or persistent) in comparison to the status prior to transplantation
Transplant eligible patients are eligible
Patient's ALT and AST must be < 5 x institutional upper limit of norm ULN. The hepatic requirements are waived for patients with known or suspected liver involvement who would otherwise be eligible after consultation with the Study Chair or Vice Chair.
Patients with psoriasis
Patients with cytogenetic breakpoint cluster region (BCR)-Abl variants and additional chromosomal abnormalities (‘clonal evolution’) will be eligible; cytogenetics to be performed, but results are not required to start therapy in patients with hematologic progression
Patients with any tumor (T) with node (N)2 or N3 are eligible; patients with T3, N1-N3 disease are eligible if deemed unresectable; patients with T4, any N are eligible
SCREENING: Patients with clinically evident or histologically proven sarcomas, melanomas, germ cell tumors, or epithelial malignancies metastatic to the lungs, mediastinum, or pleura who can be rendered no evidence of active disease (NED) following standard surgical therapy; note: patients with active disease outside the thorax may be eligible for the study once the extrathoracic disease is definitively treated by local modalities such as radiation, surgery, or radiofrequency ablation
SCREENING: Patients with no more than 3 intracranial metastases, which have been definitively treated by surgery or radiation therapy may be eligible for study provided there is no evidence of active disease for at least 2 months
RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Patients with progressive DIPG, as defined by progressive neurologic abnormalities or worsening neurologic status not explained by causes unrelated to tumor progression (e.g., anticonvulsant or corticosteroid toxicity wean, electrolyte disturbances, sepsis, hyperglycemia, etc.), OR an increase in the bi-dimensional measurement, taking as a reference the smallest disease measurement recorded since diagnosis, OR the appearance of a new tumor lesion since diagnosis\r\n* Please note: patients with a radiographically typical DIPG, defined as a tumor with a pontine epicenter and diffuse involvement of more than 2/3 of the pons, are eligible without histologic confirmation\r\n* Patients with pontine lesions that do not meet these radiographic criteria will be eligible if there is histologic confirmation of malignant glioma World Health Organization (WHO) II-IV
For Part 2 and 3, all patients must have an FGF19 IHC result available. Only FGF19 IHC+ HCC patients will be eligible for Part 3.
History of (within 24 months prior to enrollment) of kidney, ureter, or bladder stones with clinically significant sequelae (e.g. (painless gross hematuria; pain with or without infection; hydronephrosis, etc); patients with otherwise stable non-occluding kidney stones regardless of stone type incidentally found in computed tomography (CT) scans are eligible; patients with prior history of uric acid stones are eligible regardless of time of onset
Minimal residual disease (MRD) will be defined separately for each test (fluorescence-activated cell sorting [FACS], FISH or cytogenetics) using standard accepted definitions (that may change over the course of this study and are therefore not listed); thus, patients will be considered eligible only in cases where residual leukemia (i.e., MRD) can be detected above control values; in cases where MRD testing is not conclusive or when there is no control value for the test, the attending pathologist will be engaged and patients will only be eligible in cases where there is clear evidence of MRD
Patients who are immunologically compromised (excluding corticosteroids used for control of tumoral edema) are not eligible
Having chronic hepatitis B or C will not exclude patients from participating if they are otherwise eligible; however, requiring treatment with interferon is an exclusion; patients must be stable without having received interferon in at least 4 weeks
All stages of cancer are eligible
Patients who have an active or uncontrolled infection are not eligible; patients on prolonged antifungal therapy are still eligible if they are culture and biopsy negative in suspected radiographic lesions and meet other organ function criteria
Patients must be eligible for Alliance A031201 and must agree to proceed to enroll in A031201
For dose expansion cohorts: Dose expansion portion of study will include two separate cohorts\r\n* One cohort will incorporate patients with esophageal, gastroesophageal junction (GEJ) or gastric carcinomas (squamous cell carcinoma or adenocarcinoma if predominant histology); these patients must have received at least one prior systemic therapy for metastatic disease; patients who had prior neoadjuvant or adjuvant chemotherapy as part of curative intent primary therapy but recurred in less than 6 months would also be eligible; patients with HER2+ disease must have received trastuzumab with disease progression prior to enrollment; patients on this arm may have had prior treatment with drugs targeting the PD-1 pathway, but will be limited to a maximum of 5 patients\r\n* The second cohort will include patients who have progressed on prior PD-1 pathway inhibition (single agent or in combination) in solid tumor types where these drugs are standard of care; the reason for discontinuation of the prior PD-1 pathway drug must not have been for toxicity; eligible tumor types include melanoma, RCC, UC, NSCLC, and SCCHN, but subsequent tumor types wherein relevant agents become an approved standard of care would also become eligible
Patients with second malignancies in remission may be eligible if there is clinical evidence of disease stability for a period of greater than 6 months off cytotoxic chemotherapy, documented by imaging, tumor marker studies, etc., at screening. Patients maintained on long-term non-chemotherapy treatment, e.g., hormonal therapy, are eligible.
