Biological parent(s) of participant (child) enrolling on SJMB12; these parents will be assigned to cohort P; the exclusion criteria below do not apply to this cohort
Any factor included as exclusion criteria in the participating center’s treatment policy statement
Further exclusion criteria apply
Current or prior use of immunosuppressive medication within 14 days prior to the first dose Additional Exclusion Criteria for Arm A
Subject requires continuous supplemental oxygen for any reason. Additional Exclusion Criteria for Arm B
For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as outlined for each specific treatment arm. Exclusion Criteria: Exclusion criteria for the 2L Cohort:
Has received trebananib or another angiopoietin-2 directed therapy (prior treatment with bevacizumab is not an exclusion criteria)
PRE-REGISTRATION EXCLUSION CRITERIA
REGISTRATION EXCLUSION CRITERIA
EXCLUSION CRITERIA FOR SECOND-LINE THERAPY: Women who are pregnant or breastfeeding
EXCLUSION CRITERIA FOR SECOND-LINE THERAPY: Anticipated patient survival under 2 months
Patients who have been infected with HBV or HCV including those with inactive disease. Additional exclusion criteria for Combination arm PDR001+CJM112
Olaparib\r\n* No additional exclusion criteria
EXCLUSION CRITERIA FOR ENROLLMENT
EXCLUSION CRITERIA FOR BONE MARROW TRANSPLANT
EXCLUSION CRITERIA FOR BLOOD PROCUREMENT:
EXCLUSION CRITERIA FOR T CELL TREATMENT:
PHASE I EXCLUSION CRITERIA
PHASE II EXCLUSION CRITERIA: Untreated and uncontrolled second tumor in the past 2 years
Patients meeting any one of these exclusion criteria will be prohibited from participating in this study.
Pregnancy or breastfeeding, or intending to become pregnant during the study Exclusion Criteria based on Organ Function or Medical History Cardiovascular Patients who meet the following cardiovascular exclusion criterion will be excluded from study entry:
PROCUREMENT EXCLUSION CRITERIA: Patients with severe intercurrent infection
TREATMENT EXCLUSION CRITERIA
Anti-donor HLA antibodies. Additional exclusion criteria:
EXCLUSION CRITERIA FOR PRE-REGISTRATION:
EXCLUSION CRITERIA FOR REGISTRATION: Pregnant and/or breastfeeding
EXCLUSION CRITERIA FOR REGISTRATION: Symptomatic intrinsic lung disease or extensive tumor involvement of the lungs resulting in dyspnea at rest
EXCLUSION CRITERIA FOR REGISTRATION: Experiencing grade 2 or greater diarrhea
EXCLUSION CRITERIA FOR REGISTRATION: Prior treatment with neratinib
Any ongoing cardiac arrhythmias (including atrial fibrillation) that require medical therapy Ipatasertib-Specific Exclusion Criteria:
Other Exclusion Criteria May Apply.
The following are considered criteria for exclusion from the exploratory genetic research:
Medication-related exclusion criteria
TREATMENT EXCLUSION: Active hemorrhagic cystitis
Prior treatment with Cluster of differentiation 33 (CD33) antibody Further exclusion criteria apply.
Pregnant or nursing (lactating) women Additional exclusion criteria for LXH254 in combination with PDR001
Further exclusion criteria apply
REGISTRATION/RANDOMIZATION EXCLUSION CRITERIA:
Preoperative Exclusion Criteria
Intraoperative Exclusion Criteria
EXCLUSION CRITERIA FOR STRATA A, B, D AND E
EXCLUSION CRITERIA FOR STRATUM C: Patients who are receiving any other anti-cancer or investigational drug therapy are ineligible
Subjects with CNS disease are eligible, with exceptions as noted in the exclusion criteria
PROCUREMENT EXCLUSION CRITERIA: Patients with severe intercurrent infection
PROCUREMENT EXCLUSION CRITERIA: Patients in remission who are enrolled on another study where time to progression or disease free survival is a primary endpoint
TREATMENT EXCLUSION CRITERIA
Major surgery within 14 days before enrollment; biopsies and line placement procedures are not exclusion criteria
ARM A OR C EXCLUSION:
ARM B OR D EXCLUSION:
TREATMENT EXCLUSION
RETREATMENT WITH MODIFIED T-CELLS EXCLUSION CRITERIA: Patient requiring supplemental oxygen or mechanical ventilation
Cohort specific exclusion criteria (cohorts and groups without applicable specific exclusion criteria are not listed separately and should follow the general exclusion criteria)
DONOR: The NMDP guidelines for exclusion criteria will be used.
