Other protocol specified criteria
Other protocol specified criteria
Pathologic criteria:
INCLUSION CRITERIA FOR SCREENING (STEP 0 - PREREGISTRATION)
INCLUSION CRITERIA FOR TREATMENT ASSIGNMENT (STEP 1)
PRE-REGISTRATION INCLUSION CRITERIA:
REGISTRATION INCLUSION CRITERIA:
PRE-REGISTRATION INCLUSION CRITERIA
REGISTRATION INCLUSION CRITERIA
Additional criteria may apply
INCLUSION CRITERIA FOR SECOND-LINE THERAPY: Radiographically measurable disease
INCLUSION CRITERIA FOR SECOND-LINE THERAPY: Platelets >= 75,000/mm^3
INCLUSION CRITERIA FOR SECOND-LINE THERAPY: Hemoglobin >= 9.0 g/dL
INCLUSION CRITERIA FOR SECOND-LINE THERAPY: Patients may have a transfusion of red blood cells to meet the hemoglobin requirement
INCLUSION CRITERIA FOR SECOND-LINE THERAPY: Bilirubin =< 1.5 X the upper limit of normal
INCLUSION CRITERIA FOR THIRD-LINE THERAPY: Radiographically measurable disease
INCLUSION CRITERIA FOR THIRD-LINE THERAPY: ECOG performance status 0 or 1
INCLUSION CRITERIA FOR THIRD-LINE THERAPY: Platelets >= 75,000/mm^3
INCLUSION CRITERIA FOR THIRD-LINE THERAPY: Hemoglobin >= 9.0 g/dL
INCLUSION CRITERIA FOR THIRD-LINE THERAPY: Patients may have a transfusion of red blood cells to meet the hemoglobin requirement
INCLUSION CRITERIA FOR THIRD-LINE THERAPY: Bilirubin =< 1.5 X the upper limit of normal
Inclusion criteria associated with type and status of lymphoma
INCLUSION CRITERIA ASSOCIATED WITH HIV-1 STATUS
GENERAL INCLUSION CRITERIA (TIMELINE: 8 WEEKS PRIOR TO START OF TRIAL, UNLESS OTHERWISE SPECIFIED)
INCLUSION CRITERIA - STRATUM A:
INCLUSION CRITERIA - STRATUM B
SOLID TUMOR INCLUSION CRITERIA:
INCLUSION CRITERIA FOR BLOOD PROCUREMENT:
INCLUSION CRITERIA FOR T CELL TREATMENT:
PHASE I INCLUSION CRITERIA
PHASE II INCLUSION CRITERIA: ECOG performance status of 0-1
PHASE II INCLUSION CRITERIA: Hemoglobin > 9 g/dL
PHASE II INCLUSION CRITERIA: Absolute neutrophil count > 1.5 x 10^9/L
PHASE II INCLUSION CRITERIA: Platelet counts > 100 x 10^9/L
PHASE II INCLUSION CRITERIA: Serum bilirubin < 2 x ULN
PHASE II INCLUSION CRITERIA: Women must not be pregnant or breastfeeding
To be eligible for participation in the study, patients must meet all of the following inclusion criteria:
Refusal to use effective methods of contraception (see inclusion criteria for details).
STEP 2 SCREENING INCLUSION CRITERIA FOR LMS PATIENTS:
PROCUREMENT INCLUSION CRITERIA: Hemoglobin (Hgb) > 8.0 (transfusions allowed)
TREATMENT INCLUSION CRITERIA
If applicable, use of contraception methods or abstinence as defined by the protocol Study-Drug Specific Inclusion Criteria: Trastuzumab plus Pertuzumab
Additional Patient Inclusion Criteria for Patients Assigned to Double Umbilical Cord Blood Arm:
SPECIFIC INCLUSION CRITERIA FOR PRE-SURGICAL COHORT:
SPECIFIC INCLUSION CRITERIA FOR EXPANSION COHORT:
INCLUSION CRITERIA FOR PRE-REGISTRATION (PATIENTS WITH UNKNOWN HER2 MUTATION STATUS TO HAVE TUMOR TISSUE SCREENED):
INCLUSION CRITERIA FOR REGISTRATION (HER2 MUTATION IDENTIFIED BY WASH U GPS LABORATORY): Agree to provide archival tumor material for research
INCLUSION CRITERIA FOR REGISTRATION (HER2 MUTATION IDENTIFIED BY WASH U GPS LABORATORY): ECOG performance status =< 2
INCLUSION CRITERIA FOR REGISTRATION (HER2 MUTATION IDENTIFIED BY WASH U GPS LABORATORY): Absolute neutrophil count: >= 1.5 x 10^9/L (1500/mm^3) within 2 weeks of registration
INCLUSION CRITERIA FOR REGISTRATION (HER2 MUTATION IDENTIFIED BY WASH U GPS LABORATORY): Platelet count: >= 100 x 10^9/L (100,000/mm^3) within 2 weeks of registration
INCLUSION CRITERIA FOR REGISTRATION (HER2 MUTATION IDENTIFIED BY WASH U GPS LABORATORY): Serum creatinine: =< 1.5 x ULN within 2 weeks of registration
INCLUSION CRITERIA FOR REGISTRATION (HER2 MUTATION IDENTIFIED BY WASH U GPS LABORATORY): Total bilirubin: =< 1.5 x ULN (in case of known Gilbert’s syndrome, < 2 x ULN is allowed) within 2 weeks of registration
INCLUSION CRITERIA FOR REGISTRATION (HER2 MUTATION IDENTIFIED BY WASH U GPS LABORATORY): There is no limitation on the number of prior lines of systemic therapy
INCLUSION CRITERIA FOR REGISTRATION (HER2 MUTATION IDENTIFIED AT AN OUTSIDE CLIA CERTIFIED LOCATION): ECOG performance status =< 2
INCLUSION CRITERIA FOR REGISTRATION (HER2 MUTATION IDENTIFIED AT AN OUTSIDE CLIA CERTIFIED LOCATION): Absolute neutrophil count: >= 1.5 x 10^9/L (1500/mm^3) within 2 weeks of registration
INCLUSION CRITERIA FOR REGISTRATION (HER2 MUTATION IDENTIFIED AT AN OUTSIDE CLIA CERTIFIED LOCATION): Platelet count: >= 100 x 10^9/L (100,000/mm^3) within 2 weeks of registration
INCLUSION CRITERIA FOR REGISTRATION (HER2 MUTATION IDENTIFIED AT AN OUTSIDE CLIA CERTIFIED LOCATION): Serum creatinine: =< 1.5 x ULN within 2 weeks of registration
INCLUSION CRITERIA FOR REGISTRATION (HER2 MUTATION IDENTIFIED AT AN OUTSIDE CLIA CERTIFIED LOCATION): Total bilirubin: =< 1.5 x ULN (in case of known Gilbert’s syndrome, < 2 x ULN is allowed) within 2 weeks of registration
INCLUSION CRITERIA FOR REGISTRATION (HER2 MUTATION IDENTIFIED AT AN OUTSIDE CLIA CERTIFIED LOCATION): LVEF >= institutional LLN within 4 weeks of registration
INCLUSION CRITERIA FOR REGISTRATION (HER2 MUTATION IDENTIFIED AT AN OUTSIDE CLIA CERTIFIED LOCATION): There is no limitation on the number of prior lines of systemic therapy
Participant agrees not to participate in another interventional study while on treatment. Randomization Inclusion Criteria
Other Inclusion Criteria May Apply.