Patients eligible for participation in Study CLTR0310-301 (Phase III study of CPX-351 NCT01696084) or who have already participated in that study are not eligible for this study.
Patients must have received crizotinib monotherapy at 250 mg BID on a continuous dosing schedule for at least 90 days; patients must be planning to start treatment at least three days, but no more than 30 days after discontinuing crizotinib monotherapy; patients who were not able to tolerate 250 mg BID of crizotinib are not eligible for this study
Patients taking the following medications may experience QT/QTc interval prolongation and are not eligible for the trial - most anti-arrhythmia drugs (incl. amiodarone), erythromycin, quinolone antibiotics, ketoconazole, Zithromax, and phenothiazine and will be denied enrollment in the study. The possible interactions of these drugs and DM-CHOC-PEN have not been established. Patients receiving these drug will only be eligible if they discontinue the drugs and have an acceptable ECG.
Patients with cutaneous disease only are not eligible
Patients presenting with untreated cord compression, visceral metastases or those in need of immediate treatment are not eligible (patients with prior treatment and stability will be eligible)
Only patients with a test result, using the 5-gene Hh signature assay, indicating Hhpathway activated MB are eligible for this study. All available tumor material obtained at any time during the course of the patient's disease should be submitted for these analyses
Patients who have an active or uncontrolled infection are excluded. Patients on prolonged antifungal therapy are still eligible if they are culture and biopsy negative in suspected radiographic lesions and meet other organ function criteria.
Patients with prior allogeneic transplant are not eligible.Patients with a documented history of cerebrovascular accidents and/or TIA within the past 6 months are not eligible.
Patients who have recurrent hepatocellular carcinoma following hepatic transplantation are excluded unless the following criteria are met: i. Transplantation was performed at least 6 months prior to the relapse of HCC. ii. Patients are on stable immune suppressive therapy with no clinical evidence of rejection. iii. Are receiving ? 2.5 mg everolimus daily. d. Patients with known HIV infection are excluded. e. Patients with Hepatitis B are eligible provided there is no active viral replication. Patients with Hepatitis C who are not on interferon are eligible.
Not eligible for or declined transplantation or any standard therapy known to be life prolonging or life saving
Cohort A: Stage IIA-IIIA (TanyN1M0 or T2b-4N0M0) (selected patients with single station N2 nodal involvement in close proximity to the primary tumor target may be considered eligible at the discretion of the principal investigator [PI] if all normal tissue guidelines can be met)
Patients with no prior therapy are eligible, provided they have metastatic disease that is not curable by surgery
Adult patients
Patients must not have had disease progression while receiving siltuximab. For those patients originally assigned to placebo in the CNTO328MCD2001 study, patients who have received less than 4 months of siltuximab following crossover will also be eligible
Patients who are eligible for HSCT but with non-optimal AML disease control (i.e., blasts > 5%) may be enrolled into this study as a bridge-to-transplant.