SCREENING PHASE EXCLUSION CRITERIA
Other exclusion criteria may apply
ARM I EXCLUSION CRITERIA: Any evidence of progressive systemic disease (by RECIST 1.1); those with stable systemic lesion(s) may be considered for enrollment
EXCLUSION CRITERIA FOR DOSE ESCALATION COHORT
ADDITIONAL EXCLUSION CRITERIA FOR DOSE EXPANSION COHORT
Other protocol defined exclusion criteria could apply.
Ejection fraction < 45% will be an exclusion criteria for intensive chemotherapy; such patients may receive low intensity therapy
SCREENING EXCLUSION CRITERIA
Normal MRI exclusion criteria will apply; a standard MRI safety form will be used to identify potential conditions warranting exclusion
MEDICATION-RELATED EXCLUSION CRITERIA
ATEZOLIZUMAB-SPECIFIC EXCLUSION CRITERIA
BEVACIZUMAB-SPECIFIC EXCLUSION CRITERIA
Use of corticosteroids or other immunosuppressive medications per exclusion criteria
RECIPIENT EXCLUSION CRITERIA
IMMUNOTHERAPY-RELATED EXCLUSION CRITERIA
MEDICATION-RELATED EXCLUSION CRITERIA:
PRE-REGISTRATION EXCLUSION CRITERIA
REGISTRATION- EXCLUSION
ADDITION EXCLUSION CRITERIA FOR GROUP A (LOW TUMOR BURDEN) ONLY
STEP 1 SCREENING EXCLUSION CRITERIA
COHORT 1 EXCLUSION CRITERIA
COHORT 2 EXCLUSION CRITERIA
COHORTS 1 AND 2 EXCLUSION CRITERIA
REGISTRATION EXCLUSION CRITERIA
EXCLUSION CRITERIA FOR ALL STUDY ARMS
EXCLUSION CRITERIA SPECIFIC TO PATIENTS WHO WILL BE RECEIVING NAB-PACLITAXEL (ALL ARMS EXCEPT ARM B1 SINGLE AGENT LEAD-IN)
PART 1 EXCLUSION CRITERIA: Subjects < 0.5 M^2
PART 2 GROUP 1 EXCLUSION CRITERIA: Subjects who are currently receiving treatment with drugs or herbal medications that can impact drug metabolism
PART 2 GROUP 2A EXCLUSION CRITERIA: Subjects who are currently receiving treatment with drugs or herbal medications that can impact drug metabolism
PART 2 GROUP 3 EXCLUSION CRITERIA: Subjects who are currently receiving treatment with drugs or herbal medications that can impact drug metabolism
DRUG-SPECIFIC EXCLUSION CRITERIA
EXCLUSION FOR TREATMENT WITH TCRC4-TRANSDUCED CD8+ CELLS
EXCLUSION CRITERIA (ENROLLMENT)
EXCLUSION CRITERIA (TRANSPLANT)
PANOBINOSTAT MAINTENANCE EXCLUSION
EXCLUSION CRITERIA FOR SCREENING:
Known exclusion criteria for leukapheresis, JCAR014, or durvalumab therapy
EXCLUSION CRITERIA FOR LEUKAPHERESIS AND PRE-THERAPY EVALUATION:
EXCLUSION CRITERIA FOR LYMPHODEPLETION CHEMOTHERAPY, JCAR014 AND DURVALUMAB:
EXCLUSION CRITERIA FOR PATIENTS WITH CLL, MCL, OR ALL (COHORT A)
EXCLUSION CRITERIA FOR PATIENTS WITH NSCLC OR TNBC (COHORT B): Platelet count < 75,000/mm^3
EXCLUSION CRITERIA FOR PATIENTS WITH NSCLC OR TNBC (COHORT B): Treatment with other investigational agent(s) within 30 days of planned lymphodepletion
EXCLUSION CRITERIA FOR PATIENTS WITH NSCLC OR TNBC (COHORT B): Active autoimmune disease requiring immunosuppressive therapy
EXCLUSION CRITERIA FOR PATIENTS WITH NSCLC OR TNBC (COHORT B): Serum creatinine > 2.5 mg/dL
EXCLUSION CRITERIA FOR PATIENTS WITH NSCLC OR TNBC (COHORT B): SGOT > 5 x upper limit of normal
EXCLUSION CRITERIA FOR PATIENTS WITH NSCLC OR TNBC (COHORT B): Bilirubin > 3.0 mg/dL
