Patients treated with prior surgery are eligible for this study if they otherwise meet eligibility criteria
Patients must be considered to be suitable RIC alloHCT candidates at the time of enrollment based on medical history, physical examination, and available laboratory tests. Specific testing for organ function is not required for eligibility but, if available, these tests should be used to judge eligibility.
ELIGIBILITY FOR STRATUM S PATIENTS TO START MAINTENANCE CHEMOTHERAPY
ELIGIBILITY FOR STRATUM S PATIENTS TO START MAINTENANCE CHEMOTHERAPY:
Histology slides reviewed and agreement between two clinical pathologists (not required to be at same institution) that pathology fulfills COMET eligibility criteria. In cases of disagreement between the two pathology reviews about whether or not a case fulfills the eligibility criteria, a third pathology review will be required.
ELIGIBILITY CRITERIA FOR SCREENING AND MOLECULAR PROFILING (STEP 0)
PRE-REGISTRATION ELIGIBILITY CRITERIA
REGISTRATION ELIGIBILITY CRITERIA
PRE-REGISTRATION ELIGIBILITY CRITERIA:
REGISTRATION ELIGIBILITY CRITERIA:
Re-registration Eligibility Criteria (for patients who crossover from arm 1 nivolumab alone to dual agent nivolumab and ipilimumab upon progression)
REGISTRATION STEP 2-RANDOMIZATION: Patients must be eligible for at least one of the currently active investigational treatment arms (S1612B or S1612C); if the patient does not meet eligibility criteria for at least one active investigational arm, then the patient is not eligible for S1612
Eligibility criteria to participate in group 1 of the pilot study of the AYA-Hears instrument \r\nNote: participants in group 1 will not receive protocol-directed therapy
NaF PET/CT OPTIONAL SUB-STUDY ELIGIBILITY CRITERIA
POST-INDUCTION THERAPY ELIGIBILITY CRITERIA (PRIOR TO INTENSIFICATION-STEP 2)
Patients should meet the eligibility criteria for RANDOMIZATION TO BLINATUMOMAB OR NO BLINATUMOMAB-STEP 3
ELIGIBILITY FOR CHEMOTHERAPY COHORT:
ELIGIBILITY FOR NON-CHEMOTHERAPY COHORT:
Eligibility criteria for the National Cancer Institute (NCI) standard risk patients from AALL0932 enrolling on this study at the end of Induction
No platelet transfusions within 7 days of registration to meet eligibility criteria; Note: red blood cell transfusions are allowed at any time
Note: G-CSF and platelet transfusions cannot be used to increase counts to meet eligibility criteria
RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Patients randomized to Arm 1 may opt to switch to the 3-drug regimen following disease progression; these patients must be re-registered to the study and meet the eligibility criteria below
RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Note: G-CSF and platelet transfusions cannot be used to increase counts to meet eligibility criteria
ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C): No evidence of isolated extramedullary relapse (i.e., testicular or central nervous system [CNS])
ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C): Patient must not have Burkitt’s lymphoma/leukemia based on the World Health Organization (WHO) criteria
ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C): Patients must not be participating in any other clinical trial or taking any other experimental medications within 21 days prior to registration
ELIGIBILITY CRITERIA - PHASE II (ARM D): ECOG performance status 0-2
ELIGIBILITY CRITERIA - PHASE II (ARM D): Adequate liver function with AST/ALT less than 3 X upper limit of normal and total bilirubin less than 2 mg/dL within 7 days prior to first dose of study agent
ELIGIBILITY CRITERIA - PHASE II (ARM D): Circulating WBC count must not be above 20 x10^9/L within 7 days prior to first dose of study agent\r\n* Patients with WBC count above 20 x10^9/L may be eligible if they start steroids or hydroxyurea per institutional guidelines, but they must discontinue before day 1 of study drug
ELIGIBILITY CRITERIA - PHASE II (ARM D): No evidence of isolated extramedullary relapse (i.e., testicular or CNS)
ELIGIBILITY CRITERIA - PHASE II (ARM D): Patient must not have Burkitt’s lymphoma/leukemia based on the WHO criteria
ELIGIBILITY CRITERIA - PHASE II (ARM D): Patients must not be participating in any other clinical trial or taking any other experimental medications within 21 days prior to registration
Evaluation by an attending thoracic surgeon to confirm eligibility for an R0 resection with curative intent
ELIGIBILITY FOR SCREENING
NOTE: platelet transfusions to help patients meet eligibility criteria are not allowed within 3 days before registration
CRITERIA FOR DONOR ELIGIBILITY:
ELIGIBILITY CRITERIA FOR ENROLLMENT
Prior eligibility for and on study treatment from an antecedent vemurafenib protocol
Pre-registration Eligibility Inclusion Criteria for the PIK3CA Mutant Cohort (closed 03/17/2016)
Platelet transfusions to help patients meet eligibility criteria are not allowed within 3 days before study enrollment
Absolute neutrophil count (ANC) >= 1,000/mm^3; platelet transfusions to help patients meet eligibility criteria are not allowed within 3 days before study enrollment; patients may receive growth factor support prior to initiating therapy but must remain off of growth factor for at least 7 days before starting therapy and must meet eligibility on cycle 1, day 1; patients who complete the consent process but do not meet hematologic eligibility within 30 days may be re-consented and enrolled on study if they ultimately do meet eligibility requirements before day +180; no patients may initiate therapy after day +180 and they must meet all remaining eligibility criteria
NOTE: Patients are expected to initiate therapy as close to day +100 as possible; no patient may initiate therapy before day +70 and initiation of therapy beyond day +130 is allowed ONLY for patients who meet all eligibility criteria except for hematologic parameters, in which case patients may be delayed until their hematologic laboratories meet criteria but no later than day +180; regardless of the time of therapy initiation, patients must meet all eligibility criteria and must have completed all consent documentation and screening procedures within the specified window
INCLUSION CRITERIA FOR STRATUM C: Patients must have received prior radiotherapy and/or chemotherapy with the following exceptions:\r\n* Patients with secondary CNS cancers after a previous medical problem/malignancy who cannot receive full dose of radiotherapy (> 50 Gy) as long as they meet all other eligibility criteria\r\n* Patients with progressive low-grade gliomas and CMMRD or Lynch syndrome\r\nPatients must have recovered from the acute treatment related toxicities (defined as =< grade 1 if not defined in eligibility criteria) of all prior chemotherapy, immunotherapy or radiotherapy prior to entering this study; there is no upper limit to the number of prior therapies that is allowed
ELIGIBILITY CRITERIA AT TIME OF TREATMENT: EBV positive tumor
ELIGIBILITY CRITERIA AT TIME OF TREATMENT: Hemoglobin (Hgb) > 8.0 (may be a transfused value)
ELIGIBILITY CRITERIA AT TIME OF TREATMENT: Patients should have been off other investigational therapy for 30 days prior to infusion
Meet the following laboratory parameters, per the reference range, at least once during the screening period: ANC of at least 1000/?L (Subjects may use growth factor support to achieve ANC eligibility criteria), AST and ALT not higher than 3 x ULN, Calculated creatinine clearance of at least 30 mL/min using a modified Cockcroft-Gault calculation, platelet count of at least 30,000 mm³ (independent of transfusion for 2 weeks), hemoglobin of at least 8.0 g/dL (subjects may receive blood transfusion to achieve hemoglobin eligibility criteria), and total bilirubin not higher than 1.5 x ULN (subjects with Gilbert's Syndrome may have bilirubin higher 1.5 x ULN).