Blood transfusion to meet the inclusion criteria will be allowed
Patients who do not meet inclusion criteria
ADDITIONAL EXPANSION COHORT SUBJECT INCLUSION CRITERIA
Eastern co-operative oncology group (ECOG) performance score </=2 at screening Further inclusion criteria apply
Patients with cancer of unknown primary or a rare tumor (i.e., fewer than 15 cases per 100,000 per year) with no approved therapies; (patients in this inclusion criteria must meet all other exclusion and inclusion criteria except inclusion criteria #1)
Absolute neutrophil count ? 1,500. Blood transfusion to meet the inclusion criteria not be allowed.
Further inclusion criteria apply
PRE-REGISTRATION INCLUSION CRITERIA:
REGISTRATION/RANDOMIZATION INCLUSION CRITERIA:
Preoperative inclusion:
Intraoperative inclusion:
INCLUSION CRITERIA FOR STRATA A, B, D AND E
INCLUSION CRITERIA FOR STRATUM C: Patient must have completed immunotherapy (e.g. tumor vaccines, oncolytic viruses, etc.) at least 42 days prior to enrollment
INCLUSION CRITERIA FOR STRATUM C: All races and ethnic groups are eligible for this study
INCLUSION CRITERIA FOR STRATUM C: Platelets >= 75,000 cells/uL (unsupported, defined as no platelet transfusion within 7 days)
INCLUSION CRITERIA FOR STRATUM C: Hemoglobin >= 8 g/dl (may receive transfusions)
INCLUSION CRITERIA FOR STRATUM C: ALT (SGPT) =< 3 x institutional upper limit of normal
INCLUSION CRITERIA FOR STRATUM C: Albumin >= 2 g/dl
INCLUSION CRITERIA FOR STRATUM C: Patients must be willing to use brief courses (at least 72 hours) of steroids as directed for potential inflammatory side effects of the therapy if recommended by their treating physician
Patient has a WHO performance status 0-2. Patients in Arm 1 to 4 must also meet the following inclusion criteria:
PROCUREMENT INCLUSION CRITERIA: Hemoglobin (Hgb) > 8.0 (transfusions allowed)
TREATMENT INCLUSION CRITERIA
PROCUREMENT CRITERIA
TREATMENT INCLUSION
RETREATMENT WITH MODIFIED T-CELLS INCLUSION CRITERIA: Subject has modified T cell product available for release
RETREATMENT WITH MODIFIED T-CELLS INCLUSION CRITERIA: Subject has < 5 % detectable modified T cells in peripheral blood (can be done at any time prior)
RETREATMENT WITH MODIFIED T-CELLS INCLUSION CRITERIA: ALT (SGPT): =< 5 x ULN
Hepatic inclusion within 2 weeks of entry
INCLUSION - TREATMENT: Bilirubin ? 3x
INCLUSION CRITERIA FOR NK CELL DONOR
INCLUSION CRITERIA FOR SELECTED NK CELL DONOR
COHORT A: All other inclusion and exclusion criteria apply
INCLUSION CRITERIA TO ENROLL AND PREPARE CELLS FOR SHIPPING TO UNIVERSITY OF MINNESOTA (UMN) FOR PROCESSING
INCLUSION CRITERIA FOR ELIGIBILITY TO RECEIVE TREATMENT
PATIENT-SPECIFIC INCLUSION CRITERIA
Failure to meet any of the criteria set forth in the inclusion criteria section
SCREENING PHASE INCLUSION CRITERIA
Patients may take steroids for disease control up to 24 hours prior to study enrollment; topical steroids are allowed for CTCL patients as described in inclusion criteria above
Other inclusion criteria may apply
Patient with bilateral LG UTUC may be enrolled if at least one side meets the inclusion criteria for the trial and if the other kidney does not require further treatments (The other kidney can be treated prior to the beginning of the study).
Significant organ dysfunction, not meeting inclusion criteria
All patients must meet the following inclusion and exclusion criteria; NO EXCEPTIONS WILL BE GIVEN
ARM I INCLUSION CRITERIA: Subject is eligible for and agrees to receive standard of care stereotactic radio surgery with or without prior neuro-surgical intervention
ARM I INCLUSION CRITERIA: There are no restrictions on the number of prior lines of treatment for systemic disease
INCLUSION CRITERIA FOR DOSE ESCALATION COHORT
ADDITIONAL INCLUSION CRITERIA FOR DOSE EXPANSION COHORT
Additional cohort-specific criteria may apply.
Other protocol defined inclusion criteria could apply.
INCLUSION CRITERIA FOR URINARY SCREENING
INCLUSION CRITERIA FOR TREATMENT
SCREENING INCLUSION CRITERIA
CRITERIA FOR SCREENING
RECIPIENT INCLUSION CRITERIA
ADDITIONAL INCLUSION CRITERION FOR COHORT 4 (CUTANEOUS HNSCC):
OTHER INCLUSION CRITERIA:
ADDITIONAL INCLUSION CRITERIA PERTINENT ONLY FOR PATIENTS WITH PRIOR ALLOGENEIC TRANSPLANTATION:
FULL STUDY INCLUSION CRITERIA: ECOG PS of 0 or 1
FULL STUDY INCLUSION CRITERIA: Extent of baseline tumor burden will not interfere with causal assessment of treatment-emergent hepatotoxicity, at the investigator’s discretion
PRE-REGISTRATION- INCLUSION CRITERIA
REGISTRATION- INCLUSION CRITERIA
INCLUSION CRITERIA FOR GENETICS RESEARCH STUDY (OPTIONAL)
STEP 1 SCREENING INCLUSION CRITERIA
STEP 2 SCREENING INCLUSION CRITERIA
Within 3 weeks of any corticosteroids except per inclusion criteria above
COHORT 2 INCLUSION CRITERIA
Further inclusion criteria apply
Each patient must be positive for HLA-A*02 and meet all of the following inclusion criteria to be enrolled in the study
PART 1 INCLUSION CRITERIA
PART 2 GROUP 1 INCLUSION CRITERIA: These criteria must be met by all subjects, regardless of bone marrow involvement with tumor
PART 2 GROUP 1 INCLUSION CRITERIA: Shortening Fraction > 27%
PART 2 GROUP 2A INCLUSION CRITERIA: Hgb >= 8 g/dL (may receive RBC transfusion)
PART 2 GROUP 2A INCLUSION CRITERIA: These criteria must be met by all subjects, regardless of bone marrow involvement with tumor
PART 2 GROUP 2A INCLUSION CRITERIA: SGPT (ALT) =< 110 U/L; for the purpose of this study, the ULN for SGPT is 45 U/L
PART 2 GROUP 2A INCLUSION CRITERIA: Shortening Fraction > 27%
PART 2 GROUP 3 INCLUSION CRITERIA: Hgb >= 8 g/dL (may receive RBC transfusion)
PART 2 GROUP 3 INCLUSION CRITERIA: These criteria must be met by all subjects, regardless of bone marrow involvement with tumor
PART 2 GROUP 3 INCLUSION CRITERIA: Shortening Fraction > 27%
DRUG-SPECIFIC INCLUSION CRITERIA
INCLUSION CRITERIA (ENROLLMENT)
INCLUSION CRITERIA (TRANSPLANT)
PANOBINOSTAT MAINTENANCE INCLUSION
Patients with HM, as previously defined, without confirmed response to standard, first-line antineoplastic therapy, and/or who do not fulfill all Inclusion Criteria as stated, will be ineligible to participate in this study.