EXCLUSION CRITERIA FOR PATIENTS WITH NSCLC OR TNBC (COHORT B): Patients who are HIV seropositive
EXCLUSION CRITERIA FOR PATIENTS WITH NSCLC OR TNBC (COHORT B): Women who are breastfeeding
EXCLUSION CRITERIA FOR PATIENTS WITH NSCLC OR TNBC (COHORT B): Patients who have contraindication to cyclophosphamide chemotherapy
EXCLUSION CRITERIA FOR TNBC: ANC < 1000/mm^3
EXCLUSION CRITERIA FOR TNBC: Hgb < 9 mg/dl (transfusion permitted to achieve this)
EXCLUSION CRITERIA FOR TNBC: Treatment with other investigational agent(s) within 30 days of planned lymphodepletion
EXCLUSION CRITERIA FOR TNBC: SGOT > 5 x upper limit of normal
EXCLUSION CRITERIA FOR TNBC: Bilirubin > 3.0 mg/dL
EXCLUSION CRITERIA FOR TNBC: Patients who are HIV seropositive
EXCLUSION CRITERIA FOR TNBC: Breast-feeding women
EXCLUSION CRITERIA FOR TNBC: Patients who have contraindication to cyclophosphamide chemotherapy
CAPMATINIB EXCLUSION CRITERIA: Uveal melanoma
CAPMATINIB EXCLUSION CRITERIA: Current participation in another therapeutic clinical trial
CAPMATINIB EXCLUSION CRITERIA: Presence or history of carcinomatous meningitis
CERITINIB EXCLUSION CRITERIA: Uveal melanoma
CERITINIB EXCLUSION CRITERIA: Current participation in another therapeutic clinical trial
CERITINIB EXCLUSION CRITERIA: History of carcinomatous meningitis
REGORAFENIB EXCLUSION CRITERIA: Uveal melanoma
REGORAFENIB EXCLUSION CRITERIA: Current participation in another therapeutic clinical trial
REGORAFENIB EXCLUSION CRITERIA: Previous assignment to treatment during this study; patients permanently withdrawn from study participation will not be allowed to reenter
REGORAFENIB EXCLUSION CRITERIA: Any hemorrhage or bleeding event >= grade 3 within 4 weeks prior to start of regorafenib
REGORAFENIB EXCLUSION CRITERIA: Renal failure requiring hemodialysis or peritoneal dialysis
REGORAFENIB EXCLUSION CRITERIA: Patients with pheochromocytoma
ENTRECTINIB EXCLUSION CRITERIA: Uveal melanoma
ENTRECTINIB EXCLUSION CRITERIA: Current participation in another therapeutic clinical trial
ENTRECTINIB EXCLUSION CRITERIA: Incomplete recovery from any surgery prior to treatment
ENTRECTINIB EXCLUSION CRITERIA: Pulmonary embolism in the 3 months prior to study drug administration
Subjects where more than 10% of the total esophagus volume receives more than 50% of the prescribed RT dose Main exclusion criteria for cPoP
EXCLUSION CRITERIA FOR ALL STRATA EXCEPT STRATUM P
Subjects enrolled on the combination therapy phase must satisfy the above exclusion criteria and also the following:
INCLUSION/EXCLUSION CRITERIA - PART B
Any other ongoing serious medical problem unrelated to cancer or its treatment) that is not covered by the exclusion criteria and which is expected to significantly increase the risk of transplantation
FIRST REGISTRATION-EXCLUSION:
SECONDARY REGISTRATION-EXCLUSION:
DONOR EXCLUSION CRITERIA:
Osteosarcoma participants receiving combination therapy of lenvatinib with ifosfamide and etoposide should meet all the exclusion criteria, with the exception of Criterion Number 6.