MANUFACTURING SJCAR19: Meets eligibility criteria to undergo autologous apheresis, or have previously undergone autologous apheresis
Patient re-enrollment: This study permits the re-enrollment of a patient that has discontinued the study as a screen failure (ie, patient has not been dosed/has not been treated); if re-enrolled, the patient must be re-consented and satisfy all eligibility criteria
Eligibility for Infusion of Investigational Product:\r\n* Subjects will undergo a second evaluation of eligibility on day -2 or -1 prior to infusion of anti-CD19 CAR-T cell product. This eligibility criterion will include the inclusion and exclusion criteria required for enrollment with the following exceptions and additions.\r\n** Inclusion criteria exceptions: Hematologic function parameters will not be included as a pre-infusion eligibility criterion (because lymphodepletive chemotherapy is expected to cause pancytopenia).
Eligibility for Infusion of Investigational Product:\r\n* Subjects will undergo a second evaluation of eligibility on day -2 or -1 prior to infusion of anti-CD19 CAR-T cell product. This eligibility criterion will include the inclusion and exclusion criteria required for enrollment with the following exceptions and additions.\r\n* Exclusion criteria additions:\r\n** Use of corticosteroids within 7 days prior to infusion (with exception of agents used for prevention of emesis during lymphodepletive chemotherapy).\r\n** Neurologic symptoms suggestive of an active central nervous system condition.\r\n** Signs or laboratory markers of active infection or systemic inflammatory response.
Participants must meet appropriate molecular eligibility criteria
ADDITIONAL COHORT 1 ELIGIBILITY CRITERIA
ADDITIONAL COHORT 2 ELIGIBILITY CRITERIA
ELIGIBILITY TO PROCEED WITH PERIPHERAL BLOOD MONONUCLEAR CELL (PBMC) COLLECTION
ELIGIBILITY TO PROCEED WITH RICKHAM PLACEMENT\r\n* Once research participants meet eligibility to proceed with Rickham placement, they will be deemed accrued on to the study
ELIGIBILITY TO PROCEED WITH CAR T CELL INFUSION
Imaging evaluations necessary to establish eligibility for study entry must be done within three (3) weeks prior to registration
All other evaluations necessary to establish eligibility for study entry must be done within two (2) weeks prior to registration
ELIGIBILITY CRITERIA FOR ENROLLMENT ON THE RE-TREATMENT STUDY
Active genital infection at the time of enrollment (if present initially, can be treated and then patient can be re-evaluated for eligibility)
ELIGIBILITY FOR LYMPHODEPLETION CHEMOTHERAPY AND T CELL INFUSION
History of transfusion is acceptable and transfusions may be given to meet eligibility requirements
REP ELIGIBILITY: Has not had a partial or complete response to nivolumab treatment
CHEMOTHERAPY/CELL INFUSION ELIGIBILITY: Clinical performance status equivalent to ECOG 0-1 at the clinical visit prior to lymphodepletion
CHEMOTHERAPY/CELL INFUSION ELIGIBILITY: Urinalysis within 14 days demonstrating that no urinary tract infection is present
PRE-SCREENING ELIGIBILITY
Subject meets standard of care eligibility criteria for consideration of treatment with immunotherapy using a checkpoint inhibitor following surgical resection
STUDY TREATMENT ELIGIBILITY
AT SCREENING: Hemoglobin within institutional normal limits. Administration of growth factors or blood transfusions will not be allowed to confirm eligibility.
AT SCREENING: Platelet count within institutional normal limits. Administration of growth factors or blood transfusions will not be allowed to confirm eligibility.
AT SCREENING: Absolute neutrophil count within institutional normal limits. Administration of growth factors or blood transfusions will not be allowed to confirm eligibility.
AT SCREENING: Absolute lymphocyte count within institutional normal limits. Administration of growth factors or blood transfusions will not be allowed to confirm eligibility.
Any patient not meeting institutional standard guidelines for transplant eligibility
Eligibility criteria for additional lines of MTB recommended targeted therapy:\r\n* Patient’s disease has progressed on the first line (or previous line) of MTB recommended targeted therapy or patient could not tolerate the targeted treatment\r\n* Patients must meet eligibility criteria as defined previously
PRE-ASCT ELIGIBILITY CRITERIA
ELIGIBILITY CRITERIA TO BEGIN CONSOLIDATION THERAPY
FULL STUDY INCLUSION CRITERIA: Hemoglobin (Hb) >= 8 g/dL, without blood transfusion or erythropoietin within 6 weeks before the start of study treatment\r\n* Note: patients receiving chronic low-dose erythropoietin for chronic renal failure are allowed provided no dose adjustment is undertaken within 6 weeks before signing consent for full study and until safety follow-up visit and provided that they fulfill conditions of eligibility criteria
Patients must meet eligibility in at least 1 of the following 6 groups:
CROSS-OVER ELIGIBILITY CRITERIA
Platelets >= 100,000 /mcL in the absence of transfusion support within 7 days of determining eligibility
Transfusions intended to elevate any parameters below solely for the intent of meeting study eligibility are not permitted
PRE-REGISTRATION ELIGIBILITY
REGISTRATION ELIGIBILITY CRITERIA
Patients for the expansion cohort must have a CTC (TelomeScan) drawn in the screening phase if other eligibility criteria are met, and must be CTC-positive in order to be eligible for enrollment in the expansion cohort
Transfusions are not allowed to meet eligibility criteria
Most recent HR and HER2 receptor testing should be used to determine eligibility.
DONOR: Regarding donation eligibility, is identified as either:\r\n* Completed the process of donor eligibility determination as outlined in 21 Code of Federal Regulations (CFR) 1271 and agency guidance; OR\r\n* Does not meet 21 CFR 1271 eligibility requirements, but has a declaration of urgent medical need completed by the principal investigator or physician sub-investigator per 21 CFR 1271
ELIGIBILITY FOR TREATMENT WITH TCRC4-TRANSDUCED CD8+ CELLS
ELIGIBILITY FOR OBSERVATION ARM
PRE-REGISTION ELIGIBILITY
REGISTRATION ELIGIBILITY
ELIGIBILITY CRITERIA FOR nEGFR TESTING
ELIGIBILITY CRITERIA FOR STUDY THERAPY
Any number of prior therapies as long as patients have adequate performance status and meet all other eligibility criteria
Must meet eligibility criteria for initiation of part A with the exception of being allowed to have prior nivolumab in part A of this protocol
PHASE I STUDY ELIGIBILITY CRITERIA:\r\nAll patients must have evaluable disease; biomarker-only disease is not considered evaluable; eligibility of breast cancer with bone only disease is a principal investigator (PI) decision on an individual patient basis
PHASE I STUDY ELIGIBILITY CRITERIA:\r\nAbsolute neutrophil count >= 1,500/mcL
PHASE I STUDY ELIGIBILITY CRITERIA: \r\nWhite blood cell (WBC) >= 3,000/mcL
PHASE I STUDY ELIGIBILITY CRITERIA:\r\nPlatelets >= 100,000/mcL
PHASE I STUDY ELIGIBILITY CRITERIA:\r\nAbility of subject to understand and the willingness to record twice-daily blood pressure readings if the patient is enrolled to the MEDI+C arm or MEDI+O+C arm
PHASE I STUDY ELIGIBILITY CRITERIA:\r\nPatients who were treated with both olaparib and cediranib, either in combination or sequentially
PHASE I STUDY ELIGIBILITY CRITERIA:\r\nMajor surgical procedure (as defined by the investigator) within 30 days prior to the first dose of MEDI4736 or still recovering from prior surgery
PHASE I STUDY ELIGIBILITY CRITERIA:\r\nHistory of auto-immune disease requiring steroid maintenance, or history of primary immunodeficiency
PHASE I STUDY ELIGIBILITY CRITERIA:\r\nReceipt of live attenuated vaccination within 30 days before the first dose of MEDI4736
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)
PHASE I STUDY ELIGIBILITY CRITERIA:\r\nCurrent signs and/or symptoms of bowel obstruction or signs and/or symptoms of bowel obstruction within 28 days before study enrollment
PHASE I STUDY ELIGIBILITY CRITERIA:\r\nCurrent dependency on total parenteral nutrition (TPN) or IV fluid hydration
PHASE I STUDY ELIGIBILITY CRITERIA:\r\nPregnant and breastfeeding women are excluded from this study
PHASE I STUDY ELIGIBILITY CRITERIA:\r\nKnown history of previous clinical diagnosis of tuberculosis
PHASE I STUDY ELIGIBILITY CRITERIA:\r\nNo baseline features suggestive of myelodysplastic syndrome or acute myelogenous leukemia on peripheral blood smear or bone marrow biopsy, if clinically indicated
PHASE I STUDY ELIGIBILITY CRITERIA:\r\nConcurrent enrollment in another clinical study, unless it is an observational non-interventional clinical study or the follow-up of an interventional study
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C): Patients must have measurable disease as defined by RECIST v1.1
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C): Patients must have at least one lesion deemed safe to biopsy and be willing to undergo a mandatory baseline biopsy
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C): ECOG performance status =< 2
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C): Absolute neutrophil count >= 1,500/mcL
