Patients must be enrolled on ANBL00B1 or APEC14B1 prior to enrollment on ANBL1531
Part A2: Patients must be >= 6 months and < 12 months of age at the time of study enrollment; patients will enroll one dose level behind the dose level at which patients in Part A1 are enrolling
Prior enrollment in an enfortumab vedotin study or prior treatment with other monomethyl auristatin E (MMAE)-based antibody-drug conjugates (ADCs).
Patients must be enrolled on AALL08B1 or APEC14B1 (if available for ALL patients) prior to enrollment on AALL1131
Infants must be > 36 weeks gestational age at the time of enrollment
Patients with known absence of KMT2A-rearrangement leukemia prior to enrollment
Subjects may receive palliative radiotherapy for symptomatic metastases prior to enrollment provided that there is at least one other non-irradiated lesion amenable to LCT at the time of enrollment.
For patients enrolled on AALL08B1 or APEC14B1 (if open for ALL patients) prior to enrollment on AALL1631, the required diagnostic bone marrow sample has been fulfilled\r\n* For patients who have not previously enrolled on AALL08B1 or APEC14B1 (if open for ALL patients) prior to enrollment on AALL1631, a baseline diagnostic sample must be available to develop an MRD probe\r\n* In addition, laboratory reports detailing evidence of BCR-ABL1 fusion must be submitted for rapid central review within 72 hours of study enrollment
Patients who are known to be experiencing an objective partial response to immunotherapy at the time of study enrollment
Participants must have a lumbar puncture with negative cerebral spinal fluid cytology within 4 weeks prior to enrollment
The FHCRC PI of the study must approve of enrollment of all patients with pulmonary nodules
Patients who have received systemic interferon (IFN)? within the previous 6 months prior to enrollment to the study.
PRIOR TO STUDY ENROLLMENT
Patients must be off all colony- forming growth factor(s) for at least 1 week prior to enrollment (i.e. filgrastim, sargramostim or erythropoietin); 2 weeks must have elapsed if patients received long-acting formulations
Major surgical procedures not permitted </=28 days prior to enrollment. Surgery requiring local/epidural anesthesia must be completed at least 72 hours before enrollment. In all cases the patient must be sufficiently recovered and stable before treatment administration
Received more than 30 Gy of radiation in the thoracic region within 26 weeks prior to study enrollment
Clinical or radiologic suspicion of residual MCC at the time of enrollment
Ocular surface disease at the time of enrollment
Existing significant autoimmune conditions; patients with a history of Hashimoto thyroiditis who are stable on replacement hormone therapy are not excluded; patients cannot be on long-term (> 4 weeks) corticosteroids at doses exceeding prednisone 20 mg (or its equivalent) prior to enrollment; short-term corticosteroid dosing is permitted as long as steroids are discontinued within 2 weeks of study enrollment
Interferon, everolimus (mTOR-inhibitors), sunitinib or other systemic therapies within 4 weeks prior to enrollment; bevacizumab within 6 weeks prior to enrollment
Any liver directed treatment (surgery, radioembolization, chemoembolization, chemotherapy and radiofrequency ablation) within 12 weeks prior to enrollment
Prior Therapies:\r\n* There is no maximum number of prior medical therapies\r\n* There must be no curative or life prolonging treatments available\r\n* Patients who have received other IGF-1R antibodies or inhibitors are eligible, as long as an appropriate washout period has elapsed \r\n* Participants must have had their last fraction of external beam radiation therapy that is local and palliative at least 2 weeks prior to enrollment, and had their last substantial bone marrow radiation at least 6 weeks prior to enrollment\r\n* Participants must have had their last dose of temozolomide at least 4 weeks prior to enrollment; their last dose of other cytotoxic chemotherapy at least 3 weeks prior to enrollment; their last dose of biological therapy, such as biological response modifiers (e.g., cytokines), immunomodulatory agents, vaccines, differentiating agents, used to treat their cancer at least 7 days prior to enrollment, their last dose of a monoclonal antibody at least 3 half-lives prior to enrollment, and their last dose of any investigational agent at least 4 weeks prior to enrollment\r\n* Participants must have recovered from the acute toxic effects of prior therapy to a grade 1 (Common Terminology Criteria for Adverse Events [CTCAE] version [v.]4.0) level prior to enrollment (does not apply to alopecia)
Clinical trials prior to enrollment are allowed, as long as no brain directed therapy was included (current treatment trials are exclusionary)
Therapy with any azole antifungals (e.g., itraconazole, ketaconazole, voriconazole) at the time of enrollment
Patients with primary plasma cell leukemia in VGPR or better at the time of enrollment with no prior disease progression and within 18 months prior to initiation of anti-myeloma therapy which may include single or planned tandem autologous transplant .
Patients must have at least 14 days to recover from all prior treatment, including surgery, chemotherapy, immunotherapies, prior to enrollment on this protocol
Cholangitis that required treatment or intervention within 4 weeks of study enrollment
alemtuzumab within 6 months of enrollment
other lymphotoxic chemotherapy (including steroids except as below) within 2 weeks of enrollment
Active gastrointestinal bleed within 2 weeks of study enrollment
Treatment with the modified Atkins diet (MAD) for any cause within the 9 months prior to study enrollment
Patients must be either intolerant or refractory to one or more standard line(s) of chemotherapy treatment prior to enrollment; toxicity from prior regimens must be resolved to less than or equal to grade 1 prior to enrollment; patients with grade 2 neurotoxicity may be enrolled on a case by case basis at the discretion of the principal investigator; patients should be off all treatment for at least 4 weeks prior to trial enrollment
All conditions associated with significant necrosis of nontumor-bearing tissues: esophageal or gastroduodenal ulcers < 6 months prior to enrollment, organ infarction < 6 months prior to enrollment, or active ischemic bowel disease
Patients with prior investigational drug, chemotherapy, immunotherapy or any prior radiotherapy (except for palliative bone directed therapy) within the past 28 days prior to enrollment, except if the investigator has assessed that all residual treatment-related toxicities have resolved or are minimal and feel the patient is otherwise suitable for enrollment
Platelets < 75,000 cell/mm^3 (75 x 10^9/L). Qualifying laboratory value must occur at most recent measurement before enrollment and must be no more than 14 days before enrollment. No transfusions are allowed within 72 hours prior to study drug administration
Hemoglobin < 8 g/dL. Qualifying laboratory value must occur at most recent measurement before enrollment and must be no more than 14 days before enrollment. No transfusions are allowed within 72 hours before qualifying laboratory value
Kyphoplasty or vertebroplasty within 1 week of enrollment
Treatment with plasmapheresis within 4 weeks before enrollment
No evidence of malignancy at the time of enrollment
Receiving stable-­dose somatostatin analog (long-­acting release [LAR], depot) for > 3 months before enrollment
Off all mycosis fungoides (MF)-directed therapy at the time of enrollment, with the exception of ruxolitinib
Pregnancy at the time of enrollment
Packed red blood cell transfusions or erythropoietin therapy within 14 days prior to the study enrollment unless erythropoietin therapy has been used to maintain a stable condition for at least 1 month prior to the enrollment
Has an adequate treatment washout period prior to enrollment
Patients who are receiving or are planned to start topical chemotherapeutics, retinoids or imiquimod to other lesions that are not planned for enrollment are eligible; however, the lesion being considered for enrollment should not be under active therapy with these topical agents immediately prior to enrollment.\r\n* Use of topical chemotherapeutics, retinoids or imiquimod on the lesion that is a candidate for enrollment must be halted at least 24 hours prior to enrollment in the study.