EXCLUSION CRITERIA - ARM A:
EXCLUSION CRITERIA - ARM B:
EXCLUSION CRITERIA FOR ENROLLMENT: Most recent alloHCT performed did not utilize PTCy GVHD prophylaxis
EXCLUSION CRITERIA FOR ENROLLMENT: The presence of active GVHD requiring treatment
EXCLUSION CRITERIA FOR ENROLLMENT: The use of immunosuppression for grade II-IV acute GVHD within 28 days prior to the infusion of PTCy-MILs
EXCLUSION CRITERIA FOR ENROLLMENT: The patient’s life expectancy is =< 90 days even with aggressive treatment and/or supportive care, as determined by the treating hematologist/oncologist
EXCLUSION CRITERIA FOR ADDITIONAL PTCy-MILs INFUSION AT RELAPSE: The presence of active GVHD requiring treatment
EXCLUSION CRITERIA FOR ADDITIONAL PTCy-MILs INFUSION AT RELAPSE: Creatinine >= 2.5
EXCLUSION CRITERIA FOR ADDITIONAL PTCy-MILs INFUSION AT RELAPSE: HIV-1/2 or HTLV-1/2 positivity
SCREENING EXCLUSION CRITERIA
MAIN STUDY COHORT EXCLUSION CRITERIA: Evidence of nodal or distant metastases
SCREENING EXCLUSION CRITERIA:
INTRA-OPERATION EXCLUSION CRITERIA (RANDOMIZATION ARMS ONLY)
Any patient ?18 and ?89 who presents for a colonoscopy and who does not have criteria for exclusion
BEVACIZUMAB-SPECIFIC EXCLUSION CRITERIA:
TREATMENT EXCLUSION CRITERIA:
CHEMOTHERAPY/CELL INFUSION EXCLUSION CRITERIA:
EXCLUSION CRITERIA FOR CONSENT B
Other exclusion criteria:
Exclusion criteria (PET specific):\r\n* Pregnant or nursing women; extreme claustrophobia; weight near or greater than 350 pounds
EXCLUSION CRITERIA AT TIME OF PROCUREMENT:
EXCLUSION CRITERIA AT TIME OF INFUSION:
INTRAOPERATIVE EXCLUSION CRITERIA:
Tumor type specific exclusion criteria
Additional exclusion criteria exist
EXCLUSION CRITERIA FOR PRE-REGISTRATION
EXCLUSION CRITERIA FOR REGISTRATION: mucinous adenocarcinoma, borderline tumors
EXCLUSION CRITERIA FOR REGISTRATION: subjects who will undergo intraperitoneal chemotherapy
EXCLUSION CRITERIA FOR REGISTRATION: subjects receiving neoadjuvant chemotherapy for whom interval debulking surgery (assuming adequate response to therapy) is not planned
EXCLUSION CRITERIA FOR REGISTRATION: subjects with comorbidities which would lead to a clinical expectation that they will not survive two years for reasons other than ovarian cancer
PROCUREMENT EXCLUSION CRITERIA:
TREATMENT EXCLUSION CRITERIA:
EXCLUSION CRITERIA FOR CD34+ TOPOFF WITHOUT CONDITIONING (COHORT 2):
EXCLUSION CRITERIA (ALL COHORTS)
EXCLUSION CRITERIA (SUBJECTS STRATIFIED INTO THE THORAX HIGH VOLUME TREATMENT SITE)
Is not receiving B-RAF treatment (Cohort C) (Turnstile II - Chemotherapy/Cell Infusion Exclusion Criteria)
Women who are pregnant or nursing will be excluded (Turnstile II - Chemotherapy/Cell Infusion Exclusion Criteria)
Laboratory criteria for exclusion within 14 days prior to randomization.
Has received autologous HSCT within 6 weeks prior to start of treatment. Other Exclusion Criteria May Apply.