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C): White blood cell (WBC) >= 3,000/mcL
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C): Platelets >= 100,000/mcL
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C): Hemoglobin (Hgb) >= 9 g/dL in the absence of packed red blood cell transfusion 28 days prior to dosing
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C): AST(SGOT)/ALT(SGPT) =< 2.5 X institutional upper limit of normal (ULN); for subjects with liver metastases, AST or ALT =< 5 X ULN
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C): Total bilirubin =< 1.5 X ULN; for subjects with documented/suspected Gilbert's disease, bilirubin =< 3 X ULN
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C): Creatinine =< 1.5 X within normal institutional limits OR measured creatinine clearance >= 50 mL/min/1.73 m^2
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C): For OvCa MEDI+C and MEDI+O+C arms only: \r\nSpot urine protein/creatinine ratio =< 1 OR 24 hour urine protein =< 1000 mg
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C): Patients are allowed to have received prior PARP inhibitors (PARPi), and/or anti-angiogenesis therapy including but not limited to thalidomide, bevacizumab, sunitinib, sorafenib, or other anti-angiogenics; however, patients who were treated with both olaparib and cediranib, either in combination or sequentially are not eligible; for this study, BSI-201 (iniparib) is not considered as PARPi
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C): \r\nPatients must be able to swallow oral medications (capsules and tablets) without chewing, breaking, crushing, opening or otherwise altering the product formulation; they should not have gastrointestinal illnesses that would preclude the absorption of cediranib or olaparib, which are oral agents
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C): Adequately controlled blood pressure (SBP < 140 mmHg and DBP < 90 mmHg) on a maximum of three anti-hypertensive medications
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C): Toxicities of prior therapy (excepting alopecia) should be resolved to less than or equal to grade 1 as per CTCAE v 4.03 except hemoglobin; patients with long-standing stable grade 2 neuropathy may be considered after discussion with the PI
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C): \r\nAbility of subject to understand and the willingness to sign a written informed consent document prior to any protocol related procedures, including screening evaluations
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C): Ability of subject to understand and the willingness to record twice-daily blood pressure readings if the patient is enrolled to the MEDI+C or MEDI+O+C arm
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nPatients who have received chemotherapy, radiotherapy, any other investigational agents within 3 weeks (4 weeks for platinum agents and 6 weeks for nitrosoureas or mitomycin) prior to study enrollment
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nPatients who were treated with both olaparib and cediranib, either in combination or sequentially
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nPatients who have had prior immune checkpoint inhibitors, such as MEDI4736 or other PD1 or PD-L1 inhibitors or an anti-CTLA4 therapy
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nPatients receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 are ineligible; dihydropyridine calcium-channel blockers are permitted for management of hypertension
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nMajor surgical procedure (as defined by the investigator) within 30 days prior to the first dose of MEDI4736 or still recovering from prior surgery
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nHistory of allergic reactions attributed to compounds of similar chemical or biologic composition to MEDI4736, olaparib, cediranib, or to other humanized monoclonal antibodies; known history of anaphylaxis, angioedema, laryngeal edema, serum sickness, or uncontrolled asthma
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nHistory of auto-immune disease requiring steroid maintenance, or history of primary immunodeficiency
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nReceipt of live attenuated vaccination within 30 days before the first dose of MEDI4736
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nHistory of cerebrovascular accident, transient ischemic attack within 1 year prior to study enrollment
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nSignificant hemorrhage (> 30 mL bleeding/episode within 3 months before study enrollment) or haemoptysis (> 5 mL fresh blood within 28 days before study enrollment)
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nCurrent signs and/or symptoms of bowel obstruction or signs and/or symptoms of bowel obstruction within 28 days before study enrollment
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nCurrent dependency on TPN or IV fluid hydration
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nPregnant and breastfeeding women are excluded from this study
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nHIV-positive patients on antiretroviral therapy are ineligible; however, patients with long-standing (> 5 years) HIV on antiretroviral therapy > 1 month (undetectable HIV viral load and CD4 count > 150 cells/uL) may be eligible if the PI determines no anticipated clinically significant drug-drug interactions
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nHBV- or HCV-positive patients are ineligible
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nKnown history of previous clinical diagnosis of tuberculosis
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nNo baseline features suggestive of myelodysplastic syndrome or acute myelogenous leukemia on peripheral blood smear or bone marrow biopsy, if clinically indicated
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nNo prior or current evidence of coagulopathy or bleeding diathesis; therapeutic anti-coagulation for prior thromboembolic events is permitted
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nConcurrent enrollment in another clinical study, unless it is an observational noninterventional clinical study or the follow-up of an interventional study
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nAny concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment; concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable; NOTE: Local treatment of isolated lesions for palliative intent is acceptable (e.g., by local surgery or radiotherapy)
PHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY)\r\nPatients must have measurable disease as defined by RECIST v1.1
PHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nPatients must have at least one lesion deemed safe to biopsy and be willing to undergo a mandatory baseline biopsy
PHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nECOG performance status =< 2
PHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nAbsolute neutrophil count >= 1,500/mcL
PHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nWhite blood cell (WBC) >= 3,000/mcL
PHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nPlatelets >= 100,000/mcL
PHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nHemoglobin (Hgb) >= 9 g/dL in the absence of packed red blood cell transfusion 28 days prior to dosing
PHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nAST(SGOT)/ALT(SGPT) =< 2.5 X institutional upper limit of normal (ULN); for subjects with liver metastases, AST or ALT =< 5 × ULN
PHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nTotal bilirubin =< 1.5 × ULN; for subjects with documented/suspected Gilbert’s disease, bilirubin =< 3 × ULN
PHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nCreatinine =< 1.5 X within normal institutional limits OR measured creatinine clearance >= 50 mL/min/1.73 m^2
PHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nToxicities of prior therapy (excepting alopecia) should be resolved to less than or equal to grade 1 as per CTCAE v 4.03 except hemoglobin; patients with long-standing stable grade 2 neuropathy may be considered after discussion with the PI
PHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nAbility of subject to understand and the willingness to sign a written informed consent document prior to any protocol related procedures, including screening evaluations
PHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nPatients who have received prior PARP inhibitors (PARPi) are ineligible; for this study, BSI-201 (iniparib) is not considered as PARPi
PHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nPatients who have had prior immune checkpoint inhibitors, such as MEDI4736 or other PD1 or PD-L1 inhibitors or an anti-CTLA4 therapy
PHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nPatients receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 are ineligible; dihydropyridine calcium-channel blockers are permitted for management of hypertension
PHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nMajor surgical procedure (as defined by the investigator) within 30 days prior to the first dose of MEDI4736 or still recovering from prior surgery
PHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nHistory of allergic reactions attributed to compounds of similar chemical or biologic composition to MEDI4736, olaparib or to other humanized monoclonal antibodies; known history of anaphylaxis, angioedema, laryngeal edema, serum sickness, or uncontrolled asthma
PHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nHistory of auto-immune disease requiring steroid maintenance, or history of primary immunodeficiency
PHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nReceipt of live attenuated vaccination within 30 days before the first dose of MEDI4736
PHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nHistory of cerebrovascular accident, transient ischemic attack within 1 year prior to study enrollment
PHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nSignificant hemorrhage (> 30 mL bleeding/episode within 3 months before study enrollment) or haemoptysis (> 5 mL fresh blood within 28 days before study enrollment)
PHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nCurrent dependency on TPN or IV fluid hydration
PHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nPregnant and breastfeeding women are excluded from this study
PHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nHBV or HCV-positive patients are ineligible
PHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nKnown history of previous clinical diagnosis of tuberculosis
PHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nNo baseline features suggestive of myelodysplastic syndrome or acute myelogenous leukemia on peripheral blood smear or bone marrow biopsy, if clinically indicated
PHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nNo prior or current evidence of coagulopathy or bleeding diathesis; therapeutic anticoagulation for prior thromboembolic events is permitted
PHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nConcurrent enrollment in another clinical study, unless it is an observational non-interventional clinical study or the follow up of an interventional study
PHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nFor MEDI+C NSCLC arm only, adequately controlled blood pressure (SBP < 140 mm Hg and DBP < 90 mmHg) on a maximum of three antihypertensive medications
PHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nAbility of subject to understand and the willingness to record twice-daily blood pressure readings if the patient is enrolled to the MEDI+C arm (NSCLC patients only)
PHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nSpecific criteria for the SCLC cohort:\r\nHistologically or cytologically confirmed SCLC with at least one prior line of platinum-based chemotherapy are eligible; patients with both platinum-sensitive and platinum-refractory disease will be eligible
PHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nPresence of measurable disease as defined by RECIST v1.1
PHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nPatients must have at least one lesion deemed safe to biopsy and be willing to undergo a mandatory baseline biopsy
PHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nECOG performance status =< 2
PHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nAbsolute neutrophil count >= 1,500/mcL
PHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nWhite blood cell (WBC) >= 3,000/mcL
PHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nPlatelets >= 100,000/mcL
PHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nHemoglobin (Hgb) >= 9 g/dL in the absence of packed red blood cell transfusion 28 days prior to dosing
PHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nAST(SGOT)/ALT(SGPT) =< 2.5 X institutional ULN; for subjects with liver metastases, AST or ALT =< 5 × ULN
PHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nTotal bilirubin =< 1.5 X ULN; for subjects with documented/suspected Gilbert`s disease, bilirubin =< 3 X ULN
PHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nCreatinine =< 1.5 X within normal institutional limits OR measured creatinine clearance >= 50 mL/min/1.73 m^2
PHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nFor NSCLC cohort MEDI+C arm only:\r\nSpot urine protein/creatinine ratio =< 1 OR 24 hour urine protein =< 1000 mg
PHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nPatients who have received anti-angiogenesis therapy are eligible, including but not limited to thalidomide, bevacizumab, sunitinib, sorafenib, or other anti-angiogenics; however, patients who were treated with cediranib, either in combination or monotherapy are not eligible
PHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nPatients must be able to swallow oral medications (capsules and tablets) without chewing, breaking, crushing, opening or otherwise altering the product formulation; they should not have gastrointestinal illnesses that would preclude the absorption of cediranib or olaparib, which are oral agents
PHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nToxicities of prior therapy (excepting alopecia) should be resolved to less than or equal to grade 1 as per CTCAE v 4.03 except hemoglobin; patients with long-standing stable grade 2 neuropathy may be considered after discussion with the PI
PHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nAbility of subject to understand and the willingness to sign a written informed consent document prior to any protocol related procedures, including screening evaluations
PHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nPatients who have had prior PARP inhibitors; for this study, BSI-201 (iniparib) is not considered as PARPi
PHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nPatients who have received chemotherapy, radiotherapy any other investigational agents within 3 weeks (6 weeks for nitrosoureas or mitomycin) prior to study enrollment are ineligible with the following exceptions:\r\n* SCLC patients who have received radiation therapy within 14 days before the first dose of study treatment\r\n* NSCLC patients who have received erlotinib, afatinib, osimertinib, crizotinib, or ceritinib within 14 days of the first dose of study treatment
PHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nPatients receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 are ineligible; dihydropyridine calcium-channel blockers are permitted for management of hypertension
PHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nMajor surgical procedure (as defined by the investigator) within 30 days prior to the first dose of MEDI4736 or still recovering from prior surgery
PHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nPatients with history of a previous malignancy within the last 2 years are ineligible, except non-melanoma skin cancer, papillary carcinoma of the thyroid or non-invasive cancer of the uterine cervix; eligibility of SCLC patients with inactive prior malignancy is a PI decision on an individual patient basis
PHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nHistory of allergic reactions attributed to compounds of similar chemical or biologic composition to MEDI4736, olaparib, cediranib, or to other humanized monoclonal antibodies; known history of anaphylaxis, angioedema, laryngeal edema, serum sickness, or uncontrolled asthma
PHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nHistory of auto-immune disease requiring steroid maintenance, or history of primary immunodeficiency
PHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nPatients with prior history of pneumonitis and/or interstitial lung disease will be excluded
PHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nActive or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis); eligibility for patients with asymptomatic and a previous diagnosis of immune or inflammatory colitis, or patients with chronic diarrhea > 1 month without immune or inflammatory colitis is a PI decision on an individual patient basis
PHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nReceipt of live attenuated vaccination within 30 days before the first dose of MEDI4736
PHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nHistory of cerebrovascular accident, transient ischemic attack within 1 year prior to study enrollment
PHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nHistory of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment
PHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nSignificant hemorrhage (> 30 mL bleeding/episode within 3 months before study enrollment) or hemoptysis (> 5mL fresh blood within 28 days before study enrollment)
PHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nCurrent signs and/or symptoms of bowel obstruction or signs and/or symptoms of bowel obstruction within 28 days before study enrollment
PHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nCurrent dependency on total parenteral nutrition (TPN) or IV fluid hydration
PHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nPregnant and breastfeeding women are excluded from this study
PHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nHIV-positive patients on anti-retroviral therapy are ineligible; however, patients with long-standing (> 5 years) HIV on antiretroviral therapy > 1 month (undetectable HIV viral load and CD4 count > 150 cells/uL) may be eligible if the PI determines no anticipated clinically significant drug-drug interactions
PHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nHBV- or HCV-positive patients are ineligible
PHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nKnown history of previous clinical diagnosis of tuberculosis
PHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nNo baseline features suggestive of myelodysplastic syndrome or acute myelogenous leukemia on peripheral blood smear or bone marrow biopsy, if clinically indicated
PHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nNo prior or current evidence of coagulopathy or bleeding diathesis; therapeutic anti-coagulation for prior thromboembolic events is permitted
PHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nConcurrent enrollment in another clinical study, unless it is an observational non-interventional clinical study or the follow-up of an interventional study; any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment; concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable; NOTE: Local treatment of isolated lesions for palliative intent is acceptable (e.g., by local surgery or radiotherapy)
PHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nAll patients must have at least one lesion deemed safe to biopsy and be willing to undergo a mandatory baseline biopsy
PHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nPatients must have undergone bilateral surgical castration or must agree to continue on gonadotropin releasing hormone (GnRH) agonists/antagonists for the duration of the study
PHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nECOG performance status =< 2
PHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nAbsolute neutrophil count >= 1,500/mcL
PHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nWhite blood cell (WBC) >= 3,000/mcL
PHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nPlatelets >= 100,000/mcL
PHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nHemoglobin (Hgb) >= 9 g/dL in the absence of packed red blood cell transfusion 28 days prior to dosing
PHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nAST(SGOT)/ALT(SGPT) =< 2.5 X institutional upper limit of normal (ULN); for subjects with liver metastases, AST or ALT =< 5 × ULN
PHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nTotal bilirubin =< 1.5 X ULN; for subjects with documented or suspected Gilbert’s disease, bilirubin =< 3 X ULN
PHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nCreatinine =< 1.5 X within normal institutional limits OR measured creatinine clearance >= 50 mL/min/1.73 m^2
PHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nPatient must be capable of understanding and complying with protocol requirements and is willing to give informed consent
PHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nPatients who have had prior treatment with olaparib or other PARP inhibitors
PHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nPatients who have had prior immune checkpoint inhibitors, such as MEDI4736 or other PD1 or PD-L1 inhibitors or an anti-CTLA4 therapy
PHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nThe patient has received chemotherapy, radiotherapy, biologic agents or enzalutamide within 3 weeks before the first dose of study treatment (nitrosoureas or mitomycin within 6 weeks); however, for patients receiving abiraterone, they must discontinue the medication at least 14 days before the first dose of study treatment
PHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nThe patient has received any other type of investigational agent within 28 days before the first dose of study treatment
PHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nThe patient has received radionuclide treatment within 6 weeks prior to the first dose of the study treatment
PHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nThe patient is unable to swallow tablets or capsules
PHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nHistory of allergic reactions (known history of anaphylaxis, angioedema, laryngeal edema, serum sickness, or uncontrolled asthma) attributed to compounds of similar chemical or biologic composition to MEDI4736, olaparib, or to other humanized monoclonal antibodies
PHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nHistory of auto-immune disease requiring steroid maintenance, or history of primary immunodeficiency
PHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nReceipt of live attenuated vaccination within 30 days before the first dose of MEDI4736
PHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nThe patient has not recovered to baseline or CTCAE =< grade 1 from toxicity due to all prior therapies, including surgery, except alopecia and other non-clinically significant adverse events (AEs)
PHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nHBV-or HCV-positive patients are ineligible
PHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nAny prior grade >= 3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE > grade 1
PHASE II COLORECTAL CANCER COHORT 6 (MEDI+C ONLY):\r\nReceipt of live attenuated vaccination within 30 days before the first dose of MEDI4736
ELIGIBILITY CRITERIA- ENROLLMENT AND HARVEST
ELIGIBILITY CRITERIA- HARVEST
ELIGIBILITY CRITERIA- LYMPHODEPLETION/INFUSION OF tvs-CTL: Autologous transduced peripheral blood T-cells with >= 15% expression of 14g2a.zeta
ELIGIBILITY CRITERIA- LYMPHODEPLETION/INFUSION OF tvs-CTL: ECOG performance score of 2 or less
ELIGIBILITY CRITERIA- LYMPHODEPLETION/INFUSION OF tvs-CTL: Absolute neutrophil count > 500 mcL
ELIGIBILITY CRITERIA- LYMPHODEPLETION/INFUSION OF tvs-CTL: Platelet > 20,000 mcL
ELIGIBILITY CRITERIA- LYMPHODEPLETION/INFUSION OF tvs-CTL: Serum AST < 5 x institutional upper limit of normal (IULN)
ELIGIBILITY CRITERIA- LYMPHODEPLETION/INFUSION OF tvs-CTL: Total bilirubin < 3 x IULN
ELIGIBILITY CRITERIA- LYMPHODEPLETION/INFUSION OF tvs-CTL: Serum creatinine < 2 x IULN
ELIGIBILITY CRITERIA- LYMPHODEPLETION/INFUSION OF tvs-CTL: Must not be currently receiving any investigational drugs
ELIGIBILITY CRITERIA- LYMPHODEPLETION/INFUSION OF tvs-CTL: Must not have a tumor potentially causing airway obstruction
ELIGIBILITY CRITERIA- LYMPHODEPLETION/INFUSION OF tvs-CTL: Must not be currently receiving immunosuppressive drugs such as corticosteroids (excluding topical treatment), tacrolimus or cyclosporine
ELIGIBILITY CRITERIA- LYMPHODEPLETION/INFUSION OF tvs-CTL: Must not have received a tumor vaccine within previous six weeks
ELIGIBILITY CRITERIA- LYMPHODEPLETION/INFUSION OF tvs-CTL: Must not have a known hypersensitivity to rat monoclonal antibodies
ELIGIBILITY CRITERIA- LYMPHODEPLETION/INFUSION OF tvs-CTL: Must not have had a coma or long or multiple seizures within 7 days after a dose of DTP or Tdap unless a cause other than the vaccine was indicated
ELIGIBILITY CRITERIA- LYMPHODEPLETION/INFUSION OF tvs-CTL: Must not have evidence of previous or current infection with hepatitis B virus
Outside breast imaging will be reviewed at Duke to confirm that findings are consistent with trial eligibility
Outside breast imaging will be reviewed at Duke to confirm findings are consistent with trial eligibility
Blood transfusion within 5 days of the blood draw being used to confirm eligibility
Any number of prior therapies as long as patients have adequate performance status and meet all other eligibility criteria
DONOR ELIGIBILITY CRITERIA:
COHORT A SPECIFIC ELIGIBILITY CRITERIA:
COHORT B SPECIFIC ELIGIBILITY CRITERIA:
ELIGIBILITY CRITERIA FOR T-CELL PRODUCT INFUSION: Absolute lymphocyte count < 500/ul or patient has received lymphodepleting chemotherapy administered at least 24 hours prior to T cell infusion
ELIGIBILITY CRITERIA FOR T-CELL PRODUCT INFUSION: Normal serum sodium levels without need for supplementation
ELIGIBILITY CRITERIA FOR T-CELL PRODUCT INFUSION: ALT (SGPT): =< 5 x ULN
ELIGIBILITY CRITERIA FOR T-CELL PRODUCT INFUSION: Patients must NOT have an active severe infection defined as:\r\n* A positive blood culture within 48 hours of scheduled T cell infusion\r\n* A fever above 38.2 C AND clinical signs of infection within 48 hours of T cell infusion
ELIGIBILITY TO PROCEED WITH PERIPHERAL BLOOD MONONUCLEAR CELL (PBMC) COLLECTION
ELIGIBILITY TO PROCEED WITH RICKHAM PLACEMENT
ELIGIBILITY FOR ENROLLMENT AND TO PROCEED WITH CAR T CELL INFUSION
ELIGIBILITY TO PROCEED WITH PERIPHERAL BLOOD MONONUCLEAR CELL (PBMC) COLLECTION
ELIGIBILITY TO UNDERGO LYMPHODEPLETION:
(ELIGIBILITY CRITERIA AT TIME OF INFUSION OF GENETICALLY MODIFIED AUTOLOGOUS T CELLS): Not requiring pressor support, not having symptomatic cardiac arrhythmias