Eligible diagnoses:
Patients with a fasting plasma glucose > 1.5 ULN; Note: at the principle investigator’s discretion, non-eligible patients can be re-screened after adequate medical therapy has been instituted
Patients that are 12-18 months of age with INSS stage 4 and all 3 favorable biologic features (i.e., non-amplified MYCN, favorable pathology, and DNA index > 1) are not eligible
Patients with current diagnosis of primary cutaneous ALCL (patients who have transformed to systemic ALCL are eligible).
Patients that are not willing to adhere to the photosensitivity guidelines will not be eligible
Patient with suspected recurrence of osteosarcoma but who has not had surgery is eligible for enrollment but will not be randomized to receive study medication until deemed fully eligible following surgical removal of all lung nodules.
All patients must have CTCL diagnosed by morphologic, histochemical or cell surface marker criteria with stage never exceeding IB / IIB disease and mSWAT < 50%. CTCL patients with stage IA disease are not eligible for enrollment. CTCL patients with stage IB disease are eligible provided that they have failed a systemic treatment (this includes radiation). CTCL patients with bone marrow involvement but without lymph node involvement are eligible. Patients with a diagnosis of angioimmunoblastic T cell lymphoma are eligible, even with lymph node involvement. Age ? 18 years. Patients must have a performance status of < 2 on Eastern Cooperative Oncology Group scale (see Appendix). Patients must have fully recovered from toxicity of prior chemotherapy or radiation therapy.
Wilm's tumor and clear cell sarcoma\r\n * Patients with Wilm’s tumor or clear cell sarcoma will be eligible if relapse occurs following an autologous transplant or if the patient relapses following initial treatment, but is not eligible for an autologous transplant; patients who do not achieve a CR with initial therapy will also be eligible provided they can be rendered free of bulky disease as defined above
Neuroblastoma\r\n * Neuroblastoma patients will be eligible if relapse occurs following an autologous transplant or if the patient relapses following initial treatment, but is not eligible for an autologous transplant\r\n * Patients who do not achieve a CR with initial therapy will also be eligible provided they can be rendered free of bulky disease as defined above
Hodgkin disease (HD)\r\n * Patients with HD will be eligible if they fail to achieve a CR following conventional therapy\r\n * Patients who relapse following conventional therapy, but fail to achieve a second CR (or for any other reason cannot undergo autologous transplantation) will be eligible\r\n * Patients who relapse after an autologous transplant will be eligible
Patients with second malignancies in remission may be eligible if there is clinical evidence of disease stability for a period of greater than 6 months off cytotoxic chemotherapy, documented by imaging, tumor marker studies, etc., at screening. Patients maintained on long-term nonchemotherapy treatment, e.g., hormonal therapy, are eligible.
Patients with active disease outside the thorax may be eligible for study once the extrathoracic disease is definitively treated by local modalities such as radiation, surgery, or radiofrequency ablation
Patients with prior exposure to agents targeting interleukin 6 (IL -6) or the IL-6 receptor are not eligible
Patients with a motor, visual, or auditory handicap that prevents computer use (e.g., unresolved posterior fossa syndrome) are not eligible to participate in this trial
Patients with full-scale intelligence quotient (IQ) < 70 per previous testing OR existing diagnosis of/educational classification as a student with an intellectual disability are not eligible
People who are on long-term (> 1 year) chronic treatment are eligible
Patients on immunosuppression are also eligible
Patients with prior treatment with IFN-gamma will be eligible, if they previously tolerated IFN-gamma, however patients must be off of IFN-gamma for at least three weeks before initiation of therapy on this trial
Patients with a prior diagnosis of hand-foot skin reaction are not eligible.
All ethnicities eligible
Patients having no reconstruction are eligible for the study
Patients must be eligible for epidural placement
Treatable causes of fatigue have not been ruled out, at least by history and exam criteria, by the treating provider, such as uncontrolled pain, hypothyroidism, or insomnia; NOTE: if these are considered to be the primary cause for the patient’s fatigue then the patient is not eligible for this trial
Patients with paranasal sinus or nasopharyngeal carcinoma who are about to undergo radiation therapy; patients with paranasal sinus or nasopharyngeal carcinoma who have completed radiation therapy 3-6 months prior to enrollment who then show olfactory loss on a screening test (University of Pennsylvania Smell Identification Test [UPSIT] – score of 34 or 33 or lower out of 40, depending on female/male); both those patients undergoing chemotherapy and those who did not will be eligible, and this factor will be assessed as a possible confounder/contributor in a multi-regression analysis
Patients with a documented history of invasive fungal infection (IFI) within the previous 30 days are not eligible
Patients receiving treatment for an IFI are not eligible
Patients across all stages of disease
Patients must have a firm diagnosis of cGvHD, in accordance with National Institutes of Health (NIH) guidelines; patients with “overlap syndrome” are also eligible, but patients with recurrent, late onset and/or persistent acute GvHD (alone) are not eligible
Patients receiving treatment for an IFI are not eligible
Patients with history of liver transplantation may be eligible for the dose expansion cohorts (parts 2A and 2B) of this study provided all eligibility criteria are met and provided the subject has not had any episodes of acute rejection or serious opportunistic infection within 3 months from enrollment\r\n* Certain immunosuppressive agents such as tacrolimus and sirolimus are prohibited thus liver transplant patients who require these medications for immunosuppression are not eligible\r\n* Patients receiving everolimus at immunosuppressive dosages are eligible
Patients with fasting serum triglycerides > 300 and/or with hypertriglyceridemia requiring medication (but not patients with hypercholesterolemia: patients with hypercholesterolemia with or without medication are eligible).
An international normalized ratio (INR) =< 1.5 (patients who are therapeutically anticoagulated for unrelated medical conditions such as atrial fibrillation and whose antithrombotic treatment can be withheld for operation will be eligible)
Arm C1 and C2: SCNSL patients do not require one prior CNS directed treatment; newly diagnosed SCNSL patients are eligible as long as their systemic disease has been treated and does not require any active treatment
Patients must have histologically or cytologically confirmed solid tumor or heme malignancy; exceptions include patients with pancreatic cancer or colon cancer who are receiving oxaliplatin and are thus eligible for Comprehensive Cancer Center of Wake Forest University (CCCWFU) 98112; patients undergoing inpatient induction therapy for acute leukemia; and those hospitalized for marrow or peripheral blood stem cell transplantation
Patients for whom there is only one good surgical option or any other clinical/nonclinical reason for which the surgeon determines the patient is not eligible for the study
Patients who are not eligible to receive SCT with cyclophosphamide and total body irradiation (TBI) conditioning because they do not meet transplant criteria are also not eligible for this phenylephrine study
General exclusion criteria for transplant include:\r\n* Patients who have angina and/or congestive heart failure requiring treatment, or who have had a myocardial infarction within the past year\r\n* Patients who have had any complication that makes the risk of death during transplantation from non-malignant causes greater than the risk of relapse\r\n* Patients who have any active infection; if the infection is successfully treated, the patient may be reconsidered for transplantation at a later date\r\n* Patients with diabetes who are not controlled by medical management will be ineligible\r\n* Psychiatric illness requiring psychiatric counseling or medical intervention other than antidepressant medications may make an individual ineligible and will be considered on a case-by-case basis\r\n* Psychosocial assessment by the bone marrow transplant team may identify individuals for whom this form of therapy may be contraindicated; these decisions will be based upon estimated adequacy of patient support systems and prediction of patient’s compliance with medications, required diagnostic procedures, and/or follow-up care\r\n* Patients who have an ECOG performance status of greater than 2\r\n* Patients who have decreased pulmonary function due to any disorder as demonstrated by a diffusion capacity of less than 50% of predicted, a FEV1 of less than 60% of predicted, or a PO2 of less than 80mmHg on pulmonary function testing\r\n* Patients who have a resting ejection fraction of less than 50%\r\n* Patients who have renal disease as demonstrated by a serum creatinine clearance of greater than 2.0 mg/dL and/or a creatinine clearance of less than 50 mL/min\r\n* Patients who are pregnant or breast feeding at the time of admission for conditioning