INCLUSION CRITERIA FOR SCREENING:
INCLUSION CRITERIA FOR LEUKAPHERESIS AND PRE-THERAPY EVALUATION:
INCLUSION CRITERIA FOR LYMPHODEPLETION CHEMOTHERAPY, JCAR014 AND DURVALUMAB:
INCLUSION CRITERIA FOR PATIENTS WITH CLL, MCL OR ALL (COHORT A)
INCLUSION CRITERIA FOR PATIENTS WITH NSCLC OR TNBC (COHORT B): ROR1 expression in > 20% of the primary tumor or metastasis by immunohistochemistry (IHC)
INCLUSION CRITERIA FOR PATIENTS WITH NSCLC OR TNBC (COHORT B): Karnofsky performance status of >= 70%
INCLUSION CRITERIA FOR PATIENTS WITH NSCLC OR TNBC (COHORT B): Ability to understand and provide informed consent
INCLUSION CRITERIA FOR TNBC: Patients may receive agents to protect against skeletal related complications such as zoledronic acid or denosumab
INCLUSION CRITERIA FOR TNBC: ROR1 expression in > 20% of the primary tumor or metastasis by IHC
INCLUSION CRITERIA FOR TNBC: Patients must be off chemotherapy for a minimum of 3 weeks prior to planned leukapheresis
INCLUSION CRITERIA FOR TNBC: Ability to understand and provide informed consent
Patients must have baseline evaluations performed prior to the first dose of study drug and must meet all inclusion and exclusion criteria
Prior therapy with elotuzumab or any immunomodulatory drug (IMiD) (including pomalidomide), except for prior thalidomide or lenalidomide (as defined in inclusion criteria)
Blood transfusion to meet the inclusion criteria will be allowed
DOSE EXPANSION PHASE ADDITIONAL INCLUSION CRITERIA
CAPMATINIB INCLUSION CRITERIA: Documentation of absence of activating and targetable BRAF or NRAS point mutations
CAPMATINIB INCLUSION CRITERIA: Platelets >= 75,000/mcL
CAPMATINIB INCLUSION CRITERIA: Hemoglobin >= 9 g/dL (transfusions are allowed)
CAPMATINIB INCLUSION CRITERIA: Serum potassium, calcium (corrected for serum albumin), magnesium, phosphorus within normal limits with or without supplementation
CERITINIB INCLUSION CRITERIA: ECOG performance status 0-1
CERITINIB INCLUSION CRITERIA: Documentation of absence of activating and targetable BRAF or NRAS point mutations
CERITINIB INCLUSION CRITERIA: Absolute neutrophil count >= 1.5 x 10^9/L
CERITINIB INCLUSION CRITERIA: Platelets >= 75 x 10^9/L
CERITINIB INCLUSION CRITERIA: Hemoglobin >= 8 g/dL (transfusions are allowed)
CERITINIB INCLUSION CRITERIA: Serum amylase =< 2 x ULN
CERITINIB INCLUSION CRITERIA: Serum potassium, calcium (corrected for serum albumin), magnesium, phosphorus within normal limits with or without supplementation
REGORAFENIB INCLUSION CRITERIA: ECOG performance status 0-1
REGORAFENIB INCLUSION CRITERIA: Documentation of absence of activating and targetable BRAF or NRAS point mutations
REGORAFENIB INCLUSION CRITERIA: Platelets >= 100,000/mm^3
REGORAFENIB INCLUSION CRITERIA: Hemoglobin >= 9 g/dL
REGORAFENIB INCLUSION CRITERIA: Serum potassium, calcium (corrected for serum albumin), magnesium, phosphorus within normal limits with or without supplementation
ENTRECTINIB INCLUSION CRITERIA: ECOG performance status 0-2
ENTRECTINIB INCLUSION CRITERIA: Documentation of absence of activating and targetable BRAF or NRAS point mutations
ENTRECTINIB INCLUSION CRITERIA: Platelets >= 75,000/mcL
ENTRECTINIB INCLUSION CRITERIA: Hemoglobin >= 8 g/dL (transfusions are allowed)
ECOG performance status (PS) of 0 or 1 Details and other protocol-defined inclusion criteria may apply
Additional inclusion/exclusion criteria per protocol.
INCLUSION CRITERIA FOR PATIENTS ON ALL STRATA EXCEPT STRATUM P
INCLUSION CRITERIA FOR PATIENTS TO BE TREATED ON STRATUM A
INCLUSION CRITERIA FOR PATIENTS TO BE TREATED ON STRATA B OR C
INCLUSION CRITERIA FOR PATIENTS ON STRATUM D
INCLUSION CRITERIA FOR PATIENTS ON STRATUM P
INCLUSION CRITERIA - PART A
FIRST REGISTRATION-INCLUSION:
SECONDARY REGISTRATION-INCLUSION:
Osteosarcoma participants receiving combination therapy of lenvatinib with ifosfamide and etoposide should meet only Inclusion Criteria Numbers 6 through 17 (after progression in Cohort 2B).
Patient Inclusion Criteria\n\n        Patients must meet all of the following inclusion criteria to be eligible for enrollment\n        into the study:\n\n          -  Histologically or cytologically confirmed metastatic or unresectable solid tumor.\n\n          -  Has failed treatment with all standard therapies for their malignancy.\n\n          -  Adequate Karnofsky Performance Status.\n\n          -  An expected survival of at least 3 months.\n\n          -  Adequate organ and bone marrow function.\n\n          -  Signed informed consent form for study participation prior to screening.\n\n        Patient Exclusion Criteria\n\n        Patients presenting with any of the following will be excluded in the study:\n\n          -  Clinically significant disease as defined by the protocol.\n\n          -  Surgical therapy or other therapies within period as defined by the protocol.\n\n          -  Any condition that will interfere with compliance with the protocol as determined by\n             investigator.