Other exclusion criteria may apply
Platelet count < 125x10^9 / L Exclusion criteria for Group 2
Arm 1 and 2 Exclusion:
Pregnant or lactation. Exclusion criteria for HSV-Tk infusion:
PATIENT EXCLUSION CRITERIA:
DONOR EXCLUSION CRITERIA:
REGISTRATION – EXCLUSION CRITERIA
EXCLUSION CRITERIA FOR TREATMENT: WBC less than or equal to 2000/uL
EXCLUSION CRITERIA FOR TREATMENT: Hct less than or equal to 24%
EXCLUSION CRITERIA FOR TREATMENT: Hgb less than or equal to 8 g/dL
EXCLUSION CRITERIA FOR TREATMENT: ANC less than or equal to 1000
EXCLUSION CRITERIA FOR TREATMENT: Platelets less than or equal to 75,000
PHASE 2 SPECIFIC EXCLUSION CRITERIA
PHASE 1 AND GENERAL EXCLUSION CRITERIA
Patients should not enter the study if any of the following exclusion criteria are fulfilled
ADDITIONAL EXCLUSION CRITERIA FOR PATIENTS IN COMBINATION FULVESTRANT/CABOZANTINIB COHORT
Patients with stable atrial fibrillation are allowed in the study provided they do not meet the other cardiac exclusion criteria
SCREENING EXCLUSION CRITERIA:
EXCLUSION CRITERIA FOR AUTOLOGOUS TRANSPLANT
EXCLUSION CRITERIA FOR MAINTENANCE THERAPY
Other Exclusion Criteria
Other protocol defined exclusion criteria could apply
EXCLUSION CRITERIA:
Must not meet any exclusion criteria defined in main study except for exclusion criteria \Subject must not have primary refractory disease\ which is related to prior carfilzomib
Other exclusion criteria may apply
Further Exclusion criteria apply
Further exclusion criteria apply.
EXCLUSION CRITERIA SEARCH PHASE
EXCLUSION CRITERIA FOR TRANSPLANT PHASE: Life expectancy severely limited by concomitant illness or uncontrolled infection
Subjects enrolled on the combination therapy phase must not meet the above exclusion criteria and must be eligible to receive paclitaxel or FOLFIRI per most current prescribing information, or at the discretion of the Investigator.
EXCLUSION FOR COLLECTION OF T CELLS/PBMCS: Females who are pregnant
EXCLUSION FOR TREATMENT: Females who are pregnant
Further exclusion criteria apply
Further exclusion criteria apply
Step I Exclusion Criteria:
Step II Exclusion Criteria:
PROCUREMENT EXCLUSION CRITERIA:
TREATMENT EXCLUSION CRITERIA:
MEDICATION-RELATED EXCLUSION CRITERIA
METASTATIC SAFETY COHORT EXCLUSION CRITERIA
NEOADJUVANT EXCLUSION CRITERIA
Patients requiring treatment with strong CYP2C8 inhibitors Additional exclusion criteria for PDR001/Everolimus
Patients requiring treatment with a strong CYP3A4 inhibitor or inducer Additional exclusion criteria for PDR001/Panobinostat-
EXCLUSION FOR ENROLLMENT/SCREENING (ARMS 1 AND 2)
EXCLUSION FOR TREATMENT (ARMS 1 AND 2)
Judgment by the Investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements. Exclusion from the genetic research may be for any of the exclusion criteria specified in the main study or any of the following:
Other protocol defined exclusion criteria could apply
Exclusion Criteria – Arms B and C
EXCLUSION CRITERIA PRIOR TO TRANSPLANT:
PRE-REGISTRATION EXCLUSION CRITERIA: Previous treatment with trastuzumab or any other Her2 targeted therapy
REGISTRATION EXCLUSION CRITERIA: Symptomatic intrinsic lung disease or extensive tumor involvement of the lungs resulting in dyspnea at rest
STAGE I EXCLUSION CRITERIA:
STAGE 2 EXCLUSION CRITERIA:
Exclusion of patients with creatinine > 2.0
Exclusion of patients with bilirubin > 2.0
There will be no exclusion criteria based on organ function
A positive hepatitis C serology is an exclusion criterion
There will be no exclusion criteria based on organ function.
EXCLUSION CRITERIA - MAIN PROTOCOL
EXCLUSION CRITERIA FOR CONTINUING THERAPY ON THE EXTENSION PHASE:
Exclusion criteria will include all criteria listed for the main protocol
Additional Exclusion Criteria for dabrafenib and trametinib combination therapy (Cohort B and C as well as subjects that crossover from monotherapy to combination therapy):
EXCLUSION CRITERIA PRIOR TO CELL COLLECTIONS FOR DENDRITIC CELL GENERATION:
EXCLUSION CRITERIA – RECIPIENT ON STANDARD CARE THERAPY
EXCLUSION CRITERIA - RECIPIENT
IBRUTINIB-SPECIFIC EXCLUSION CRITERIA
IDELALISIB-SPECIFIC EXCLUSION CRITERIA
Previously-treated with any conditioning regimen and any GVHD immune suppression prophylaxis and formulation of steroids, except as noted in Exclusion Criteria #2.