Subjects may receive radiotherapy for symptomatic metastases prior to enrollment provided that there is at least one other non-irradiated lesion amenable to LCT at the time of enrollment. When feasible, stereotactic body radiation therapy (SBRT) or other hypofractionated techniques are strongly encouraged.
Salvage chemotherapy including TKIs for Ph+ ALL within 1 week prior to enrollment
No prior investigational therapy within 2 weeks prior to study enrollment
Completion of most recent salvage therapy within 8 weeks of enrollment
Severe infection that in the opinion of the investigator would interfere with the patients safety or compliance on trial within 2 weeks prior to enrollment. Oral or IV antibiotics within 2 weeks or 5 half-lives prior to enrollment
Active genital infection at the time of enrollment (if present initially, can be treated and then patient can be re-evaluated for eligibility)
Patients must have a wild type or mutated RAS tumor status known prior to enrollment
Subjects must be willing to have prostate biopsies nine months after enrollment into the protocol.
Any mAb or other protein therapeutic containing Fc-domains within 4 weeks of enrollment
Documented history of capillary leak syndrome within 6 months of study enrollment.
Participants with measurable disease that has progressed are eligible if prior surgery or locoregional therapy occurred > 28 days prior to enrollment
Participants with a history of variceal bleed within 6 months prior to enrollment
alemtuzumab within 6 months of enrollment
other lymphotoxic chemotherapy (including steroids except as below) within 2 weeks of enrollment
Prior therapy wash-out period requirements\r\n* Participants must be at least 4 weeks from prior surgical procedures and surgical incisions must be healed\r\n* Participants must have had their last fraction of external beam radiation therapy at least 4 weeks prior to enrollment; participants with prior radiation therapy must be at least 4 weeks post therapy and have had progression of disease outside the radiation port\r\n* Participants must have had their last dose of cytotoxic chemotherapy at least 28 days prior to enrollment, their last dose of biological therapy, such as biological response modifiers (e.g., cytokines), immunomodulatory agents, vaccines, differentiating agents, used to treat their cancer at least 28 days prior to enrollment, their last dose of a monoclonal antibody at least 28 days prior to enrollment, and their last dose of any investigational agent at least 28 days prior to enrollment\r\n* Participants must have recovered from the acute toxic effects of prior therapy to a grade 1 (Common Terminology Criteria for Adverse Events [CTCAE] v.4.0) level prior to enrollment (does not apply to alopecia)
Cytotoxic chemotherapy last dose must have been received at least 28 days prior to enrollment, their last dose of biological therapy, immunomodulatory agents, vaccines, differentiating agents, used to treat their cancer at least 7 days prior to enrollment, their last dose of a monoclonal antibody at least 30 days prior to enrollment, and their last dose of any investigational agent at least 30 days prior to enrollment
History of use of another IP within the last 4 weeks prior to enrollment.
Prior chemotherapy allowed, but last dose must have been at least 2 months prior to enrollment
If HIV positive, receipt of anti-retroviral therapy continuously for at least 6 months prior to enrollment
Note: Treatment with bicalutamide and nilutamide within 6 weeks prior to enrollment is not allowed; treatment with flutamide within 4 weeks prior to enrollment is not allowed; treatment with all other gonadotrophin-releasing hormone (GnRH) analogues or antagonists is allowed\r\n* Chemotherapy\r\n* Biologic therapy\r\n* Investigational therapy\r\n* Immunotherapy
Last cycle of most recent salvage therapy within 8 weeks of enrollment
The use of hydroxyurea before enrollment is permitted; hydroxyurea should be discontinued prior to start of study treatment; patients with symptoms/signs of hyperleukocytosis or white blood cell count (WBC) >100,000/uL can be treated with leukapheresis or may receive up to 1 dose of cytarabine (up to 500 mg/m^2) anytime prior to enrollment
Patients may take steroids for disease control up to 24 hours prior to study enrollment
BMI < 21 at time of study enrollment
Patients must be actively receiving treatment for their CML with a TKI: imatinib, dasatinib, nilotinib, or bosutinib\r\n* Patients must be on a stable dose of their TKI for at least 1 year prior to enrollment onto trial
Uncontrolled HTN 14 days prior to enrollment
Patients who have been treated with chemotherapy or radiation within two weeks of planned study enrollment; this does not include hydroxyurea, which may be continued until start of conditioning therapy; ruxolitinib may be continued at principal investigator's discretion during conditioning
Prior resection of extra-hepatic metastatic disease allowed if completed more than 12 months previous to study enrollment and no new extra-hepatic disease has been found
BMI < 21 at time of study enrollment
Patients requiring hydroxyurea to bring WBC below 10,000/uL prior to study enrollment will require a 48-hour washout prior to starting the study drug
Use of thiazolidinedione (TZD) within 28 days prior to enrollment
Treatment with high dose immune inhibitors including lymphotoxic monoclonal antibodies such as campath, or rapamycin and its analogs or cytotoxic agents less than 2 weeks prior to enrollment.