INCLUSION CRITERIA - ARM A:
INCLUSION CRITERIA - ARM B:
INDUCTION PHASE INCLUSION CRITERIA:
RESEARCH PHASE INCLUSION CRITERIA: In patients with suspected liver disease, bilirubin must be =< 2.5 mg/dL
INCLUSION CRITERIA FOR ENROLLMENT: The patient has been off all immunosuppression for at least 2 weeks at the time of PTCy-MILs collection
INCLUSION CRITERIA FOR ENROLLMENT: Expectation of ability to safely undergo salvage treatment appropriate for the patient’s malignant disease type
INCLUSION CRITERIA FOR ADDITIONAL PTCy-MILs INFUSION AT RELAPSE: No active acute infections
INCLUSION CRITERIA FOR ADDITIONAL PTCy-MILs INFUSION AT RELAPSE: No requirement for systemic steroids
INCLUSION CRITERIA FOR ADDITIONAL PTCy-MILs INFUSION AT RELAPSE: Platelets >= 100,00/uL (transfusions are permitted)
INCLUSION CRITERIA FOR ADDITIONAL PTCy-MILs INFUSION AT RELAPSE: Hemoglobin >= 9.0 g/dL (transfusions are permitted)
INCLUSION CRITERIA FOR ADDITIONAL PTCy-MILs INFUSION AT RELAPSE: AST (aspartate aminotransferase) =< 3 x ULN
INCLUSION CRITERIA FOR ADDITIONAL PTCy-MILs INFUSION AT RELAPSE: ALT (alanine aminotransferase) =< 3 x ULN
INCLUSION CRITERIA FOR ADDITIONAL PTCy-MILs INFUSION AT RELAPSE: Bilirubin =< 1.5 x ULN
INCLUSION CRITERIA FOR ADDITIONAL PTCy-MILs INFUSION AT RELAPSE: Expectation of ability to safely undergo salvage treatment appropriate for the patient’s malignant disease type
There is no upper limit on the number of prior treatments provided all inclusion/exclusion criteria are met
SCREENING INCLUSION CRITERIA
MAIN STUDY COHORT INCLUSION CRITERIA: Presence of a solid enhancing cT1 renal mass (i.e. =< 7 cm) diagnosed on cross-sectional imaging
MAIN STUDY COHORT INCLUSION CRITERIA: Scheduled to undergo surgery with either partial or radical nephrectomy
SCREENING INCLUSION CRITERIA:
PROTOCOL-SPECIFIC CRITERIA:
PROTOCOL-SPECIFIC CRITERIA:
Patient does not meet the requirements for prior ipilimumab treatment listed in inclusion above
Chemotherapy, radiation, or immunotherapy, within 2 weeks prior to study entry, other than those specified in the inclusion criteria (hydroxyurea and hypomethylating agents)
INCLUSION CRITERIA PATIENTS WITH SOLID TUMOR CANCERS AND MELANOMA
INCLUSION CRITERIA FOR PATIENTS WITH MALIGNANT MENINGIOMA
INCLUSION CRITERIA ALL PATIENTS
TREATMENT INCLUSION CRITERIA:
TURNSTILE I INCLUSION CRITERIA:
CHEMOTHERAPY/CELL INFUSION INCLUSION CRITERIA:
Patients must meet IWCLL 2008 Guideline [13] criteria for active disease requiring treatment. Each patient with NHL must meet all of the following inclusion criteria to be enrolled on the study:
COHORTS 1 AND 2: HEALTHY VOLUNTEERS: Does not meet inclusion criteria
COHORT 3: ATOPIC DERMATITIS PATIENTS: Does not meet inclusion criteria
INCLUSION CRITERIA FOR OBSERVATION (CONSENT A)
INCLUSION CRITERIA FOR TREATMENT WITH VELIPARIB AND RADIATION (CONSENT B)
Other protocol-defined inclusion/exclusion criteria may apply
Patients with bilateral hydronephrosis unless at least one side has been stented and renal function fulfils the required inclusion criteria
INCLUSION CRITERIA AT TIME OF PROCUREMENT:
INCLUSION CRITERIA AT TIME OF INFUSION:
Central nervous system (CNS) metastases which do not meet the criteria outlined in the inclusion criteria
Refractory to standard available therapies. Expansion Cohort 1 Specific Inclusion Criteria:
Not eligible for Expansion Cohort 3. Expansion Cohort 2 Specific Inclusion Criteria:
Not eligible for Expansion Cohort 3. Expansion Cohort 3 Specific Inclusion Criteria:
Additional inclusion criteria exist
EXCLUSION CRITERIA FOR REGISTRATION: subjects receiving chemotherapy regimens not specified in the inclusion criteria
PROCUREMENT INCLUSION CRITERIA:
TREATMENT INCLUSION CRITERIA:
INCLUSION CRITERIA FOR CD34+ TOPOFF WITHOUT CONDITIONING (COHORT 2):
INCLUSION CRITERIA (ALL COHORTS)
INCLUSION CRITERIA (SUBJECTS STRATIFIED INTO THE THORAX HIGH VOLUME TREATMENT SITE)
Patients with tumor parameters that fall outside of the inclusion criteria above will not be eligible
Patients must be HLA-A2 for cohort A (Turnstile II-Chemotherapy/Cell Infusion-Inclusion Criteria)
Patients must have measurable metastatic melanoma (Turnstile II - Chemotherapy/Cell Infusion -Inclusion Criteria)
Patients of both genders must practice birth control for four months after receiving the preparative regimen (Turnstile II - Chemotherapy/Cell Infusion - Inclusion Criteria)
Serum creatinine less than or equal to 1.6 mg/dl (Turnstile II - Chemotherapy/Cell Infusion-Inclusion Criteria)
INCLUSION CRITERIA FOR NB
INCLUSION CRITERIA FOR CCT: age between 1 and 21 years and able to cooperate with radiation safety restrictions during therapy period
INCLUSION CRITERIA FOR CCT: minimum life expectancy of eight weeks
INCLUSION CRITERIA FOR CCT: signed informed consent indicating awareness of the investigational nature of this program
Capable of giving signed informed consent which includes compliance with the requirements and restrictions specified. Additional Inclusion criteria for Subjects in Part 2:
Subject must be able to provide an evaluable core or excisional biopsy prior to the start of treatment. Other Inclusion Criteria May Apply
Other inclusion criteria may apply
LV mass on CMR > 200 grams (g) Inclusion Criteria for Group 1
Has received 2-6 prior chemotherapy regimens including taxanes in advanced setting Additional Inclusion Criteria for Dose Expansion Part Only:
Pregnant or nursing (lactating) women Other protocol-related inclusion/exclusion criteria may apply
Status after bilateral oophorectomy ( 28 days prior to first study treatment) Inclusion Criteria unique to the AR+ve, TNBC cohort:
Other protocol-defined inclusion/exclusion criteria may apply
Failure to meet inclusion criteria;
Other inclusion criteria apply.
PATIENT INCLUSION CRITERIA:
DONOR INCLUSION CRITERIA:
REGISTRATION – INCLUSION CRITERIA
PRE-REGISTRATION: Determined by study doctor that patient is unlikely to meet inclusion criteria after screening.
Eligibility for ASCT is determined by the above inclusion criteria.
One or more of the inclusion criteria are not met
Inclusion Criteria:\n\n        Patients eligible for inclusion in this study have to meet all of the following criteria:\n\n          -  Patient must have had at least one prior line of therapy for their disease and must\n             not be beyond 4th progression/relapse of disease (5 maximum prior lines).\n\n          -  Patient has a pathology confirmed diagnosis of a solid tumor or lymphoma listed in the\n             section \condition\. Patients must have measurable disease as per appropriate\n             guidelines (Solid Tumors by RECIST 1.1 and Diffuse Large B-cell Lymphoma by Revised\n             Response Criteria for Malignant Lymphoma - Cheson et al 2007).\n\n          -  Expansion Cohorts only: Patient must have a site of disease amenable to biopsy, and be\n             a candidate for tumor biopsy according to the treating institution's guidelines.\n             Exceptions may be considered after discussion with the sponsor.\n\n        Exclusion Criteria:\n\n        Patients eligible for this study must not meet any of the following criteria:\n\n          -  History of severe hypersensitivity reactions to other mAbs.\n\n          -  Impaired cardiac function or clinically significant cardiac disease.\n\n          -  Active, known or suspected autoimmune disease or a documented history of autoimmune\n             disease within three years prior to screening with a few exceptions as per protocol.\n\n          -  Patients previously exposed to anti-PD-1/PD-L1 treatment who are adequately treated\n             for skin rash or with replacement therapy for endocrinopathies should not be excluded.\n\n          -  Patient with second primary malignancy within < 3 years of first dose of study\n             treatment.\n\n          -  Prior immunotherapy treatment with PD-1, PD-L1, CTLA-4, or LAG-3 antibodies.\n\n        Other protocol-defined inclusion/exclusion criteria may apply.