CARDIAC EXCLUSION CRITERIA:
Other protocol defined exclusion criteria could apply
Other protocol defined exclusion criteria could apply
There is no exclusion for the presence of cytopenias
REGISTRATION #1 EXCLUSION CRITERIA
Other Exclusion Criteria
IMMUNOTHERAPY-RELATED EXCLUSION CRITERIA:
RE-REGISTRATION EXCLUSION CRITERIA
REGISTRATION EXCLUSION CRITERIA
Direct bilirubin =< 1.5 mg/dl; Note: as many eligible patients will be pancytopenic secondary to their disease or prior treatments, hematologic abnormalities will not be used as a criteria for entry or exclusion
Cardiac Exclusion Criteria: Patients will be excluded if these meet any of the following:
General Exclusion Criteria
Prisoner -Impending Fracture-Specific Exclusion Criteria
Any articular component to impending fracture site. -Actual Fracture-Specific Exclusion Criteria
EXCLUSION CRITERIA FOR SCREENING:
EXCLUSION CRITERIA FOR TREATMENT:
EXCLUSION CRITERIA - INITIAL ENROLLMENT
EXCLUSION CRITERIA FOR TRANSPLANT RECIPIENT
Other protocol defined exclusion criteria could apply
EXCLUSION CRITERIA RELATED TO ZIV-AFLIBERCEPT
No prior treatment with systemic chemotherapy (except as noted in exclusion criteria # 10).
Prior chemotherapy or radiation therapy for this disease (laser and cryotherapy are allowed and are not considered exclusion criteria)
Other protocol defined exclusion criteria could apply
Prior treatment with NaPi2b- targeted therapy. Bevacizumab-Specific Exclusion Criteria (for Participants in Second Ovarian Expansion Cohort Only):
Other protocol defined exclusion criteria may apply.
DOSE ESCALATION COHORT EXCLUSION:
DOSE EXPANSION COHORT EXCLUSION:
They are ineligible by virtue of meeting any exclusion criteria listed above
Known history of MDS or AML Cohort 3 Exclusion Criteria:
Other exclusion criteria may apply
PHASE II REGISTRATION: EXCLUSION CRITERIA:
Other Exclusion Criteria
If female and of child-bearing age, donor must not be pregnant or breastfeeding. Recipient Exclusion Criteria
COHORT 1 EXCLUSION CRITERIA FOR APHERESIS/TUMOR BIOPSY PORTION OF THE TRIAL (closed to enrollment as of 6/22/13):
COHORT 1 EXCLUSION CRITERIA FOR IMMUNOTHERAPY PORTION OF THE TRIAL (closed to enrollment as of 6/22/13):
COHORT 2 EXCLUSION CRITERIA:
Active or chronic hepatitis C and/or B infection Additional exclusion criteria apply
PRE-REGISTRATION EXCLUSION CRITERIA
REGISTRATION EXCLUSION CRITERIA
CYCLE II PORTION ONLY: Must still meet all the exclusion criteria for cycle 1
EXCLUSION CRITERIA FOR PATIENTS
PATIENT EXCLUSION: Palliative performance scale rating < 40
EXCLUSION CRITERIA FOR CROSSOVER THERAPY: History or evidence of active, noninfectious pneumonitis that required treatment with steroids
Participants with prior exposure to a pyrrolobenzodiazepine or indolinobenzodiazepine based drug. Additional Exclusion Criteria for the SC-006 and ABBV-181 Combination Treatment Regimen:
PATIENT EXCLUSION CRITERIA
EXCLUSION CRITERIA-PATIENTS
EXCLUSION CRITERIA-FCGs
EXCLUSION CRITERIA FOR PARENTS: Patient declines assent/consent (if >= 7 years)
EXCLUSION CRITERIA FOR PARENTS: Parent or child participated on prior PRISM intervention study
EXCLUSION CRITERIA FOR PATIENTS: Patient declines assent/consent (if >= 7 years)
EXCLUSION CRITERIA FOR PATIENTS: Patient participated on a prior PRISM intervention study
EXCLUSION - STUDY 1: Parkinson's disease
EXCLUSION - STUDY 1: Stroke
EXCLUSION - STUDY 1: Active foot ulcer