(ELIGIBILITY CRITERIA AT TIME OF INFUSION OF GENETICALLY MODIFIED AUTOLOGOUS T CELLS): Preservation of renal function, serum creatinine did NOT increase by more than 2 fold above the normal range
(ELIGIBILITY CRITERIA AT TIME OF INFUSION OF GENETICALLY MODIFIED AUTOLOGOUS T CELLS): Total bilirubin =< 2.0 mg/dL
(ELIGIBILITY CRITERIA AT TIME OF INFUSION OF GENETICALLY MODIFIED AUTOLOGOUS T CELLS): No clinical evidence of uncontrolled active infectious process
ELIGIBILITY TO PROCEED WITH PBMC COLLECTION
ELIGIBILITY CRITERIA AT TIME OF INFUSION OF GENETICALLY MODIFIED T CELLS:\r\n* Please note that none of these criteria are applicable of the research participant's donor is undergoing leukapheresis
ELIGIBILITY CRITERIA TO UNDERGO OPTIONAL T CELL ABLATION:\r\n* Please note that none of these criteria are applicable of the research participant's donor is undergoing leukapheresis
All subjects meeting eligibility criteria irrespective of gender, minority or other underrepresented status will be eligible for enrollment into the study
The protocol chairman will determine the eligibility of patients related to hepatic abnormalities
If total bilirubin is =< 2, fractionation is not required for eligibility determination
Group C: Cohort C1A: Subjects age ? 18 years with relapsed/refractory AML by WHO criteria; Cohort C2: Subjects age ? 18 years with relapsed/refractory AML with MLL; Cohort C3: Subjects with previously untreated AML by WHO criteria and who would have met disease eligibility criteria for Group A or B but refuse or are unable to receive chemotherapy and hypomethylating agent as determined by the treating physician
Eligibility criteria cannot be waived
ELIGIBILITY CRITERIA FOR PRE-REGISTRATION
ELIGIBILITY CRITERIA FOR REGISTRATION: Leukocytes >= 3,000/mcL (within one week of registration if patient postop, otherwise within two weeks of registration)
ELIGIBILITY CRITERIA FOR REGISTRATION: absolute neutrophil count >= 1,500/mcL (within one week of registration if patient postop, otherwise within two weeks of registration)
ELIGIBILITY CRITERIA FOR REGISTRATION: platelets >= 100,000/mcL (within one week of registration if patient postop, otherwise within two weeks of registration)
ELIGIBILITY CRITERIA FOR REGISTRATION: AST(SGOT)/ALT(SGPT) =< 2.0 x institutional upper limit of normal (within one week of registration if patient postop, otherwise within two weeks of registration)
PART II: All eligibility requirements and exclusion criteria as described in PART 1 must be fulfilled within 14 days of receiving subsequent doses; testing completed from Part 1 may be accepted as long as completed within this time frame (+/- 1 day)
PROCUREMENT ELIGIBILITY:
PROCUREMENT ELIGIBILITY:
TREATMENT ELIGIBILITY:
TREATMENT ELIGIBILITY:
Patients may be on other trials (either here at M.D. Anderson Cancer Center or at an outside institution) as long as the other eligibility criteria are met
Patients older than 21 will be considered for eligibility at the discretion of the principal investigator (PI)
Any patient not meeting the eligibility criteria
Additional Eligibility Prior to Transplant Two:
Positive 68Ga-PSMA-R2 PET/CT scan for central eligibility assessment. Patients who receive 68Ga-PSMA-R2 as part of separate clinical protocol are eligible (must meet all study eligibility criteria)
Subjects with a history of autologous stem cell transplant are eligible for study participation provided the following eligibility criteria are met: transplant was >100 days prior to study enrolment; no active infection(s); subjects meets the remainder of the eligibility criteria outlined in this protocol.
Subjects with a history of autologous SCT, are eligible for study participation provided the following eligibility criteria are met: Autologous SCT was >100 days prior to study enrollment; No active bacterial, viral, or fungal infection(s) present; Subject meets the remainder of the eligibility criteria.
Patient must have hematologic malignancy that meets institutional eligibility requirements for cord blood transplant
ADDITIONAL INDUCTION ELIGIBILITY CRITERIA:
PHASE 1 SPECIFIC ELIGIBILITY CRITERIA
PHASE 2 SPECIFIC ELIGIBILITY CRITERIA
GENERAL ELIGIBILITY CRITERIA
Patients with liver metastases who do not meet the eligibility parameters may only be enrolled at the discretion of the principal investigator (PI)
STUDY ELIGIBILITY CRITERIA FOR OVERALL STUDY PARTICIPATION (INITIAL REGISTRATION FOR COHORT 1; ONLY REGISTRATION FOR COHORTS 1A & 1B):
ELIGIBILITY CRITERIA TO INITIATE TREATMENT (FOR SECONDARY REGISTRATION - COHORT 1 PARTICIPANTS ONLY):
ELIGIBILITY CRITERIA: TREATMENT PROTOCOL
ELIGIBILITY CRITERIA PRIOR TO FIRST VACCINATION
Patients must meet all SCREENING/PRE-SCREENING and SUB-STUDY REGISTRATION COMMON ELIGIBILITY CRITERIA as specified in S1400: Phase II/III Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer (Lung-Map)
SECONDARY ELIGIBILITY CRITERIA FOR GENE-MODIFIED HSPC INFUSION
Patients must meet all SCREENING/PRE-SCREENING and SUB-STUDY REGISTRATION COMMON ELIGIBILITY CRITERIA as specified in S1400: Phase II/III Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer (Lung-Map)
Patients must meet all SCREENING/PRE-SCREENING and SUB-STUDY REGISTRATION COMMON ELIGIBILITY CRITERIA as specified in S1400: Phase II/III Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer (Lung-Map)
Patients who are currently receiving other anti-cancer agents with the exception of those delineated in the eligibility criteria
ELIGIBILITY CRITERIA FOR HSPC TRANSPLANTATION
ELIGIBILITY TO RECEIVE T CELL INFUSION:
ELIGIBILITY CRITERIA FOR SECOND CELL INFUSION:
Subjects must meet all the initial eligibility criteria except for the requirement regarding previous anti-GD2-CAR therapy
Patients with significant hepatic dysfunction (not meeting liver function tests [LFT] eligibility criteria)
OTHER ELIGIBILITY CRITERIA (APPLIES TO BOTH COHORT A AND COHORT B UNLESS SPECIFIED)
Patients must meet all SCREENING/PRE-SCREENING and SUB-STUDY REGISTRATION COMMON ELIGIBILITY CRITERIA as specified in S1400: Phase II/III Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer (Lung-Map)
Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness Eligibility criteria for this study have been carefully considered to ensure the safety of the study subjects and that the results of the study can be used. It is imperative that subjects fully meet all eligibility criteria
Eligibility for pre-selected salvage chemotherapy, according to the Investigator's assessment.
Patients must meet all SCREENING/PRE-SCREENING and SUB-STUDY REGISTRATION COMMON ELIGIBILITY CRITERIA as specified in S1400: Phase II/III Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer (Lung-Map)
Have had chemotherapy or investigational therapy, with the exception of hydroxyurea, within 4 weeks of study entry; previous treatment at any time with either ruxolitinib or decitabine as single agents will not exclude eligibility; previous stem cell transplant will also not exclude eligibility as long as other inclusion/exclusion criteria have been met
Once all other eligibility criteria are confirmed, must have an apheresis product of non-mobilized cells received and accepted by the manufacturing site. Note: Apheresis product will not be shipped to or assessed for acceptance by the manufacturing site until documented confirmation of all other eligibility criteria is received.
Patients with multifocal or multicentric disease are eligible as long as at least one area meets eligibility criteria
PROSPECTIVE SCREENING ELIGIBILITY CRITERIA:
Note: supportive care (e.g. transfusion of red blood cells) is allowed to meet eligibility criteria
PRE-REGISTRATION (PRE-SURGERY) ELIGIBILITY CRITERIA
REGISTRATION (POST-SURGERY) ELIGIBILITY CRITERIA
Pre-registration eligibility criteria continue to be met
Patients must meet all SCREENING/PRE-SCREENING and SUB-STUDY REGISTRATION COMMON ELIGIBILITY CRITERIA as specified in S1400: Phase II/III Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer (Lung-Map)
Secondary or hypoplastic MDS or other subtype with eligibility for treatment with immunotherapy
PRE-REGISTRATION ELIGIBILITY CRITERIA
REGISTRATION ELIGIBILITY CRITERIA
Patient meets the eligibility criteria outlined above
Eligibility for autologous SCT (participants with r/r DLBCL)
INDUCTION ELIGIBILITY:
CONSOLIDATION ELIGIBILITY:
Patients are eligible >= 6 weeks after therapeutic 131I-MIBG provided that all other eligibility criteria are met
Any individual that does not meet the eligibility criteria for transplantation or donor eligibility will not be a part of this trial
Eligibility to a higher priority trial for first line or recurrent endometrial cancer (unless patient is unwilling to participate in such a trial)
Platelets >= 75 K/uL (platelet transfusions to help patients meet eligibility criteria are not allowed within 3 days before study enrollment)
Patients who meet eligibility for the protocol but are not candidates to receive further chemotherapy may be treated on Arm C
Note: Transfusions/infusions to meet eligibility criteria are not allowed but if in the opinion of the Principal Investigator, it is beneficial, the patient may be rescreened after receiving one of these procedures.