CONSOLIDATION CRITERIA:
MAINTENANCE CRITERIA:
ADDITIONAL INCLUSION CRITERIA FOR PATIENTS IN COMBINATION FULVESTRANT/CABOZANTINIB COHORT
INCLUSION CRITERIA AT TIME OF INITIAL ENROLLMENT:
Blood transfusion to meet the inclusion criteria will not be allowed
Central nervous system (CNS) metastases which do not meet the criteria outlined in inclusion criteria
Biopsy does not meet inclusion criteria
OTHER INCLUSION CRITERIA:
SCREENING INCLUSION CRITERIA:
CHEMOTHERAPY/ADOPTIVE CELL TRANSFER INCLUSION CRITERIA:
-\n\n        All patients must meet the following inclusion criteria:\n\n          1. Metastatic or unresectable locally advanced NSCLC\n\n          2. Evidence of a tumor with one or more EGFR mutations excluding exon 20 insertion\n\n          3. Biopsy of either primary or metastatic tumor tissue within 60 days of dosing\n\n          4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1\n\n          5. Minimum age of 18 years\n\n          6. Adequate hematological and biological function\n\n          7. Written consent on an IRB/IEC-approved Informed Consent Form (ICF) prior to any\n             study-specific evaluation\n\n        Phase 2 Cohorts must also meet the following inclusion criteria:
INCLUSION CRITERIA FOR AUTOLOGOUS TRANSPLANT
INCLUSION CRITERIA FOR MAINTENANCE THERAPY
Regulatory Criteria:
Patients with bilateral hydronephrosis unless at least one side has been stented and renal function fulfills the required inclusion criteria
Other protocol defined inclusion criteria could apply
Anastomosis or procedure (TME) was performed differently from what was defined in the inclusion criteria.
INCLUSION CRITERIA:
ECOG performance status of 0-2 Inclusion Criteria for Phase 2 Sub-study Cohort:
Must meet all inclusion criteria defined in main study and in addition the following criteria must be met:
History of other active malignancies, including myelodysplastic syndrome (MDS), within the past 3 years prior to study entry Other protocol defined inclusion/exclusion criteria could apply
Other inclusion criteria may apply
History of a primary invasive malignancy not listed in the inclusion criteria, which has not been in remission for at least 3 years. The following are exempt from the 3 year limit:
Further Inclusion criteria apply
Further inclusion criteria apply.
INCLUSION CRITERIA SEARCH PHASE
INCLUSION CRITERIA FOR TRANSPLANT PHASE
Known active Hepatitis B or C infections Inclusion Criteria for Part B: To qualify for enrollment, the following criteria must be met:
Subjects in the combination therapy cohorts must meet the above inclusion criteria and be eligible to receive paclitaxel or FOLFIRI per most current prescribing information, or at the discretion of the Investigator.
INCLUSION CRITERIA FOR COLLECTION AND STORAGE OF PERIPHERAL BLOOD MONONUCLEAR CELL (PBMC)/T CELLS
INCLUSION CRITERIA FOR MODIFIED T CELL INFUSION
Other protocol-defined inclusion/exclusion criteria.
Participants with prior therapy, other than therapy specified in inclusion criteria
Tumor specific inclusion criteria:
Further inclusion criteria apply.
Successful T cell test expansion (to be performed as part of inclusion criteria until 3 subjects meet all enrollment criteria)
REGULATORY CRITERIA:
Step I Inclusion Criteria:
Step II Inclusion Criteria:
PROCUREMENT INCLUSION CRITERIA:
TREATMENT INCLUSION CRITERIA:
Pregnant, Other protocol-defined inclusion/exclusion criteria may apply
Patients must have acceptable organ function as defined below. However, as noted above, drug-specific inclusion/exclusion criteria specified in the protocol appendix for each agent will take precedence for this and all inclusion criteria:
Additional criteria may apply.
Additional criteria may apply.
Note: Patients who fail to meet the inclusion/exclusion criteria should not, under any circumstances, be initiated on study treatment; there can be no exceptions to this rule, although during protocol development, discussions about certain criteria are possible and may be amended, depending on new data and specific study requirements; where patients that do not meet the inclusion criteria are incorrectly started on treatment, or where patients subsequently fail to meet the study criteria post initiation, the investigator should inform the AZD2014 team immediately; the AZD2014 team is to ensure all such contacts are appropriately documented
Patients with a diagnosis of other peripheral T-cell lymphoma (PTCL) histologies other than those specified in the inclusion criteria
Concomitant therapy medications that include corticosteroids (except as indicated in inclusion criteria)
COHORT A (MEDICAL) SPECIFIC INCLUSION:
Patients must fulfill all of the general inclusion criteria
COHORT B (SURGICAL) SPECIFIC INCLUSION:
Patients must fulfill all the general inclusion criteria
Blood transfusion to meet the inclusion criteria will be allowed
Inclusion Criteria For entire trial:\n\n          -  Adult > or = 18 years old\n\n          -  has signed the Informed Consent Form\n\n          -  has tumor tissue available for the analysis as described in the protocol\n\n          -  has an Eastern Cooperative Oncology Group performance status ?2\n\n          -  has adequate bone marrow and organ function as defined in the protocol\n\n          -  is able to swallow and retain oral medication\n\n          -  has either measurable or non-measurable disease as per RECIST 1.1.\n\n        Inclusion Criteria for the BYL719+ Everolimus combination - escalation phase - all above\n        plus has a histologically/cytologically confirmed metastatic and/or recurrent solid tumors\n        for whom no standard therapy exists.\n\n        Inclusion Criteria for the BYL719+ Everolimus combination - expansion phase, renal cell\n        carcinoma cohort - all of above first 7 criteria plus has an histologically/cytologically\n        confirmed Renal Cell Cancer as detailed in the protocol\n\n        Inclusion Criteria for the BYL719+ Everolimus combination - expansion phase, pancreatic\n        NeuroEndocrine Tumor cohort\n\n        - all of above first 7 criteria plus has an histologically/cytologically confirmed\n        pancreatic NeuroEndocrine Tumor as detailed in the protocol\n\n        Inclusion Criteria for the BYL719+ Everolimus combination - expansion phase, mTOR\n        inhibitor-pretreated patients' cohort - all of above first 7 criteria plus has a\n        histologically and/or cytologically confirmed solid malignancy as described in the protocol\n\n        Inclusion Criteria for the breast cancer cohorts in escalation and expansion phases, - all\n        of above first 7 criteria plus is post-menopausal and has a histologically and/or\n        cytologically confirmed diagnosis of breast cancer as described in the protocol\n\n        Specific Inclusion Criteria at the time of cross-over (breast cancer, expansion phase),\n\n        - Patient randomized to the alpelisib and exemestane combination who has a radiologically\n        documented progressive disease as detailed in the protocol\n\n        Exclusion Criteria:\n\n          -  Patient has received previous treatment with a PI3K and/or AKT and/or mTOR inhibitor\n             (mTOR inhibitor is allowed in expansion cohorts where patients should have areceived a\n             prior mTOR inhibitor)\n\n          -  Known intolerance or hypersensitivity to Everolimus or other rapamycin analogs\n\n          -  Patient with primary central nervous system (CNS) tumor or CNS tumor involvement as\n             detailed in the protocol\n\n          -  Patient with diabetes mellitus, or documented steroid-induced diabetes mellitus\n\n          -  Patient has a history of another malignancy within 2 years prior to starting study\n             treatment as described in the protocol\n\n          -  Patient who has not recovered to grade 1 or better (except alopecia) from related side\n             effects of any prior antineoplastic therapy as detailed in the protocol\n\n          -  Patient who has had systemic therapy within 4 weeks (6 weeks for nitrosoureas or\n             mitomycin C) prior to starting study treatment\n\n          -  Patient who has received radiotherapy ? 