EXCLUSION - STUDY 2: The inclusion/exclusion criteria follows similar criteria for study #1 except only patients with confirmed peripheral neuropathy (VPT big toe greater than 25 volt) will be included; patients who have completed clinical study 1 would be eligible for study 2 if they develop CIPN as defined by VPT assessment
EXCLUSION CRITERIA FOR PATIENT PARTICIPANTS
EXCLUSION CRITERIA FOR CAREGIVER PARTICIPANTS
PHASE 1: No provider exclusion criteria
PHASE 3A/3B: PATIENT EXCLUSION CRITERIA: Non-English speaker
EXCLUSION CRITERIA SPECIFIC TO SURVIVORS:
EXCLUSION CRITERIA FOR BOTH SURVIVORS AND CO-SURVIVORS:
EXERCISE EXCLUSION CRITERIA:
No allergic reactivity has been associated with olfactory training and thus there is no need for any exclusion criteria related to this
No other agents have any possible potentiation or decreased activity related to olfactory training and thus there is no need for any exclusion criteria related to this
There are no other agent-specific exclusion criteria
EXCLUSION CRITERIA FOR FOCUS GROUPS (PHASE I)
EXCLUSION CRITERIA FOR PILOT TESTING (PHASE II)
CAREGIVER EXCLUSION:
PATIENT EXCLUSION CRITERIA:
CAREGIVER EXCLUSION CRITERIA:
There are no exclusion criteria to caregiver participation in this study
PREPROCEDURAL EXCLUSION CRITERIA:
PATIENTS EXCLUSION CRITERIA:
Hepatic encephalopathy Exclusion Criteria Specific to Arm B (Gastric Cancer) (Patients who meet any of the following specific exclusion criteria will be excluded from enrollment in Arm B:)
Ongoing treatment for epilepsy Exclusion Criteria Specific to Arm C (Metastatic Pancreatic Cancer) (Patients who meet any of the following specific exclusion criteria will be excluded from enrollment in Arm C:)
PATIENT PARTICIPANT EXCLUSION CRITERIA (PHASE 1 & 2)
EXCLUSION CRITERIA FOR GROUP 2A AND 2B
No exclusion criteria relating to concomitant medications
EXCLUSION CRITERIA-PATIENTS
EXCLUSION CRITERIA-CAREGIVERS
Patients who will be enrolled on the observational arm should not meet the 3rd and 4th exclusion criteria only
Patients with prior transurethral resection and other prostate procedures are eligible with the exception of the procedures indicated in the exclusion criteria
Pre-procedure Exclusion Criteria
GENERAL EXCLUSION CRITERIA FOR SUBPROTOCOLS: Patients who have an uncontrolled infection are not eligible
GENERAL EXCLUSION CRITERIA FOR SUBPROTOCOLS: Additional agent specific criteria will be included with specific treatment subprotocols
READER STUDY EXCLUSION
PRE-REGISTRATION EXCLUSION
REGISTRATION EXCLUSION
PRE-REGISTRATION EXCLUSION:
REGISTRATION EXCLUSION:
PRE-REGISTRATION EXCLUSION CRITERIA
REGISTRATION EXCLUSION CRITERIA
PRE-REGISTRATION EXCLUSION CRITERIA
REGISTRATION EXCLUSION CRITERIA
EXCLUSION CRITERIA FOR ENROLLMENT (PRE-TRANSPLANT): Pregnant or breastfeeding
EXCLUSION CRITERIA FOR ENROLLMENT (PRE-TRANSPLANT): Non-hematologic malignancy with a life expectancy of < 5 years
EXCLUSION CRITERIA (PRIOR TO IBRUTINIB ADMINISTRATION): Active and uncontrolled acute GVHD grades III or IV
EXCLUSION CRITERIA (PRIOR TO IBRUTINIB ADMINISTRATION): Any uncontrolled active systemic infection
EXCLUSION CRITERIA (PRIOR TO IBRUTINIB ADMINISTRATION): Lactating or pregnant
EXCLUSION CRITERIA (PRIOR TO IBRUTINIB ADMINISTRATION): Uncontrolled cardiac arrhythmias
PRE-REGISTRATION EXCLUSION CRITERIA
REGISTRATION/RANDOMIZATION EXCLUSION CRITERIA
Exclusion criteria for RPFNA
Exclusion criteria for study intervention
DRIVERS EXCLUSION CRITERIA
IF PROTOCOL 2546 SERVES AS AN ADJUNCT PROTOCOL, THE PATIENT ONLY NEEDS TO MEET EXCLUSION CRITERIA 1 THROUGH 3