Patients should undergo a repeat MRI prior to enrollment if there is a significant worsening or new neurologic symptoms in the interval between the eligibility scan and start of protocol therapy\r\n* The repeat scan will act as a new baseline and the eligibility scan for these patients
ELIGIBILITY FOR ENROLLMENT/SCREENING (ARMS 1 AND 2): Histopathological documentation of NSCLC or mesothelioma
ELIGIBILITY FOR TREATMENT ON ARM 2: Patients must express HLA-A*0201
Persistence of clinically relevant therapy related toxicity from previous chemotherapy and/or radiotherapy; this does not include hemoglobin or other hematologic or laboratory criteria, as long as eligibility criteria are met as outlined above
For subject eligibility and withdrawal, QT correction formula QTcB will be used.
Patients may have had enucleation of one eye, as long as the remaining eye meets the eligibility criteria
ELIGIBILITY CRITERIA AT TIME OF INFUSION OF GENETICALLY MODIFIED AUTOLOGOUS T CELLS:
Exceptions to eligibility will not be granted for this study
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
Platelets >= 50,000/mcL in the absence of transfusion support within 7 days prior to determination of eligibility
Administration of growth factors or blood transfusions will not be allowed within 4 weeks of the hematology labs required to confirm eligibility
PRE-REGISTRATION ELIGIBILITY CRITERIA
REGISTRATION ELIGIBILITY CRITERIA
PHASE I PORTION ELIGIBILITY CRITERIA
PHASE II PORTION ELIGIBILITY CRITERIA
Bilateral breast cancers that individually meet eligibility criteria are allowed
The patient must - at the time of re-induction - satisfy all the eligibility criteria
ELIGIBILITY TO RECEIVE DLI POST-TRANSPLANT:
Blood transfusion within 5 days of the blood draw being used to confirm eligibility
Willing to undergo biopsy for research purposes only; Note: if possible, the pre-treatment biopsy should be performed after all other eligibility criteria are confirmed
No concomitant anti-cancer chemotherapy or other systemic drugs; palliative radiation therapy will be allowed as long as the patient meets all other eligibility criteria
ELIGIBILITY TO PROCEED TO OVA:
FURTHER ELIGIBILITY DETAILS FOR PATIENTS WITH PROGRESSIVE DISEASE (COHORTS 1 AND 3A/3B):
FURTHER ELIGIBILITY DETAILS FOR PATIENTS WITH OPERABLE DISEASE (COHORT 2):
REGISTRATION ELIGIBILITY
Blood or albumin transfusion within 5 days of the blood draw being used to confirm eligibility
ELIGIBILITY PRIOR TO CELL COLLECTIONS FOR DENDRITIC CELL GENERATION:
ELIGIBILITY PRIOR TO POST-CHEMOTHERAPY IMMUNOTHERAPY:
RANDOMIZATION ELIGIBILITY CRITERIA
In the event of significant BM involvement, the above hematologic criteria will not be required for enrollment eligibility
The patient currently does not meet the protocol’s eligibility/enrollment criteria for any reason
There is a high likelihood that the patient, in the opinion of the principal investigator (PI) will meet the protocol’s eligibility/enrollment criteria to proceed to transplant after standard therapy is completed
Specific eligibility criteria stratum 4:\r\n* Disease status: \r\n** Age between 6 and 18 months of age\r\n** Patients must have a symptomatic and/or life threatening plexiform neurofibroma(s)
Platelet or red cell transfusions to help patients meet eligibility criteria are not allowed within 3 days before study enrollment
Meets local transplant center eligibility requirements for HCT
Patient must meet eligibility criteria for allogeneic transplantation
ELIGIBILITY CRITERIA FOR HISTORICAL CONTROL POPULATION
Imaging evaluations necessary to establish eligibility for study entry must be done within three (3) weeks prior to registration; all other evaluations necessary to establish eligibility for study entry must be done within two (2) weeks prior to registration; in the event that the patient’s condition deteriorates (performance score < 60) within 48 hours prior to the injection the patient is no longer eligible to receive HSV1716 injection
Patients with multicentric or bilateral disease are eligible if the target lesions meet the other eligibility criteria; samples from all available tumors are requested for research purposes
ELIGIBILITY FOR BLAST COLLECTION (PROCUREMENT)
ELIGIBILITY FOR VACCINE AND LENALIDOMIDE ADMINISTRATION (PROTOCOL ENTRY)
INCLUSION CRITERIA - HPC-A CELL DONOR: Meets donation eligibility requirements as outlined by 21 Code of Federal Regulations (CFR) 1271
Platelet transfusions to help patients meet eligibility criteria are not allowed within 3 days prior to screening complete blood count (CBC) or cycle 1, day 1 treatment
DONOR: Regarding donation eligibility, is identified as either:\r\n* Completed the process of donor eligibility determination as outlined in 21 case report form (CFR) 1271 and agency guidance; OR\r\n* Does not meet 21 CFR 1271 eligibility requirements, but has a declaration of urgent medical need completed by the principal investigator or physician sub-investigator per 21 CFR 1271
Regarding eligibility, is identified as either:\r\n* Completed the process of donor eligibility determination as outlined in 21 CFR 1271 and agency guidance; OR\r\n* Does not meet 21 CFR 1271 eligibility requirements, but has a declaration of urgent medical need completed by the principal investigator or physician sub-investigator per 21 CFR 127
Histologically confirmed, Stage IB-IVB, invasive cervical carcinoma associated with HPV 16 and/or 18 and meeting the following eligibility criteria for either Cohort 1 or Cohort 2;
immediately previous cancer chemotherapy, radiotherapy, or immunotherapy; and eligibility for allogeneic HSCT at the time of enrollment.
ELIGIBILITY CRITERIA FOR CROSSOVER REGISTRATION
Meet all eligibility criteria with the exception of:\r\n* Prior therapy with trametinib will be permitted\r\n* All laboratory parameters must be met as outlined except for ALT and total bilirubin, which must meet criteria for continued therapy\r\n* Patients who are eligible for cross-over will not need to undergo another ophthalmologic examination
Blood or albumin transfusion within 5 days prior to the blood draw being used to confirm eligibility
PRIMARY ELIGIBILITY (PRE-OPERATIVE [OP])
SECONDARY ELIGIBILITY
Patients who have received an autologous hematopoietic stem cell infusion to support non-myeloablative therapy (such as 131I-MIBG) are eligible at any time as long as they meet the other criteria for eligibility.
Eligibility for autologous SCT
General Eligibility Criteria (All Parts)
Specific Eligibility Criteria, Part A
Subjects must meet general eligibility criteria.
Specific Eligibility Criteria, Part B
Subjects must meet general eligibility criteria. The specific eligibility criteria listed here will apply to subjects enrolling to different cohorts of Part B.
Specific Eligibility Criteria, Part C - Subjects must meet general eligibility criteria.