4 weeks prior to starting study drugs, with\n             exception of palliative radiotherapy (? 2 weeks prior to starting study drugs), who\n             has not recovered from side effects of such therapy to baseline or Grade ? 1 and/or\n             from whom ? 30% of the bone marrow was irradiated\n\n          -  Patient who has undergone major surgery ? 4 weeks prior to starting study treatment or\n             who has not recovered from side effects of such procedure\n\n          -  Patient has a clinically significant cardiac disease or impaired cardiac function or\n             any severe and/or uncontrolled medical conditions as detailed in the protocol\n\n          -  Patient who is currently receiving medication with a known risk of prolonging the QT\n             interval or inducing Torsades de Pointes (TdP) and the treatment cannot either be\n             discontinued or switched to a different medication prior to starting study drug\n             treatment\n\n          -  Patient who has participated in a prior investigational study within 30 days prior to\n             enrollment as described in the protocol\n\n          -  Patient who is currently receiving treatment with drugs known to be moderate or strong\n             inhibitors or inducers of isoenzymes CYP34A or CYP2C8 as described in the protocol.\n             Switching to a different medication prior to start of treatment is allowed\n\n          -  Patient with impaired gastrointestinal (GI) function or GI disease that may\n             significantly alter the absorption of oral alpelisib, everolimus, exemestane\n\n          -  Patient with known positive serology for human immunodeficiency virus\n\n          -  Patients who have received live attenuated vaccines within 1 week of start of study\n             drug and during the study as specified in the protocol.\n\n          -  Pregnant or nursing (lactating) woman as detailed in the protocol.\n\n          -  Patient who does not apply highly effective contraception during the study and through\n             the duration as defined in the protocol\n\n          -  Patients in the mTOR inhibitor-pretreated cohorts: all of above first 19 criteria plus\n             have discontinued prior mTOR inhibitor therapy due to non-tolerable toxicity
Inclusion Criteria – Arms B and C
Patients failing to meet the inclusion criteria
INCLUSION CRITERIA PRIOR TO TRANSPLANT:
REGISTRATION INCLUSION CRITERIA: Hemoglobin >= 10 g/dL
Other protocol-defined inclusion/exclusion criteria may apply
PATHOLOGICAL CRITERIA:
All patients require an initial diagnosis of a malignant glioma as outlined in the inclusion criteria which must be confirmed at the treating facility
STRATUM A INCLUSION CRITERIA:
STRATUM B INCLUSION CRITERIA:
STAGE I INCLUSION CRITERIA:
STAGE 2 INCLUSION CRITERIA:
SPECIFIC INCLUSION CRITERIA FOR PHASE II
Previous receipt of brentuximab vedotin Please note that there are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.
Central nervous system (CNS) metastases which do not meet the criteria outlined in inclusion criteria
INCLUSION CRITERIA - MAIN PROTOCOL
INCLUSION CRITERIA FOR CONTINUING THERAPY ON THE EXTENSION PHASE:
Failure to meet any of the criteria set forth in inclusion
UNRELATED DONOR INCLUSION CRITERIA
History of another malignancy within the previous 5 years other than curatively treated non-melanomatous skin cancer Open-Label Treatment Period: The following inclusion criteria apply to patients receiving enzalutamide or placebo during double-blind treatment. Eligible patients must meet all inclusion criteria.
Patients with locally recurrent sarcoma after surgery alone are eligible for enrollment if other inclusion criteria are met.
Eastern Cooperative Oncology Group (ECOG) score 0-1 and one disease specific criteria as listed in the protocol Cohort C Inclusion Criteria:
Ongoing ? Grade 2 toxicities from previous cancer therapies unless specifically allowed in the Inclusion/Exclusion criteria. Use of immunosuppressive medication other than steroids within 28 days before the first dose of MEDI-551
Other protocol-defined inclusion/exclusion criteria may apply
SLE INCLUSION:
SYSTEMIC SCLEROSIS (SSc) INCLUSION:
MS INCLUSION:
No prior treatment for diagnoses in inclusion criteria 1
Diagnosis of grade 1 endometrioid endometrial carcinoma without the presence of one of the 3 criteria mentioned in inclusion criteria 1
DIAGNOSTIC CRITERIA
INCLUSION CRITERIA - ALL PARTICIPANTS
INCLUSION CRITERIA - RECIPIENT
CRITERIA FOR ALL SUBJECTS:
Central nervous system (CNS) metastases which do not meet the criteria outlined in the inclusion criteria
History of lymphoid malignancy other than those allowed per inclusion criteria
Prior chemotherapy other than inclusion criteria
Additional inclusion criteria for phase 2 Subjects only:
Mesothelin-positive refractory/recurrent MPM (Group 2 only) Inclusion Criteria Part B
INCLUSION CRITERIA FOR SBRT vs. RFA RANDOMIZATION
INCLUSION CRITERIA FOR NON-RANDOMIZED SBRT ARM
Criteria:
Criteria:
Criteria:
A patient is eligible for second enrollment (allo-cellular therapy) if all of the following inclusion criteria are met:
Other protocol defined inclusion criteria could apply
Other protocol defined inclusion criteria could apply
REGISTRATION #1 INCLUSION CRITERIA
Patients must meet laboratory, and bone marrow histological criteria for primary myelofibrosis as defined by World Health Organization (WHO) diagnostic criteria as follows: WHO diagnostic criteria for PMF Proposed Criteria for PMF Major Criteria
Inclusion Clinical Laboratories Criteria
Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion criteria may apply
Additional criteria may apply
Additional criteria may apply
Other protocol-defined inclusion/exclusion criteria may apply
PRE-REGISTRATION INCLUSION CRITERIA: Scheduled for a transurethral resection of bladder tumor (TURBT)
PRE-REGISTRATION INCLUSION CRITERIA: Be a candidate for radical cystectomy
PRE-REGISTRATION INCLUSION CRITERIA: Willing to submit tissue for required correlative research
REGISTRATION INCLUSION CRITERIA
INCLUSION CRITERIA - HPC-A CELL DONOR: At least 18 years of age
INCLUSION CRITERIA - HPC-A CELL DONOR: Family member (first degree relatives)
INCLUSION CRITERIA - HPC-A CELL DONOR: Not breast feeding
Central nervous system (CNS) metastases which do not meet the criteria outlined in inclusion criteria
Tumor invasion of bone (also see inclusion criteria)
Tumors in locations other than those specified in inclusion criteria
General Inclusion Criteria
VAS Pain Score > 60mm on 100mm scale. -Impending Fracture-Specific Inclusion Criteria
Destruction of cortical bone at impending fracture site > 50%. -Actual Fracture-Specific Inclusion Criteria
INCLUSION CRITERIA FOR SCREENING:
Patients who do not meet the above inclusion criteria will not receive leukapheresis
INCLUSION CRITERIA FOR TREATMENT:
INCLUSION CRITERIA - INITIAL ENROLLMENT
INCLUSION CRITERIA - MAINTENANCE THERAPY AFTER HSCT
In addition to the above, key inclusion and exclusion criteria are listed below.
INCLUSION CRITERIA FOR TRANSPLANT RECIPIENT
INCLUSION CRITERIA FOR HAPLOIDENTICAL DONOR
INCLUSION CRITERIA (ALL SUBJECTS)
INCLUSION CRITERIA (EXPANSION PHASE ONLY)
Concurrent treatment for cancer, with specific exceptions noted in inclusion criteria
Patient understands if he or she is randomized to receive molecularly guided treatment, they must meet all inclusion and exclusion criteria in the drug specific appendix for which they were randomized
Other protocol defined inclusion criteria could apply
Inclusion Criteria for Part 1 and Part 2
Other Inclusion criteria for Part 1
Other Inclusion criteria for Part 2
Inclusion Criteria for Part 3
The inclusion criteria for Part 3 will be based on emerging data from Parts 1 and 2 and will be specified in an amendment.