Exclusion Criteria for 13C-MBT studies:
Exclusion Criteria for 31P-MRS studies
Eligible for donation according to the transplantation center Exclusion Criteria Donor:
A history of miscarriage in the last 6 months, in and of itself, will not be considered an exclusion
Daily treatment with thiazides or ?-blockers (exclusion only if < 3 months)
Good performance status (as defined in Exclusion Criteria)
PRE-REGISTRATION EXCLUSION CRITERIA
REGISTRATION EXCLUSION CRITERIA
Use of antidepressants is permitted if dose has been the same for at least 12 weeks prior to study entry if patient still DOES NOT meet exclusion criteria #3
There will be no exclusion criteria relating to concomitant medications
EXCLUSION CRITERIA FOR CALYPSO TRANSPONDERS:
EXCLUSION CRITERIA (ALL PATIENTS)
Evidence of metastases (pelvic lymph node involvement is not an exclusion criteria); for patients with recurrent prostate cancer, oligometastatic disease (3 or fewer visible metastases) is not an exclusion criterion
EXCLUSION CRITERIA FOR OPEN-ACCESS: More than 6 MET PET scans within the previous 12 months
EXCLUSION CRITERIA FOR ORAL LESION AND NORMAL TISSUE
EXCLUSION CRITERIA FOR DRY MOUTH STUDY
EXCLUSION CRITERIA FOR GUM STUDY
No other appropriate agent-specific exclusion criteria
Other protocol defined exclusion criteria could apply
CANCER-SPECIFIC EXCLUSION CRITERIA
GENERAL MEDICAL EXCLUSION CRITERIA
Having received an investigational drug in an investigational drug trial within the last 30 days before randomization for this clinical trial. Participation in a clinical trial without receiving other investigational drugs (e.g. follow-up phase of a trial, observational study) is permitted. Part B, Exclusion criteria: All exclusion criteria as for Part A, except for inclusion criteria 1 and 12 which are replaced by:
STEP 1: EXCLUSION CRITERIA FOR TUMOR COLLECTION
Other Exclusion Criteria May Apply
Subject Exclusion Criteria for Cohort 1 and Cohort 2:
Subject Exclusion Criteria for Optional Contrast MRIs –Cohort 1 Only:
Prior therapy is not a consideration for protocol entry and prior therapy is not an exclusion criteria
Common exclusion criterion
EXCLUSION CRITERIA - FOR MALE COHORT
EXCLUSION CRITERIA - FOR NORMAL HEALTHY FEMALE COHORT: Chronic therapy with any drugs, except oral contraceptives
EXCLUSION CRITERIA - FOR NORMAL HEALTHY FEMALE COHORT: Hospitalization for any reason up to 8 weeks before enrollment
EXCLUSION CRITERIA - FOR NORMAL HEALTHY FEMALE COHORT: Any condition, according to investigator's best judgement, that prevents the subject to participate in the trial
EXCLUSION CRITERIA - FOR NORMAL HEALTHY FEMALE COHORT: Pregnancy, labor or miscarriage within 12 weeks before admission predicted date
HEALTHY VOLUNTEER EXCLUSION CRITERIA:
PANCREATIC CANCER PATIENT EXCLUSION CRITERIA:
SITE EXCLUSION CRITERIA:
PATIENT EXCLUSION CRITERIA:
PATIENT PARTICIPANTS EXCLUSION CRITERIA:
GARAGE/SITE EXCLUSION:
DRIVER EXCLUSION:
TRIAL EXCLUSION:
PATIENT EXCLUSION:
PROSPECTIVE STUDY POPULATION EXCLUSION
CHART AUDIT EXCLUSION CRITERIA:
There are no specific exclusion criteria for this study.
Criteria 7, Other Exclusion Criteria May Apply
No exclusion criteria for this study
Other Exclusion Criteria
Other Exclusion Criteria May Apply
Additional Exclusion Requirements for arm 1 only (nivolumab Plus TAK-580)
Subjects must be otherwise healthy except for the diagnosis of cancer, as per the exclusion criteria listed below.