Patients with tumors adjacent to a vertebral body are eligible as long as all gross disease can be encompassed in the radiation boost field; the boost volume must be limited to < 50% of the ipsilateral lung volume
Both heterosexual and same sex couples will be eligible
All diagnoses will be eligible
Patients who have had local genotyping are eligible, regardless of the local result
Individuals who are cognitively impaired are eligible for the study and consent for participation must be given by a legal authorized representative or parent; pregnant women are eligible for the study
Women who are regularly screened for cervical cancer are not eligible
Individuals with a history of natural or artificial sun exposure to the buttocks within 30 days of study participation are not eligible
Eligible for state quitline services
Women with an intact cervix (patients who have undergone previous loop electrosurgical excision procedure [LEEP], cone and/or cryotherapy are eligible)
Sexually active women of all ethnicities and races with an intact cervix are eligible for this trial
Drugs that interfere with mitochondrial function if they are unable to be discontinued 48 hours prior to 13MBT testing will be excluded for this test only but eligible for the rest of the protocol
Patients will have to undergo mutational testing for Isocitrate dehydrogenase 1 (IDH1) on a tumor specimen before entering study. Patients are eligible for Arm C regardless of their IDH1 mutational status.
Patient not eligible for sequential MRI evaluations are not eligible for this study.
Patients who have multicentric disease
Patients with solid tumors with diagnoses OTHER than neuroblastoma or those listed above will be eligible if they meet both of the following criteria:\r\n* Immunohistochemical demonstration of GD2 expression on cell surface (tumor assessment by immunohistochemistry is required for this group of patients)\r\n* Have refractory or relapsed disease or metastatic disease
250 consecutive consenting patients presenting to The Ohio State University College of Dentistry for routing dental care will be recruited; adult patients presenting to the screening clinic for initial oral evaluation will be eligible to participate
Patients will be eligible for this study regardless of prior treatment, as long as they meet other eligibility criteria; therefore, patients who are newly diagnosed, post-operative, post-radiation or post-chemotherapy are eligible
Patients who are excluded from 7T MR imaging because of titanium implants that are not yet established to be safe at 7T remain eligible for the imaging at 3T
Patients with cT2N1-3M0 or cT2-4NxM0 will be considered eligible for participation
Patients with thoracic disease to be treated using radiotherapy will be eligible for this study
ADULT PATIENTS:
Cannot eat normal table food by mouth; NOTE: patients with any form of feeding tube or a swallowing disorder are not eligible
Have taken fish oil, another dedicated n-3 supplement, or SH seed from another source within the last 28 days; patients on multivitamins that contain n-3 are eligible
Patients will be excluded if physicians/staff determine they will not be eligible for a trial during the study period (e.g., entering hospice; moving away)
All diseases that are indications for allogeneic BMT at Stanford University will be eligible for participation in this study
No limitations on prior therapy for eligibility; eligible patients must be receiving their first allogeneic BMT
Consent both to provide data themselves and to assist in identifying eligible patients for recruitment to the trial
While we are focusing on recruitment of clinicians who treat breast, prostate, or colorectal cancers, any eligible patients of the clinicians (e.g., a testicular cancer patient) will be approached for potential participation in the study
Patients are eligible if they have been in stable dasatinib induced CMR for a minimum of nine months, documented by at least three assessments, conducted 2 - 6.5 months apart, at a local lab.
Additional Criteria for Patients Eligible to Restart Dasatinib
Patients are eligible to be treated with RT or CRT and plan to start treatment