PRIOR TO LYMPHODEPLETION: Imaging results from within 30 days prior to enrollment into the main study (used as baseline measure for documentation of progression) before the lymphodepletion; with prior sponsor approval, these results may be obtained at a time point greater than 30 days from lymphodepletion if obtained per the patient’s standard of care and if no other chemotherapy/lymphoma treatment received between most recent scans and start of
If patients are taking systemic therapy for cGVHD at the time of enrollment, they must be receiving stable or tapering doses within the previous 4 weeks; patients are not required to have completed a course of steroids prior to enrollment
Patients will be required to have received prior treatment with azithromycin for at least 3 months prior to enrollment, unless there is evidence of progression or unsatisfactory response while on azithromycin prior to 3 months of treatment, as deemed by the treating or referring physician; patients who are on azithromycin will need to discontinue for at least 2 weeks prior to enrollment
Platelets < 75,000 cell/mm^3 (75 x 10^9/L); qualifying laboratory value must occur at most recent measurement before enrollment and must be no more than 14 days before enrollment; no transfusions are allowed within 72 hours before qualifying laboratory value
Hemoglobin < 8 g/dL; qualifying laboratory value must occur at most recent measurement before enrollment and must be no more than 14 days before enrollment; no transfusions are allowed within 72 hours before qualifying laboratory value
ENTRECTINIB EXCLUSION CRITERIA: Prior treatment with the following anti-neoplastic therapies within the following time frame:\r\n* Any prior treatment with entrectinib\r\n* Any prior treatment with TRK, ROS1, or ALK inhibitors\r\n* Radiotherapy within 2 weeks prior to enrollment\r\n* Whole brain radiotherapy within 2 weeks prior to enrollment, or stereotactic radiation to the brain within 1 week prior to enrollment\r\n* Receipt of any cytotoxic chemotherapy, biologic agent, or investigational agent within 2 weeks prior to the first dose of study drug
Willingness to provide a fresh biopsy prior to study enrollment and after 2 cycles of treatment as clinically appropriate per PI discretion
Patients considered for enrollment are strongly recommended to have been discussed at multidisciplinary tumor board with input from surgery, medical oncology and radiation oncology prior to enrollment
Previous history of haemoptysis (expectoration of more than 2.5 mL of blood), within three months prior to enrollment
Pre-certification for the 90Y TARE should be performed prior to enrollment on this study
Enrollment in any other clinical study from screening up to day 100; enrollment in another clinical study not interfering with the endpoints of this study after day 100 according to the judgment of the PI (or PI designee) will be allowed, but will be clearly documented in the case report form (CRF) and in the patient’s medical file
Patients treated with chemotherapy for lymphoma within 4 weeks of protocol enrollment (including Rituxan)
PHASE I STUDY ELIGIBILITY CRITERIA:\r\nSignificant hemorrhage (> 30 mL bleeding/episode within 3 months before study enrollment) or hemoptysis (> 5 mL fresh blood within 28 days before study enrollment)
Patients with stroke or transient ischemic attack (TIA) within 90 days prior to enrollment; or peripheral vascular disease requiring intervention within the 90 days prior to enrollment; or any known hemodynamically significant lesion or embolic plaque
ST elevation myocardial infarction within 30 days prior to enrollment; unstable angina or significant, untreated arrhythmias within 30 days prior to enrollment
Patients with multiple lesions, which by size criteria would be enrolled in a cohort which is full at the time of enrollment and the 12-16 week dose-limiting toxicity (DLT) period has not yet been reached
Total bilirubin =< 1.5 x ULN for the laboratory at the time of enrollment, all forms of biliary stents allowed
If the patient has been treated with non-steroidal anti-androgens (flutamide, bicalutamide or nilutamide) or other hormonal treatment (such as ketoconazole), these agents must have been stopped at least 28 days prior to enrollment for flutamide or ketoconazole, and at least 42 days prior to enrollment for bicalutamide or nilutamide; and the patients must have demonstrated progression of disease since the agents were suspended
Radiographical documentation of metastatic disease with imaging up to 6 weeks prior to enrollment
Completion of definitive therapy 4-12 weeks prior to enrollment; there are no specific limitations on which treatment modalities can be used in the definitive setting (e.g. the use of adjuvant chemotherapy is acceptable), but all other treatments must be complete at least 4 weeks prior to enrollment
Completion of definitive therapy for oligometastatic disease greater than 12 weeks prior to enrollment
Subjects will be required to agree to a biopsy performed at baseline and again at week 8 of the study in order to be eligible for enrollment in stage 1 of the study
COHORT II: At the time of enrollment, patients must have had bilateral mammograms within 6 months
Circulating peripheral blood myeloblasts or lymphoblasts on morphologic analysis from time of last treatment to time of enrollment
Treatment with androgens within 6 months prior to study enrollment
Participation in a prior investigational study within 4 weeks prior to enrollment or longer if required by local regulation
Patients must not have had a known interruption of TKI therapy of greater than 21 consecutive days or for a total of 6 weeks in the 6 months prior to enrollment.
Melanoma specific systemic therapy within 30 days of enrollment
Patients who have completed previous therapies 4-weeks prior to (or within 5 drug half lives) enrollment on study. Radiation therapy wash out period will be 2 weeks. This includes an exception of patients with metastatic GIST tumors who are taking maintenance imatinib mesylate therapy. These patients are allowed to remain on imatinib mesylate therapy up to enrollment in this study.
Previous enrollment on another study involving the investigation of veliparib (ABT-888), with the exception of receiving a single dose of study drug
Immunomodulatory treatment - patient must have received last dose > 21 days prior to enrollment
Pre-treatment tests must be performed within 30 days prior to enrollment
No hormone ablation for two months prior to enrollment, or during treatment
Patients must have MIBG-avid NB and evaluable disease on MIBG scan at time of enrollment on protocol
Vaccinations against encapsulated bacterial pathogens (Neisseria meningitis, including serogroup B meningococcus, Haemophilus influenzae, and Streptococcus pneumoniae) within 5 years of enrollment
For Cohort A:\n\n          1. Prior history of diagnosis of SAA\n\n          2. Diagnosis of relapsed/refractory SAA or recurrent AA following IST for SAA at the time\n             of enrollment. Patients with recurrent AA (e.g., losing their response) are exempt\n             from meeting the diagnostic criteria for relapsed SAA at the time of enrollment, but\n             must have been previously diagnosed with SAA.\n\n          3. Agree to concurrent eltrombopag treatment with appropriate, investigator-selected IST\n             with either hATG + CsA or CsA.\n\n             For Cohort B:\n\n          4. Diagnosis of SAA at the time of enrollment\n\n          5. Patients must not have been previously treated for SAA\n\n          6. Patients must agree to treatment with hATG + CsA concurrent with eltrombopag.\n\n             For all patients, regardless of cohort:\n\n          7. Age 1 to <18 years\n\n          8. Where appropriate, assessments to rule out congenital/inherited bone marrow failure\n             syndromes and other causes of immune-mediated pancytopenia, which may be treated with\n             transplant, must be completed prior to enrollment.\n\n          9. Hematopoietic stem cell transplantation (HSCT) is not available or suitable as a\n             treatment option or has been refused by the patient. (Candidacy for HSCT will be\n             determined as per local practice.)\n\n         10. Bone marrow aspirate and biopsy at any time during the 4 weeks prior to first dose of\n             eltrombopag\n\n         11. Normal karyotype with FISH for chromosomes 7 and 8\n\n         12. Performance status score: Karnofsky ?50 or Lansky ?50 (depending on age)\n\n         13. Serum creatinine ?2.5 × ULN\n\n         14. Total bilirubin ?1.5 × ULN\n\n         15. Written informed consent signed by a parent or legal guardian prior to initiation of\n             any study specific procedure.\n\n        Exclusion Criteria:\n\n          1. Prior and/or active medical history of:\n\n               -  Fanconi anemia (via chromosomal breakage test or growth arrest by flow cytometry)\n\n               -  Other known underlying congenital/inherited marrow failure syndromes\n\n               -  Symptomatic Paroxysmal Nocturnal Hemoglobinuria (PNH) and/or PNH clones >50% of\n                  PMN or RBC at time of enrollment\n\n               -  Any cytogenetic abnormalities, including but not limited to chromosome 7 or\n                  myelodysplasia, in bone marrow within 4 weeks of study enrollment\n\n               -  Myelodysplastic syndrome (MDS)\n\n               -  Other known or suspected underlying primary immunodeficiency\n\n               -  Any malignancy\n\n          2. Active infection not responding to appropriate therapy\n\n          3. Prior eltrombopag or other thrombopoietin receptor (TPO-R) agonist treatment for at\n             least 2 months and a lack of response.\n\n          4. Any out of range lab values Creatinine >2.5 × upper limit of normal (ULN), Total\n             bilirubin >1.5 × ULN Aspartate aminotransferase (AST) or alanine aminotransferase\n             (ALT) >2.5 × ULN
Hospitalization within 30 days of enrollment for cancer related events
Prior enrollment in NCI protocol 09-C-0139 with receipt of at least 5 doses of TARP peptide vaccine (i.e. completion of primary vaccination series)
Documented myocarditis within 2 months of enrollment
Patient who has participated in a prior investigational study within 30 days prior to enrollment
If WBC ?20,000/?L, cytoreduction with hydroxyurea is permitted prior to enrollment.