Specific Eligibility Criteria, Part D - Subjects must meet general eligibility criteria
Patients may not have clinically symptomatic hypothyroidism; testing is not required for eligibility
Blood transfusion within 5 days prior to blood draw being used to confirm eligibility
ELIGIBILITY PRIOR TO INITIATING CT-011:
ELIGIBILITY FOR 2.4 MG/KG DOSING IN THE NEW COHORT
No concomitant anti-cancer chemotherapy or other systemic drugs; palliative radiation therapy will be allowed as long as the patient meets all other eligibility criteria
All patients or their legal guardians (if the patient is < 18 years old) must sign a document of informed consent (screening protocol) prior to performing studies to determine patient eligibility; after confirmation of patient eligibility all patients or their legal guardians must sign the protocol specific informed consent to document their understanding of the investigational nature and the risks of this study before any protocol related studies are performed (other than the studies which were performed to determine patient eligibility) (Cohort 1)
Administration of growth factors or blood transfusions will not be allowed to confirm eligibility
Patients who had prior lung resection are eligible provided they fulfill the rest of the eligibility criteria
Eligibility for treatment with SRS confirmed by a radiation oncologist
PRE-REGISTRATION ELIGIBILITY CRITERIA:
Patients at institutions that elect to confirm eligibility locally may be pre-registered at the same time as they are randomized
REGISTRATION/RANDOMIZATION ELIGIBILITY CRITERIA
Centers that standardly use positron emission tomography (PET) or magnetic resonance spectroscopy (MRS) to determine a diagnosis of radionecrosis are permitted to use these modalities to assist in their patient selection; however the criteria described for conventional MR and/or DSC should also be met for study eligibility; both PET and MRS are not mandatory for study eligibility
Central imaging real-time review (72 hour turn around) to confirm eligibility (for institutions that opt to utilize central imaging review to confirm eligibility)
Patient eligibility criteria for entry into the project include:
FCG eligibility criteria include:
Patients on ongoing chemotherapy regimen at the time of eligibility:
PATIENT ELIGIBILITY CRITERIA
CAREGIVER ELIGIBILITY CRITERIA
FCG has been invited to participate in the trial with a patient who meets eligibility criteria
PHASE 1: PATIENT ELIGIBILITY: At least 1.5 years from treatment (which is a typical time for preparation to transfer to long-term follow-up care)
PHASE 1: PARENT ELIGIBILITY: Caregiver of a pediatric cancer survivor age 18-25 who was primary caregiver at diagnosis
PHASE 1: PARENT ELIGIBILITY: Patient is at least 1.5 years from treatment
PHASE 1: PROVIDER ELIGIBILITY: Health professional who works with childhood cancer survivors ages 18 to 25
PHASE 2: PEER MENTOR ELIGIBILITY: Age 21-29
PHASE 2: PEER MENTOR ELIGIBILITY: At least 1.5 years from treatment
PHASE 2: PATIENT ELIGIBILITY: Age 18-25
PHASE 2: PATIENT ELIGIBILITY: At least 1.5 years from treatment
PHASE 3A: AYA SURVIVOR ELIGIBILITY: Age 18-29
PHASE 3A: AYA SURVIVOR ELIGIBILITY: At least 2 years from treatment for any pediatric cancer diagnosed at age 0-19
PHASE 3B: PEER MENTOR ELIGIBILITY: Age 21-29
PHASE 3B: PEER MENTOR ELIGIBILITY: At least 2 years from treatment
PHASE 3B: PATIENT ELIGIBILITY: Age 18-25
PHASE 3B: PATIENT ELIGIBILITY: At least 2 years from treatment for any pediatric cancer diagnosed at age 0-19
ELIGIBILITY CRITERIA FOR BOTH SURVIVORS AND CO-SURVIVORS:
NON-RANDOMIZED OBSERVATIONAL COMPONENT ELIGIBILITY:\r\nUndergoing or initiating active surveillance
NON-RANDOMIZED OBSERVATIONAL COMPONENT ELIGIBILITY:\r\nEnglish-speaking
Patients must meet eligibility criteria for induction of myelosuppressive chemotherapy as defined by clinical standards
Eligibility criteria same as stage I
The patient is enrolled on a COG trial that uses criteria for unrelated donor HSCT, which conflict with our eligibility criteria
PATIENTS ELIGIBILITY CRITERIA
Is currently in a partnered relationship that could involve sexual activity (as determined by eligibility screening script)
FOCUS GROUP (PHASE 1) ELIGIBILITY CRITERIA:
USER/USABILITY TESTING (PHASE 2) ELIGIBILITY CRITERIA:
RANDOMIZED CONTROL TRIAL (RCT) (PHASE 3) ELIGIBILITY CRITERIA:
PATIENTS ELIGIBILITY CRITERIA:
CAREGIVERS ELIGIBILITY CRITERIA:
Subjects with bilateral disease are eligible if they meet other eligibility criteria
PATIENT PARTICIPANT ELIGIBILITY CRITERIA (PHASE 1 & 2)
CLINICIAN PARTICIPANT ELIGIBILITY CRITERIA
STAKEHOLDER PARTICIPANT ELIGIBILITY CRITERIA
Family caregiver identified by a lung cancer patient who meets the eligibility criteria listed above
PATIENT ELIGIBILITY REQUIREMENTS:
FAMILY CAREGIVER ELIGIBILITY REQUIREMENTS:
ONCOLOGIST ELIGIBILITY REQUIREMENTS:
Patients may undergo electrolyte repletion therapy to meet eligibility requirements
Eligibility will not be restricted by race or sex
Participants must have already met one or more eligibility criteria and have a reasonable expectation of meeting any remaining eligibility criteria for the therapeutic clinical trial
PATIENT PRE-REGISTRATION ELIGIBILITY CRITERIA:
PATIENT REGISTRATION ELIGIBILITY CRITERIA:
ANNUAL SCREENING REGIMEN ELIGIBILITY CHECK
SITE ELIGIBILITY (AS PER SC SELF-REPORT)
SITE COORDINATOR (SC) ELIGIBILITY (AS PER SELF-REPORT)
PATIENT ELIGIBILITY (AS PER SELF-REPORT)
ELIGIBILITY FOR THE OPTIONAL SUB-STUDY
ELIGIBILITY FOR THE 2-YEAR EXTENSION
ELIGIBILITY FOR THE 2-YEAR EXTENSION: Patient is currently taking finasteride or dutasteride
GENERAL ELIGIBILITY (ALL PATIENTS):
ELIGIBILITY FOR MYELOABLATIVE CONDITIONING
ELIGIBILITY FOR REDUCED INTENSITY CONDITIONING:
Eligibility criteria will include: Postmenopausal women with of first incidence of early stage (stages 0 - III) hormone receptor positive breast cancer stabilized on anastrozole therapy for at least 3 months
Completed all eligibility questions
Subjects with a history of autologous stem cell transplant are eligible for study participation provided the following eligibility criteria are met: transplant was > 100 days prior to study enrolment, no active infection; subject meets the remainder of the eligibility criteria outlined in the study protocol.
ELIGIBILITY CRITERIA FOR NORMAL-WEIGHT WOMEN IN PILOT STUDY
Patients with a locoregional tumor recurrence following surgery will be eligible provided they meet other eligibility criteria
Patients must meet eligibility criteria for 131I-MIBG therapy
A pregnancy test will be used to determine eligibility in appropriate patients
For patients enrolled on the fluorouracil, leucovorin calcium, irinotecan hydrochloride, and oxaliplatin (FOLFIRINOX) trial (HRPO# 201201124), their eligibility would include eligibility from that trial as well as the inclusion criteria outlined above
Meets the criteria below for the appropriate cohort:
Required patient clinical data is not available for evaluation of eligibility criteria
PRIMARY ELIGIBILITY (PRE-OPERATIVE [OP])
SECONDARY ELIGIBILITY
STUDY SITE ELIGIBILITY:
PART A ELIGIBILITY CRITERIA
PART B ELIGIBILITY CRITERIA
No limitations on prior therapy for eligibility; eligible patients must be receiving their first allogeneic BMT
Will include all prospective trial participants in this study that come from Twitter in response of our SM recruitment interventions, provided they meet the specific trial's eligibility criteria
Persons who do not meet the eligibility criteria of any of the trials open to accrual will be excluded from participation, and persons who may be eligible (e.g., disease/histology, stage, prior treatment) but do not meet additional trial-specific requirements such as insurance or allergy to drug)
PRE-REGISTRATION ELIGIBILITY CRITERIA
REGISTRATION ELIGIBILITY CRITERIA