Other inclusion criteria may apply
Other protocol defined inclusion criteria may apply.
Other criteria apply.
Other criteria apply.
Other protocol-defined inclusion/exclusion criteria may apply.
GENERAL CRITERIA
All of the criteria listed above
All adverse events from the procedure have resolved or have been deemed irreversible and the patient meets inclusion criteria.
Other protocol defined criteria may apply
Key Inclusion Criteria:\n\n          -  Individuals in the primary Phase 3 study (Study GS-US-312-0116) who are compliant\n\n          -  Tolerating primary study therapy\n\n        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Other inclusion criteria may apply
PHASE II REGISTRATION - INCLUSION CRITERIA
Therapy with any other standard or investigational treatment for hematologic malignancy (except hydroxyurea, as mentioned in the inclusion criteria)
Can take oral med Part 2 Inclusion Criteria:
Can take oral med Part 3 Inclusion Criteria:
Meet at least one of the criteria below:
Can take oral med Part 4 Inclusion Criteria:
The clinical status of the patient at inclusion is one of the following:
Inclusion Criteria:\n\n        Exclusion Criteria:
COHORT 1 INCLUSION CRITERIA FOR APHERESIS/TUMOR BIOPSY PORTION OF THE TRIAL (closed to enrollment as of 6/22/13):
COHORT 1 INCLUSION CRITERIA FOR IMMUNOTHERAPY PORTION OF THE TRIAL (closed to enrollment as of 6/22/13):
COHORT 2 INCLUSION CRITERIA:
Standard safety inclusion for serum creatinine, AST, ALT, bilirubin
Must meet all inclusion and exclusion criteria
PRE-REGISTRATION INCLUSION CRITERIA
REGISTRATION INCLUSION CRITERIA
INCLUSION CRITERIA FOR SCREENING:
CRITERIA FOR LEUKAPHERESIS:
INCLUSION CRITERIA FOR TREATMENT:
INCLUSION CRITERIA FOR PHYSICIANS
INCLUSION CRITERIA FOR PATIENTS
Currently receiving (or scheduled to receive) radiation treatment for a cancer listed in the inclusion criteria
PATIENT INCLUSION: Have an identified caregiver who is also willing to participate
Inclusion Criteria:\n\n        For inclusion in the study, patients should fulfill the following criteria:\n\n          1. Aged at least 18 years.\n\n          2. Histologically or cytologically documented Stage IV NSCLC.\n\n          3. Confirmed tumor PD-L1 status prior to randomization.\n\n          4. Patients must have tumors that lack activating EGFR mutations and ALK fusions.\n\n          5. No prior chemotherapy or any other systemic therapy for metastatic NSCLC.\n\n          6. World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance\n             status of 0 or 1.\n\n          7. No prior exposure to immunemediated therapy, excluding therapeutic anticancer\n             vaccines.\n\n        Exclusion Criteria:\n\n        Patients should not enter the study if any of the following exclusion criteria are\n        fulfilled:\n\n          1. Mixed small-cell lung cancer and NSCLC histology, sarcomatoid variant.\n\n          2. Active or prior documented autoimmune or inflammatory disorders.\n\n          3. Brain metastases or spinal cord compression unless the patient's condition is stable\n             and off steroids.\n\n          4. Active infection including tuberculosis, hepatitis B, hepatitis C, or human\n             immunodeficiency virus.
INCLUSION CRITERIA FOR CROSSOVER THERAPY
PHASE I INCLUSION CRITERIA:
PHASE II INCLUSION CRITERIA:
PHASE III INCLUSION CRITERIA:
If they are not patients of Massey Cancer Center or do not meet the inclusion criteria listed above
INCLUSION CRITERIA-PATIENTS
INCLUSION CRITERIA-FCGs
INCLUSION CRITERIA FOR PARENTS: Parents of children who are aged 2-24 years
INCLUSION CRITERIA FOR PARENTS: Parents of children who have been diagnosed with new malignancy between 1-10 weeks prior
INCLUSION CRITERIA FOR PARENTS: Cognitively able to participate in interactive interviews
INCLUSION CRITERIA FOR PATIENTS: Child aged 2-24 years
INCLUSION CRITERIA FOR PATIENTS: Child who have been diagnosed with a new malignancy between 1-10 weeks prior
INCLUSION CRITERIA FOR PATIENTS: Child who are scheduled to receive cancer-directed therapy at Seattle Children's Hospital
Meet screening criteria
INCLUSION - STUDY 2: The inclusion/exclusion criteria follows similar criteria for study #1 except only patients with confirmed peripheral neuropathy (vibration perception threshold [VPT] big toe greater than 25 volt) will be included; patients who have completed clinical study 1 would be eligible for study 2 if develop CIPN as defined by VPT assessment
INCLUSION CRITERIA FOR PATIENT PARTICIPANTS
INCLUSION CRITERIA FOR CAREGIVER PARTICIPANTS
Caregiver inclusion criteria:\r\n* Adults (>= 21)\r\n* Family member or friend of an eligible patient
PARTNER: Female/male intimate partner of a young breast cancer survivor who meets the above YBCS inclusion criteria
ADDITIONAL CRITERIA
EXERCISE INCLUSION CRITERIA:
CROSSOVER RE-REGISTRATION - INCLUSION CRITERIA
Providing the majority of the informal (unpaid) care during RT for a patient meeting inclusion criteria
Children who do not meet the above criteria
Meet screening criteria
INCLUSION CRITERIA FOR FOCUS GROUPS (PHASE I)
INCLUSION CRITERIA FOR PILOT-TESTING (PHASE II)
STRATEGISTS INCLUSION CRITERIA
Blood transfusion to meet the inclusion criteria will not be allowed
PATIENT INCLUSION CRITERIA:
CAREGIVER INCLUSION CRITERIA:
Meet all inclusion criteria above
Ready to use reliable contraceptive procedures Inclusion Criteria Specific to HCC (Arm A and Arm F):
Antiviral therapy per local standard-of-care if active hepatitis B virus (HBV) Inclusion Criteria Specific to Arm A (Patients must also meet all of the following specific inclusion criteria to be eligible for enrollment in Arm A:)
Anti-viral therapy per local standard-of-care if active hepatitis B virus (HBV). Inclusion Criteria Specific to Arm F (Patients must also meet all of the following specific inclusion criteria to be eligible for enrollment in Arm F:)
Anti-viral therapy per local standard-of-care if active hepatitis B virus (HBV). Inclusion Criteria Specific to Gastric Cancer (Arm B) (Patients must also meet all of the following specific inclusion criteria to be eligible for enrollment in Arm B:)
Absence of HER2 expression documented as in situ hybridization (ISH) negative on previously collected and assessed tumor tissue upon initial diagnosis of disease Inclusion criteria specific to metastatic pancreatic cancer (Arm C) (Patients must also meet all of the following specific inclusion criteria to be eligible for enrollment in Arm C:)
No previous radiotherapy, surgery, chemotherapy, or investigational therapy for the treatment of metastatic disease Inclusion Criteria Specific to mEC (Arm E) (Patients must also meet all of the following specific inclusion criteria to be eligible for enrollment in Arm E:)