Chronic diarrhea as defined by loose or watery stools occurring more than 3 times daily at baseline lasting more than 4 weeks or not abating on condition-appropriate therapy prior to study enrollment
Patient must not have received pegfilgrastim within 14 days of enrollment
T-ALL: T-ALL patients must be enrolled on AALL08B1 or Project:EveryChild (APEC14B1, if open for the classification of ALL patients) prior to treatment and enrollment on AALL1231
Patients must not be in status, coma, or assisted ventilation prior to study enrollment
Daily oral or intravenous corticosteroids for 7 days or longer within one week of enrollment and patient is anticipated to have an increase in dose after study enrollment
Stable systemic cGVHD medication regimen for seven days prior to study enrollment; dose modifications to maintain therapeutic drug levels of immunosuppressants (i.e. tacrolimus and sirolimus) for the month prior and during the study intervention period are allowed and do not constitute a trial violation
Patients must have stable disease at the time of enrollment
Patients must have at least ONE of the following (lesions may have received prior radiation therapy as long as they meet the other criteria listed below):\r\n* Bone disease\r\n** At least one metaiodobenzylguanidine (MIBG) avid bone site or diffuse MIBG uptake\r\n*** For recurrent/progressive or refractory disease a biopsy is not required regardless of number of MIBG avid lesions\r\n*** For persistent disease, if patient has only 1 or 2 MIBG avid lesions OR a Curie score of 1-2, then biopsy confirmation of neuroblastoma and/or ganglioneuroblastoma in at least one site present at the time of enrollment (bone marrow, bone, or soft tissue) is required to be obtained at any time point prior to enrollment and two weeks subsequent to most recent prior therapy; if a patient has 3 or more MIBG avid lesions OR a Curie score of >= 3 then no biopsy is required for eligibility\r\n** If a tumor is known to be MIBG non-avid, then a patient must have at least one fludeoxyglucose (FDG)-positron emission tomography (PET) avid bone site present at the time of enrollment with biopsy confirmation of neuroblastoma and/or ganglioneuroblastoma obtained at any time prior to enrollment and two weeks subsequent to most recent prior therapy\r\n* Any amount of neuroblastoma tumor cells in the bone marrow based on routine morphology (with or without immunocytochemistry) in at least one sample from bilateral aspirates and biopsies\r\n* At least one soft tissue lesion that meets the criteria for a TARGET lesion as defined by:\r\n** SIZE: Lesion can be accurately measured in at least one dimension with a longest diameter >= 10 mm, or for lymph nodes >= 15 mm on short axis; lesions meeting size criteria will be considered measurable\r\n** In addition to size, a lesion needs to meet ONE of the following criteria:\r\n*** MIBG avid; for patients with persistent disease only: if a patient has only 1 or 2 MIBG avid lesions OR a Curie score of 1-2, then biopsy confirmation of neuroblastoma and/or ganglioneuroblastoma in at least one site present at time of enrollment (either bone marrow, bone and/or soft tissue) is required to be obtained at any time point prior to enrollment and at least two weeks subsequent to most recent prior therapy; if a patient has 3 or more MIBG avid lesions OR a Curie score of >= 3 then no biopsy is required for eligibility\r\n*** FDG-PET avid (only if tumor is known to be MIBG non-avid); these patients must have had a biopsy confirming neuroblastoma and/or ganglioneuroblastoma in at least one FDG-PET avid site present at the time of enrollment done prior to enrollment and at least two weeks subsequent to the most recent prior therapy\r\n*** Non-avid lesion (both MIBG and FDG-PET non-avid); these patients must have had a biopsy confirming neuroblastoma and/or ganglioneuroblastoma in at least one non-avid lesion present at the time of enrollment done prior to enrollment and at least two weeks subsequent to the most recent prior therapy
Demonstrate adequate organ function per institutional guidelines for high-dose melphalan and autologous transplant at the time of enrollment
Disease status: stable disease or better at the time of enrollment
Neurologic symptoms or imaging findings that necessitate the use of steroids on the day of enrollment or in the prior 7 days
Any standard therapy for leukemia within 14 days before enrollment (except for hydrea)
Patients must be enrolled on study within 31 days of definitive surgical resection at which time tissue is acquired to determine a diagnosis; patients must be enrolled before treatment begins; the date protocol therapy is projected to start must be no later than five (5) calendar days after the date of study enrollment; patients who are started on protocol therapy on a Phase II study prior to study enrollment will be considered ineligible
Ipilimumab or other immunologically active therapy within 8 weeks of enrollment; NOTE: patients who experience melanoma progression (by RECIST 1.1 criteria) while on or after treatment with PD-1 or PDL-1 antibody may enroll on this study
Re-enrollment: Received at least 3 intravenous doses of ALT-803 with no dose-limiting toxicity (DLT)
Subjects with central nervous system (CNS) (or leptomeningeal) infiltration by AML may be considered for treatment at the Investigator’s discretion and following discussion with the Principle Investigator; all neurologic deficits must be noted prior to enrollment on study
No change in systemic immunosuppressive therapy (type or intensity level) within 2 weeks prior to enrollment
History of cerebro-vascular accident within 6 months of enrollment
Patients must not have evidence of new CNS hemorrhage on baseline MRI obtained within 14 days prior to study enrollment
Cytotoxic chemotherapy, steroids or monoclonal antibody (Mab) within 3 weeks of enrollment, except anti-Tac Mab (i.e. daclizumab) which cannot be used within 12 weeks of enrollment; hydroxyurea is considered different from cytotoxic chemotherapy and may be used up to the day before enrollment providing it is not increased during the week prior to enrollment and that the patient’s disease burden is not decreasing during that time
Off all myelofibrosis (MF)-directed therapy including investigational agents for at least 2 weeks prior to study enrollment and recovered from all toxicities; patient who has been on stable dose of ruxolitinib and has received ruxolitinib =< 6 months prior to the study entry will be considered potentially eligible for the study with the caveat that there is no evidence of loss of response (> 5 cm increase in spleen size from the nadir)
Use of T cell depleting agents for prevention or treatment of rejection at any point prior to or after enrollment in the study
For subjects with CNS involvement: Subjects must have deficits that are stable for a minimum of 14 days prior to enrollment, or seizures that are stable, not increasing in frequency or severity and controlled on current anti-seizure medication(s) for a minimum of 7 days prior to enrollment NOTE: Subjects with leptomeningeal disease or brian tumors with positive cerebral spinal fluid cytology are eligible for this study. Subjects may receive glucocorticoids (at stable or tapering dose) to control CNS symptoms prior to enrollment; however, subjects should receive a stable or tapering dose for at least 7 days prior to enrollment.
Subjects with a history of bleeding related to cancer under study requiring a medical intervention (eg, embolization procedure, RBC transfusion, or hospitalization) within 30 days of study enrollment (Treatment Groups B and C only).
Have a post-transplant response as Partial response (PR) or better at the time of enrollment to this study;
Is unwilling to adhere to contraception criteria from time of enrollment in study to at least 30 days after last dose of IP.
Receipt of any investigational medication within 4 weeks prior to enrollment
Patient must be on a stable dose of octreotide (Sandostatin) long-acting release (LAR) or lanreotide for 3 months prior to study enrollment
Enrollment on any additional investigational agent study. Enrollment on concurrent observational study is allowed following consultation with the Sponsor.
Patients with a history of other malignancies treated curatively greater than one year prior to enrollment and without evidence of relapse at the time of enrollment are eligible
The FHCRC principal investigator (PI) of the study must approve enrollment of all patients with pulmonary nodules
Patients diagnosed with DIPG: any variances in the radiotherapy dose within 10% of the current standard dose (54 Gy) will be discussed with the Sponsor-Investigator to confirm eligibility prior to study enrollment
Patients diagnosed with HGG: any variances in the radiotherapy dose within 10% of the current standard dose (59.4 Gy) will be discussed with the Sponsor-Investigator to confirm eligibility prior to study enrollment.
Patients diagnosed with primary spinal tumors any variances in the radiotherapy dose within 10% of the current standard dose (54 Gy) will be discussed with the Sponsor-Investigator to confirm eligibility prior to study enrollment.
Patients have either Cis or Cis with Ta and/or T1 disease at enrollment or in the past. For those patients with only Ta or T1 disease at enrollment AND with no history of Cis, they must have
At the time of study enrollment, the patient’s treatment regimen must be identified; if the patient’s primary tumor was resected prior to the day of enrollment and a blood specimen for the determination of serum alpha fetoprotein was not obtained prior to that surgery, the patient will be considered to have alpha fetoprotein of greater than 100 ng/mL for the purpose of treatment assignment; if tumor samples obtained prior to the date of enrollment were not sufficient to determine whether small cell undifferentiated (SCU) histology was present, treatment assignment will be made assuming SCU is not present in the tumor
Exposure to any IP during the last 4 weeks prior to enrollment.
Subjects on systemic intravenous or oral corticosteroid therapy with the exception of physiologic doses of corticosteroids (=< the equivalent of prednisone 10 mg/day) or other immunosuppressives such as azathioprine or cyclosporin A are; for these subjects these excluded treatments must be discontinued at least 2 weeks prior to enrollment for recent short course use (=< 14 days) or discontinued at least 4 weeks prior to enrollment for long term use (> 14 days); in addition, the use of corticosteroids as premedication for contrast-enhanced studies is allowed prior to enrollment and on study
Receipt of any investigational medication within 4 weeks prior to enrollment
Are receiving chronic therapy with any of the following medications within 7 days prior to enrollment:
No more than 3 years of ADT is allowed, with the most recent ADT treatment having occurred greater than 6 months prior to enrollment
Prior antitumor therapy within 2 weeks of enrollment (with the exception of somatostatin analogs)
Receipt of any investigational medication within 2 weeks prior to enrollment
Uncontrolled infection within 14 days before study enrollment\r\n* Infection treated with appropriate antimicrobial therapy and without signs of progression/treatment failure does not constitute an exclusion criterion
Subject underwent transplantation at least 3 months prior to enrollment
Uncontrolled infection within 14 days prior to enrollment \r\n* Infection treated with appropriate antimicrobial therapy and without signs of progression/treatment failure does not constitute an exclusion criterion
Patients who are receiving other cancer directed therapy at the time of enrollment
Investigational compound within 4 weeks of enrollment
All necessary baseline studies for determining eligibility must be obtained within 21 days prior to enrollment
Patients on alternative supplements should strongly be encouraged to discontinue them prior to enrollment; if they opt to continue, they may enroll on study as long as they have been receiving the supplement for at least 30 days, there is NO evidence of hepatic, renal or other organ dysfunction, administration is approved by the PI, and administration is documented in the study diary
Patients should have no significant worsening in clinical status for a minimum of 2 days prior to enrollment
Prior exposure to cardiotoxic agent, such as anthracyclines, within 3 months of enrollment
Stable dose of corticosteroids for 4 weeks prior to enrollment; exception permitted with overall principal investigator (PI) approval
Stable dose of glucocorticoids for 4 weeks prior to enrollment
Any other comorbidity that the physician judges to be incompatible with intensive chemotherapy must be reviewed and approved by the study medical monitor before study enrollment
Cholangitis that required treatment or intervention within 4 weeks of study enrollment
Enrollment on a protocol (Children's Oncology Group [COG] or other) which restricts proposed dose modifications
Receiving concurrent androgens, anti-androgens, estrogens, or progestational agents, or received any of these agents within the 6 months prior to enrollment or having taken finasteride or dutasteride within 30 days of registration
Participants must have had their last dose of cytotoxic chemotherapy at least 28 days prior to enrollment, their last dose of biological therapy, such as biological response modifiers (e.g., cytokines), immunomodulatory agents, vaccines, differentiating agents, used to treat their cancer at least 7 days prior to enrollment, their last dose of a monoclonal antibody at least 30 days prior to enrollment, and their last dose of any investigational agent at least 30 days prior to enrollment
Having smoked at least 1 cigarette within 4 weeks of study enrollment
Patients are eligible for the study when a cone and ECC are performed prior to pre-enrollment in the study, and pathologic eligibility criteria are met; the cone and ECC must be performed within 12 weeks prior to pre-enrollment in the study; if the cone and ECC performed prior to pre-enrollment do not meet the pathologic criteria, patients may be pre-enrolled and are allowed 1 repeat cone & ECC after pre-enrollment in order to meet pathologic eligibility criteria
International Prostate Symptom Score (IPSS) < 18 (and < 10 if on medication for benign prostatic hypertrophy such as tamsulosin) at time of enrollment
Clinical evidence of nephrotic syndrome prior to enrollment
Evidence of new intracranial hemorrhage of more than punctate size on MRI assessment obtained within 28 days prior to study enrollment for Participants with HGG
Participants may have had up to two previous cytotoxic therapeutic regimens provided these were discontinued >= 4 weeks before enrollment; the use of antineoplastic agents for non-cancer therapy (i.e. colitis, rheumatoid arthritis) may be allowed provided the patient has been on a stable dose without toxicities greater than grade 1
Thromboembolism within 6 months of enrollment
Radium-223, strontium-89, or samarium-153 therapy within 4 weeks of enrollment
Patients must be at least 28 days post immunosuppressants prior to enrollment
Patients must have completed WBRT > 12 weeks prior to enrollment to limit cases of pseudoprogression; however if new lesions are noted < 12 weeks but > 4 weeks prior to enrollment, those patients are eligible
Other than ongoing ADT, prior treatment with other hormonal agents such as antiandrogens or ketoconazole must have been stopped at least two weeks prior to enrollment
Anti-neoplastic treatment less than 4 weeks prior to enrollment, with the exception of hydroxyurea
Treatment with anti arrhythmia therapy for ventricular arrhythmia < 4 weeks prior to enrollment
Treatment with antiandrogens (e.g., bicalutamide, flutamide, or nilutamide) within 4 weeks of enrollment (day 1 visit)
If taking systemic therapy for cGvHD at the time of enrollment, must be on a stable or tapering schedule in the preceding 4 weeks (extracorporeal photopheresis has to be stopped at least by 4 weeks before enrollment)
Patients must not have received any chemotherapy within 21 days of enrollment, and any acute treatment-related toxicities must have returned to baseline; patients may be receiving Hydrea at time of enrollment
Irradiation: interval from the last dose of local RT, craniospinal RT, and palliative RT for symptomatic disease >= 3 months, >= 6 months, and >= 2 weeks before study enrollment, respectively
Small-molecule inhibitors: interval >= 1 week from last dose before study enrollment; if a previously used agent has a prolonged half-life, the appropriate interval will be determined after consultation with the principal investigator
Recent exposure to cardiotoxic agents (including anthracyclines) within 3 months of enrollment. Subjects with troponin-I and BNP levels above ULN are excluded.
Treatment with other FAP directed drug therapy (including sulindac or celecoxib, fish oil) within 12 weeks of study enrollment.
Radioimmunotherapy (i.e. Zevalin) within 8 weeks of enrollment
Evidence of an active pulmonary, gastrointestinal, genitourinary, or other serious infection at time of enrollment
The FHCRC PI of the study must approve of enrollment of all patients with pulmonary nodules
Hypertension must be well controlled on stable doses of medication for at least two weeks prior to enrollment
Enrollment within 14 days of the completion of End of Treatment Visit of the original study
Patients must have indications for treatment for their B cell malignancy at the time of enrollment on this trial
All patients with a diagnosis of complex atypical hyperplasia or endometrial biopsy within three months of study enrollment OR patients with a diagnosis of grade 1 endometrioid endometrial carcinoma on endometrial biopsy within three months of study enrollment in the presence of one or more of the following: 1) desire for future fertility 2) morbid obesity (body mass index > 40) 3) multiple co-morbidities (American Society of Anesthesiology [ASA] class 3 or 4)
Curran Group status of I-IV at the time of enrollment
Each patient will have undergone definitive resection to be eligible for enrollment; this will be followed by standard of care conformal external beam RT with concurrent TMZ; patients are not permitted to have had any other conventional therapeutic intervention other than steroids, or current radiation or TMZ therapy prior to enrollment (TMZ must have been administered > 6 months before enrollment); patients who receive previous inguinal lymph node dissection, radiosurgery, brachytherapy, or radiolabeled monoclonal antibodies will be excluded and replaced if needed; patients who received immunosuppressive therapy for an autoimmune disorder or an organ transplant and/or require prolonged steroid therapy (> 30 days) will be excluded
MRI scan of the target plexiform neurofibroma(s), performed according to study requirements, including axial and coronal short tau inversion recovery (STIR) images within 4 weeks of enrollment on study; patients with orbital plexiform neurofibromas (PNF’s) must have a baseline ophthalmologic evaluation performed prior to study enrollment by an ophthalmologist familiar with the protocol guidelines; patients with pain associated with the target PNF must be able to fill out the Pain Medication Diary with at least one week of documentation prior to study enrollment
Other anti-cancer therapy up to 14 days prior to enrollment, with the exception of hydroxyurea, which can be given up to 4 days prior to enrollment.
Change in chemotherapy agent is planned 7 days before or after enrollment (change in dose(s) permitted),
Patients will be excluded if they have had any positive fungal culture in the last 30 days prior to enrollment.
Positive blood culture within 48 hours of study enrollment.
Significant co-morbidities within 4 weeks prior to enrollment
Patients who received steroids more than 72 hours prior to study enrollment are eligible but will be analyzed separately
This study will be limited to enrollment of Caucasian males only
Subject with prior history of thrombotic microangiopathy or HUS within 3 months prior to enrollment
There should be no evidence for improvement in KS in the 3 months prior to study enrollment, unless there is also evidence for progression of KS in the 4 weeks immediately prior to enrollment
Concurrent, acute, active opportunistic infection other than oral thrush or genital herpes within 14 days of enrollment
Acute treatment for an infection (other than oral thrush or genital herpes) or other serious medical illness within 14 days of enrollment
Prior radioimmunotherapy within 3 years of enrollment
Prior treatment with capecitabine and/or celecoxib is allowed; however, patients with a documented history (at the time of enrollment) of >= grade 3 toxicities with capecitabine or celecoxib are excluded
INITIAL ENROLLMENT:
ENROLLMENT INTO THE TREATMENT ARMS:
There should be no evidence for improvement in KS in the 3 months prior to study enrollment, unless there is evidence for progression of KS in the 4 weeks immediately prior to study enrollment
Any major operation must have occurred at least 28 days before study enrollment
The subject has received systemic antineoplastic therapy within 14 days of study treatment, (however, hydroxyurea or 6-mercaptopurine can be given for the purposes of cytoreduction up to one day prior to enrollment, with the exceptions noted above in the inclusion criteria)
Radiographic progression, defined by RECIST v.1.1, after the last cancer treatment and within 12 weeks prior to enrollment, compared with scans within 1 year of enrollment.
Prior use of hydroxyurea or isolated doses of cytarabine for palliation (i.e., control of WBC) are allowed but should be discontinued at least 24 hrs prior to enrollment.
There are no restrictions on systemic therapy at enrollment
The two most recent measurements of serum testosterone prior to enrollment must fulfill the following criteria:
Both must be measured within 3 months of enrollment;
Blasts in PB < 20% prior to study enrollment
Off all myelofibrosis-related investigational or standard agents (except for ruxolitinib) for at least 4 weeks prior to study enrollment and recovered from all toxicities; if patient is already on ruxolitinib for a minimum of 16 weeks prior to study enrollment, patient can proceed to mobilization and collection
Received regional hepatic infusion therapy within 6 months of enrollment (RFA allowed >6 months prior to enrollment)
Patients who are receiving other cancer directed therapy at the time of enrollment
All patients must be off previous chemo- and/or radiotherapy for at least three (3) weeks prior to entrance into the study and have recovered from any toxic effects induced by such treatment(s); no nitrosourea type drug or ipilumimab treatments are permitted within the last six (6) weeks prior to enrollment. No major surgery within 14 days of enrollment. Patients may continue to receive anti-estrogen/steroid therapy that has been initiated at least eight weeks prior to enrollment in the study.
Administration of conventional chemotherapy within 2 weeks of enrollment date. In the event that subjects have received chemotherapy > 2 weeks from the date of enrollment, they may be included provided they have recovered from the associated non-hematological toxicities to ? grade 1.
Exposure to high dose Ara-C within 6 months of enrollment.
PART II: Oncology participants must be unwilling or ineligible for further radiation or chemotherapy at the time of enrollment into study
For persistent disease, if patient has only 1 or 2 MIBG avid lesions OR a Curie core of 1 - 2, then biopsy confirmation of neuroblastoma and/or ganglioneuroma in at least one site present at the time of enrollment (bone marrow, bone or soft tissue) is required to be obtained at any time point prior to enrollment and two weeks subsequent to most recent prior therapy. If a patient has 3 or more MIBG avid lesions OR a Curie Score of ? 3 then no biopsy is required for eligibility.
In addition to size, a site needs to meet one of the following criteria: MIBG avid. For patients with persistent disease only: If a patient has only 1 or 2 MIBG avid lesions OR a Curie Score of 1 - 2, then biopsy confirmation of neuroblastoma and/or ganglioneuroblastoma in at least one site present at time of enrollment (either bone marrow, bone and/or soft tissue) is required to be obtained at any time point prior to enrollment and at least two weeks subsequent to most recent prior therapy. If a patient has 3 or more MIBG avid lesions OR a Curie Score of ? 3 then no biopsy is required for eligibility.
Non-avid lesion (both MIBG and FDG-PET non-avid). These patients must have had a biopsy confirming neuroblastoma and/or ganglioneuroblastoma in at least one non-avid lesion present at the time of enrollment done prior to enrollment and at least two weeks subsequent to the most recent prior therapy.
Patients may not be on medical therapy for hypertension at time of enrollment.
Subjects are allowed to have received radiotherapy before enrollment if radiation was given to alleviate pain and/or neurologic compromise as long as there remains areas of measurable disease present; further, at the investigator’s discretion and for patients who are unstable, one cycle of rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone (R-CHOP) during the phase I portion of trial and one cycle of an anthracycline based chemotherapy in the phase II portion of the trial is allowed prior to enrollment but no more than one cycle; for purposes of this trial, prednisone or other corticosteroids used for non-lymphomatous conditions will be allowed; in addition, a prior/recent short course (=< 2 weeks) of steroids for symptom relief of lymphoma-related symptoms will be allowed
Evidence of significant active infection (e.g., pneumonia, cellulitis, wound abscess, etc.) at time of study enrollment
Patients who have started protocol therapy prior to enrollment\r\n* Please note: patient may still enroll if IT therapy was given within 72 hours of study enrollment as part of the diagnostic lumbar procedure
Increasing use of daily doses of opioid analgesics within 28 days prior to enrollment in the study.
Patients must have fully recovered from the effects of any prior surgery, chemotherapy or radiation therapy; a minimum time period of 3 weeks should elapse between the completion of radiation therapy for recurrent/metastatic disease and enrollment in the study; a minimum of 4 weeks should elapse between the completion of chemotherapy or any experimental therapy and enrollment in the study; a minimum of 4 weeks should elapse between prior major surgery (such as open biopsy or significant traumatic injury) and enrollment in the study; a minimum of 2 weeks should elapse between prior minor surgical procedures (such as chemotherapy infusion port placement or core visceral organ biopsy) and enrollment in the study
Pathologically confirmed giant cell tumor of bone within 1 year before study enrollment
Patients must have a normal echocardiogram (EF > 50% normal) without any evidence of cardiac chamber hypertrophy, dilatation or hypokinesis. The Sponsor must be provided with copies of these tests BEFORE Sponsor will approve enrollment. In addition, the sponsor must receive a list of current medications taken by the patient before Sponsor will approve enrollment.
Major surgery (requiring the use of a general anesthetic) within 4 weeks of study enrollment with the exception of transurethral resection of bladder tumor (TURBT)
Able to visualize prostate gland adequately on transrectal ultrasound imaging during enrollment evaluation,
Diagnosis of ALL, in first remission; enrollment on a Children Oncology Group (COG) therapeutic study for ALL is not required
Patient enrollment must occur within 4 calendar months following completion of CRT\r\n* Reminder: after patient enrollment, baseline testing followed by randomization must occur within 2-4 months after completion of CRT
Prior mediastinal or mantle radiation >= 5 years prior to enrollment in the study
Megestrol use at the time of study enrollment.
Neutropenia (absolute neutrophil count < 1.0 x 10^9/L) at the time of study enrollment (bloodwork is not required if patient did not have chemotherapy within past 2 weeks).
Severe anemia (hemoglobin < 8 g/L) not corrected prior to study enrollment (bloodwork is not required if patient did not have chemotherapy within past 2 weeks).
Heart failure exacerbation at the time of study enrollment.
Prior acupuncture treatment within 5 years of enrollment
Already have an ongoing regular yoga practice within 2 months of study enrollment
6-MMP:6-TGN ratio >= 40 within 21 days prior to enrollment
Subject is pregnant at time of enrollment
Has nursed a child within 3 months of study enrollment
Enrollment in another cessation program
Anticipated to undergo pancreatectomy in >= 6 weeks from enrollment
Patients who have a negative urine pregnancy test prior to enrollment; this should be done as part of pre-admission testing prior to surgery (within 14 days of study enrollment)
Enrollment in the SATISFY-SOS study (WUSTL IRB# 201203088, NCT02032030)
Patients will be excluded if they are enrolled in hospice at time of enrollment; however, they will be allowed to continue in the study if they enroll in hospice after beginning the study
Patients will be ineligible if they are participating in an investigational drug treatment trial that requires structured symptom or toxicity reporting at the time of enrollment
Having received Ayurvedic treatment within 6 months of study enrollment.
Receiving chemotherapy or radiotherapy at the time of study enrollment. Anti-her2 directed therapy is not exclusionary.
AI use > 21 days prior to study enrollment
Patients not receiving intravenous, intraperitoneal or oral chemotherapy at the time of enrollment
If patient is taking systemic therapy for cGVHD at the time of enrollment, they must be on a stable or tapering doses in the preceding 4 weeks
Primary malignancy for which the patient received transplant has been stable for 3 months prior to enrollment on study
Parents will be excluded if they are enrolled in hospice at time of enrollment; (however, they will be allowed to continue in the study if they enroll in hospice after beginning the study)
Hemoglobin > 8 g/L within 1 week of enrollment in the study
Resting dyspnea modified Borg Scale > 7 of 10 at enrollment
Within 2 weeks prior to study enrollment the patient must be on a stable dose of medications for management of chemotherapy-induced peripheral neuropathy (CIPN) symptoms; for at least 2 weeks prior to enrollment stable dose is defined as: \r\n* No change in drug class \r\n* Increases or decreases that are less than or equal to 20% of the total dosage; all drug classes are allowed
Platelets less than 50,000 within 6 months prior to study enrollment or
Neutrophil count less than 500 within 6 months prior to study enrollment
On stable doses of any supplements or medications for six weeks prior to enrollment on the study
Patients with documented infection at time of enrollment
Resting heart rate > 120 at the time of study enrollment
Major bleed (WHO grade 3 or 4) within 6 months of enrollment
History of alloimmunization (defined as platelet refractoriness with panel reactive antibody [PRA] > 25%) at the time of or prior to enrollment
If on medication for anxiety, stable dose of medications for management of anxiety symptoms for at least six weeks prior to enrollment with no plans to change meditations in the subsequent four weeks. Increases or decreases allowed within drug class, but changing drug class will make patient in-evaluable
Patients with at least one more chemotherapy appointment at the time of enrollment
Patients are actively being treated for another cancer at the time of enrollment
Within 90 days of enrollment:\r\n* Patients with a proven or probable invasive mold infection are not eligible\r\n* Patients with an incompletely treated invasive yeast infection are not eligible\r\n* Patients with an elevated galactomannan level (>= 0.5 index) within 30 days prior to time of enrollment (if performed) must have a full evaluation for invasive aspergillosis (including a negative chest computed tomography [CT] scan) during that time period to be eligible for enrollment
No planned ostomy creation at time of enrollment
Admitted in the hospital at the time of enrollment
For females, documentation that the participant is being followed with cervical cytology and/or HPV testing per current “Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents” and American Society for Colposcopy and Cervical Pathology (ASCCP) guidelines; cervical cytology must be performed prior to enrollment for women who are overdue for screening per the guidelines; women should also have confirmation of absence of cancer or suspected cancer upon visual examination of the vulva, vagina, and cervix within 12 months prior to enrollment
Regularly practiced meditation (greater than once per week) in the year prior to study enrollment
PILOT PARTICIPANTS AND HEALTHY CONTROLS ONLY: Patients who have regularly practiced meditation (greater than once per week) in the year prior to study enrollment
Prior use of probiotics within 3 months prior to enrollment
Participants may not enroll in this study if they are receiving a study agent at the time of enrollment; a participant who chooses to enroll in a medication trial AFTER initial enrollment in our study will be allowed to stay in the study at the discretion of the study PI
Heart failure exacerbation at the time of enrollment
Initiation of extracorporeal pheresis (ECP) therapy within 4 weeks prior to enrollment
Stable dose of glucocorticoids for 4 weeks prior to enrollment
Resting heart rate > 120 at the time of study enrollment
Resting heart rate > 120 at the time of study enrollment
Severe anemia (hemoglobin [Hb] < 7g/L) not corrected prior to study enrollment (bloodwork is not required if patient did not have recent chemotherapy within the last 2 weeks)
Megestrol use at the time of study enrollment
Heart failure exacerbation at the time of study enrollment
Use of any vaginal preparations within one week prior to study enrollment (exception: subjects currently using a vaginal preparation can enroll after discontinuing treatment for 7 days)
Patients previously enrolled, but excluded as no stent lumen obstruction from mucus retention identified at earlier enrollment (hence excluded at that enrollment)
Histologically proven stage 0-III invasive carcinoma of the breast\r\n* Patient’s must have completed primary surgical resection at least 2 weeks prior to enrollment, radiation at least 2 weeks prior to enrollment and/or cytotoxic chemotherapy at least 6 weeks prior to enrollment in the study
Initiation of sleep aids, including over-the-counter or prescription medications taken for insomnia (melatonin, benzodiazepines, antihistamines, etc.) for < 4 weeks prior to enrollment in the study
Patients must be able to ambulate a minimum of 100 feet prior to enrollment in pulmonary rehab
Enrollment on the SJLIFE protocol
Initiation of extracorporeal pheresis (ECP) therapy within 4 weeks prior to enrollment
GENERAL EXCLUSION CRITERIA FOR SUBPROTOCOLS: Concomitant medications\r\n* Corticosteroids: at the time of consent and enrollment to regimen specific subprotocols, patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment to the subprotocol will not be eligible; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid\r\n* Investigational drugs: patients must meet criteria for prior therapy at the time of consent and enrollment to a subprotocol; other investigational agents may not be administered to patients while they are receiving study drug as part of a subprotocol \r\n* Anticancer agents: patients must meet criteria for prior therapy at the time of consent and enrollment to a subprotocol; other investigational agents may not be administered to patients while they are receiving study drug as part of a subprotocol \r\n* Anti-GVHD agents post-transplant: patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible
Have an interval from their chest RT to the time of enrollment of at least 8 years
At least one focus of HSIL must be identified that is not within a condyloma that may be treated after enrollment into the study
For females, documentation that the participant is being followed with cervical cytology and/or HPV testing per current “Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents” and American Society for Colposcopy and Cervical Pathology (ASCCP) guidelines; cervical cytology must be performed prior to enrollment for women who are overdue for screening per the guidelines; women should also have confirmation of absence of cancer or suspected cancer upon visual examination of the vulva, vagina, and cervix within 12 months prior to enrollment
Pre-enrollment tumor survey: Prior to enrollment on this study, a determination of mandatory disease staging must be performed:
This disease assessment is required for eligibility and preferably should be done within 2 weeks prior to enrollment, but must be done within a maximum of 4 weeks before enrollment.
Individuals who have used photosensitizing drugs within the last 30 days prior to study enrollment, or who will be using a photosensitizing drug during the time of the study, will not be eligible
Individuals who have used any topical medication other than emollients on the test area within 30 days prior to study enrollment; if a study participant requires topical medication to the test area during the study, they will be withdrawn from the study.
Individuals who have used retinoids, steroids, 5-fluorouracil, Levulan, Vaniqua (eflornithine), Solaraze, or imiquimod (Aldara®) anywhere on the body within 30 days prior to enrollment; subjects may be reconsidered for eligibility 30 days after the last topical treatment with such medications
Received rolapitant within 21 days prior to study enrollment
Radiographically-demonstrable metastases at any time prior to the time of enrollment
Patient has diarrhea at the time of enrollment which is Clostridium difficile toxin positive
ENROLLMENT HAS ENDED
Creatinine kinase =< 2.5 x the ULN, within 30 days prior to enrollment
Has evidence of cancer at the time of enrolment, or has surveillance tests planned within 21 weeks after enrollment
Subject has been receiving ruxolitinib therapy for intermediate or high-risk myelofibrosis for >6 months prior to enrollment with no more than 1 dose reduction of ruxolitinib in the 2-8 weeks prior to enrollment and a stable daily dose ?5 mg twice daily (BID) >2 months prior to enrollment.
Participants must not have pneumonia or acute bronchitis for at least 2 weeks prior to enrollment
Patients who have had active infection within 15 days of study enrollment that may be considered to interfere with 68Ga-PSMA PET imaging by the study investigators
Systemic radioisotope therapy within 24 weeks prior to study enrollment
PHASE I: All patients must have MIBG-avid disease and evaluable disease on MIBG scan at the time of enrollment onto the protocol
Incarcerated or otherwise institutionalized at time of enrollment
Patient must not have evidence of a new CNS hemorrhage greater than 0.5 cm on baseline MRI obtained =< 14 days prior to study enrollment
Enrollment will not be restrictive and will encompass patients who are women, minorities and other underrepresented populations
Anti-androgenic therapy within 30 days prior to enrollment
History of having undergone any local ablative therapy to liver prior to enrollment on the trial
Renal insufficiency at the time of enrollment, as determined by eGFR 30 to 60 mL/min/1.73 m^2 by the MDRD model based on a serum creatinine level obtained within 28 days prior to enrollment, unless permitted by the institution’s policy and/or American College of Radiology (ACR) guidance for risk reduction strategies
EXCLUSION CRITERIA - FOR NORMAL HEALTHY FEMALE COHORT: Use of regular medications within 2 weeks prior study enrollment or use of any medications within one week prior to study enrollment, except oral contraceptives or cases which, based on drug's or metabolite's half-life, complete elimination can be assumed
Antibiotic use within 2 months of study enrollment or during the study by self-report
Hospitalization within 30 days of enrollment
Patients scheduled for definitive HNC cancer surgical resection less than 10 days from enrollment or greater than five weeks from enrollment
Antibiotic use within 2 months of study enrollment by self-report
Recruit for at least 9 months at the point of enrollment
Men and women diagnosed with CP-CML, on treatment with dasatinib for a minimum of 2 years at the time of enrollment and in dasatinib-induced complete molecular remission ongoing for at least 1 year prior to study entry.
Subjects with prior reduction mammoplasties or breast reductions performed less than 2 years prior to enrollment to this study.
Patients must be without seizures for at least 14 days prior to enrollment, and patients who receive treatment with AEDs must be on stable doses for at least 14 days prior to enrollment
Patients who are immunosuppressed (including known HIV infection), have a serious active infection at the time of treatment, have interstitial lung disease/pneumonitis, or have any serious underlying medical condition that would impair the ability of the patient to receive protocol treatment. Patients with controlled hepatitis C, in the investigator's opinion, are allowed. Patients with known hepatitis B must be HBeAg and HB viral DNA negative for enrollment. Note that, because of the high prevalence, all patients in the Asia-Pacific region (except Australia, New Zealand, and Japan) must be tested and, if HBsAg positive, must be HBeAg and HB viral DNA negative for enrollment.
Should be willing to submit local HSV-1 serostatus within 28 days prior to enrollment.