ECOG ? 3 Phase 2 Inclusion Criteria:
INCLUSION CRITERIA FOR GROUP 2A AND 2B
INCLUSION CRITERIA-PATIENTS
INCLUSION CRITERIA-CAREGIVERS
Patients who will be enrolled on the observational arm should meet the 2nd, 3rd, and 4th inclusion criteria only
INCLUSION CRITERIA FOR PATIENTS: Admitted to 6E with suspected or actual new diagnosis of leukemia or lymphoma within the past 24 hours
INCLUSION CRITERIA FOR PATIENTS: Completed education to at least the 6th grade level
INCLUSION CRITERIA FOR PATIENTS: No significant auditory or visual deficits with corrective devices
INCLUSION CRITERIA FOR PATIENTS: Physiologically stable
INCLUSION CRITERIA FOR PATIENTS: Not at end of life
INCLUSION CRITERIA FOR PATIENTS: No alterations in mental status
INCLUSION CRITERIA FOR FAMILY MEMBERS: Willing to view DVD and read education booklet
INCLUSION CRITERIA FOR FAMILY MEMBERS: Selected by patient to participate
INCLUSION CRITERIA FOR FAMILY MEMBERS: English speaking
INCLUSION CRITERIA FOR FAMILY MEMBERS: No significant auditory or visual deficits with corrective devices
INCLUSION CRITERIA FOR FAMILY MEMBERS: No alterations in mental status
INCLUSION CRITERIA FOR FAMILY MEMBERS: Completed education to at least the 6th grade level
Using the same inclusion criteria as Stage 1 a convenience sample of 30 different HNC survivors will be recruited
GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: NOTE: patient does not need to meet all subprotocol criteria at time of enrollment onto the APEC1621 screening protocol, but will need to meet all criteria prior to enrollment on any assigned treatment subprotocol; patients must be enrolled onto a subprotocol within 8 weeks (56 days) of treatment assignment
GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age
All other postmenopausal women are eligible for inclusion in the biennial screening regimen
READER STUDY INCLUSION
REGULATORY CRITERIA
PRE-REGISTRATION-INCLUSION CRITERIA
REGISTRATION/RANDOMIZATION INCLUSION CRITERIA:
PRE-REGISTRATION INCLUSION
REGISTRATION INCLUSION
PRE-REGISTRATION INCLUSION:
REGISTRATION INCLUSION:
Meets all inclusion criteria outlined in Aim 1
PRE-REGISTRATION INCLUSION CRITERIA
REGISTRATION INCLUSION CRITERIA
Laboratory (lab) results do not meet inclusion criteria
PRE-REGISTRATION INCLUSION CRITERIA
REGISTRATION INCLUSION CRITERIA
Any lab results that do not meet inclusion criteria after the Screen 1 blood tests
INCLUSION CRITERIA FOR ENROLLMENT (PRE-TRANSPLANT)
INCLUSION CRITERIA (PRIOR TO IBRUTINIB ADMINISTRATION)
DONOR INCLUSION CRITERIA
PRE-REGISTRATION INCLUSION CRITERIA
REGISTRATION/RANDOMIZATION INCLUSION CRITERIA
Inclusion criteria for screening RPFNA
Inclusion criteria for intervention phase
DRIVERS INCLUSION CRITERIA
IF PROTOCOL 2546 SERVES AS AN ADJUNCT PROTOCOL, THE PATIENTS ONLY NEEDS TO MEET INCLUSION CRITERIA 1 THROUGH 5A
Patient plans to receive concurrent chemotherapy, other than the regimens specified in the inclusion criteria
Other protocol-defined inclusion/exclusion criteria may apply
Subject presenting with bilateral breast cancer may be enrolled if BOTH cancers meet all of the inclusion and none of the exclusion criteria
Additional Inclusion Criteria Specific for Arm A:
Additional Inclusion Criteria Specific for Arm B:
Additional Inclusion Criteria Specific for Arm C:
PRE-REGISTRATION INCLUSION CRITERIA
REGISTRATION INCLUSION CRITERIA
Inclusion Criteria:\n\n          -  referrals from the New York State Smokers' Quitline\n\n          -  at least 18 years of age
Patients failing to meet the inclusion criteria
GENERAL INCLUSION CRITERIA
Subjects who do not meet the above mentioned inclusion criteria
One of the following inclusion criteria must be true for patient to be eligible for enrollment:
INCLUSION CRITERIA (INITIAL 10 PATIENTS WITH METASTATIC PROSTATE CANCER)
HEALTHY VOLUNTEERS (Group 4): Must meet inclusion criteria for “all participants” described above
INCLUSION CRITERIA: MEN WITH UNTREATED PROSTATE CANCER
INCLUSION CRITERIA: FOR MEN WITH PRESUMED PROSTATE CANCER RELAPSE
INCLUSION CRITERIA FOR OPEN-ACCESS: All participants under the care of St. Jude physicians with known or suspected neoplastic disease are eligible for participation
INCLUSION CRITERIA FOR OPEN-ACCESS: Female participants of childbearing age must not be lactating
INCLUSION CRITERIA FOR ORAL LESION AND NORMAL TISSUE
INCLUSION CRITERIA FOR DRY MOUTH STUDY
INCLUSION CRITERIA FOR GUM STUDY
Inclusion criteria for Aim 1:
Inclusion criteria for Aim 2:
Biopsy does not meet inclusion criteria
Other protocol defined inclusion criteria could apply
All subjects enrolled into either Part 1 or Part 2 must meet all of the following inclusion criteria to be eligible:
Subject must give written informed consent. Part B, Inclusion criteria All inclusion criteria as for Part A, except for inclusion criterion 2 which is replaced by:
STEP 1: INCLUSION CRITERIA FOR TUMOR COLLECTION
Other Inclusion Criteria May Apply
Completed and documented history and physical addressing all inclusion/exclusion criteria
Previous inclusion in the current study
Common inclusion criterion
Inclusion criterion for normal cohort
INCLUSION CRITERIA - FOR MALE COHORT
INCLUSION CRITERIA - FOR NORMAL HEALTHY FEMALE COHORT: Good health conditions or without significant diseases, according to best medical judgement
INCLUSION CRITERIA - FOR NORMAL HEALTHY FEMALE COHORT: If breastfeeding, must be willing to discard breastmilk for 24 hours following zolpidem
INCLUSION CRITERIA - FOR NORMAL HEALTHY FEMALE COHORT: Ability to swallow study medication
HEALTHY VOLUNTEER INCLUSION CRITERIA:
PANCREATIC CANCER PATIENT INCLUSION CRITERIA:
SITE INCLUSION CRITERIA:
PATIENT INCLUSION CRITERIA:
CLINICIAN PARTICIPANTS INCLUSION CRITERIA:
PATIENT PARTICIPANTS INCLUSION CRITERIA:
GARAGE INCLUSION:
DRIVER INCLUSION:
Not currently receiving radiation treatment for a cancer listed in the arm-specific inclusion criteria (Arms 2 and 3)
TRIAL INCLUSION:
PATIENT INCLUSION:
HEALTH CARE PROVIDER INCLUSION CRITERIA:
CHART AUDIT INCLUSION CRITERIA (BASELINE):
CHART AUDIT INCLUSION CRITERIA (POST-INTERVENTION)
Criteria 10, Other Inclusion Criteria May Apply.
Other Inclusion Criteria May Apply
Other Protocol defined Inclusion/Exclusion may apply.
Cohort 4 (severe): Bilirubin > 3 × ULN; any AST Exception to Inclusion Criterion #5 for Subjects with Normal Hepatic Function: All subjects enrolled with normal hepatic function (N=10) must meet all inclusion criteria as outlined with the exception of Inclusion Criterion #5, which should be substituted with the following criterion to be enrolled into the study: