Patients treated with prior surgery are eligible for this study if they otherwise meet eligibility criteria
Patients with INRG stage L2 tumors without amplification of MYCN regardless of tumor histology (may meet criteria for may meet criteria for high risk classification but are not eligible for this trial)
Note: Patients diagnosed with anaplastic large cell lymphoma (ALCL) harboring a gene rearrangement of interest may be eligible provided they meet all other inclusion/exclusion criteria
Patients crossing over from monotherapy to combination therapy do not have to be fully rescreened; however, they do need to meet performance status, organ function, and blood parameters and not meet any of the exclusion criteria
Please note: patients who do not meet the above criteria because of Gilbert’s syndrome are still eligible
Patients must meet the following laboratory criteria:
Patients screened for this trial should be expected to meet the criteria for treatment
Subjects with treated brain metastases are eligible provided they meet the following criteria:
Grade I meningiomas will be allowed as long as they meet criteria for progression
To be eligible for participation in the study, patients must meet all of the following inclusion criteria:
Patients with brain metastases unless they meet the criteria
Patients must meet ONE of the criteria outlined in either a, b, c OR d:
Participant must meet the following criteria as indicated on the clinical laboratory tests:
Each patient must meet the following criteria:
Patients must not meet any of the following criteria:
Patients who do not meet inclusion 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
DONOR: Failure to meet institutional criteria for stem cell donation
Patient has a WHO performance status 0-2. Patients in Arm 1 to 4 must also meet the following inclusion criteria:
Meet standard criteria for RIT:\r\n* < 25% marrow involvement with FL\r\n* No evidence of myelodysplasia
Must meet the following clinical laboratory criteria at study entry:
Patients who have had brain metastases unless they meet the criteria.
Note: Hematology and other lab parameters that are =< grade 2 but still meet criteria for study entry are allowed. Furthermore, changes in laboratory parameters during the study should not be considered adverse events unless they meet criteria for dose modification(s) of study medication outlined by the protocol and/or worsen from baseline during therapy.
Failure to meet any of the criteria set forth in the inclusion criteria section
Meet the following disease activity criteria:
All patients must meet the following inclusion and exclusion criteria; NO EXCEPTIONS WILL BE GIVEN
Patients must be able to meet the criteria without transfusion or receipt of colony stimulating factors within 4 weeks before obtaining sample
Subjects who fail to meet the above criteria
Patients must meet eligibility in at least 1 of the following 6 groups:
LYMPHODEPLETION: Subjects must have autologous transduced activated T-cells that meet the certificate of analysis (CofA) acceptance criteria
Subjects must meet all of the following criteria to be included in this study:
Subjects who meet any of the following criteria will be excluded from this study:
Each patient must be positive for HLA-A*02 and meet all of the following inclusion criteria to be enrolled in the study
Patients must have baseline evaluations performed prior to the first dose of study drug and must meet all inclusion and exclusion criteria
Must meet one or more of the consensus criteria for initiating treatment MM Participants:
Lysate must meet release criteria
Subject for whom tumor lysate does not meet release criteria
Patients are required to meet the following criteria to proceed to AHSCT:
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).
Osteosarcoma participants receiving combination therapy of lenvatinib with ifosfamide and etoposide should meet all the exclusion criteria, with the exception of Criterion Number 6.
Patients are required to meet criteria for initiation of therapy for their B-NHL according to published guidelines by the National Comprehensive Cancer Network (NCCN)
Meet criteria for a current major depressive episode or suicidality
Patients must meet the following clinical criteria to receive CMVpp65-CTL infusions
Patient does not meet the requirements for prior ipilimumab treatment listed in inclusion above
Patients who have had prior treatment with 131I-MIBG who do not meet the re-treatment 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:
Patients must have relapsed or refractory disease after at least one prior therapy and not have traditional options available or decline these. All patients must meet all of the following inclusion criteria to be enrolled on the study:
Central nervous system (CNS) metastases which do not meet the criteria outlined in the inclusion criteria
Note: patients enrolled after chemotherapy do not have to meet the above criteria
Must meet the following laboratory criteria:
Failure to meet inclusion criteria;
Females who are of childbearing potential must practice effective contraception and meet the following criteria:
Must meet following requirements:
patients with CRPC must meet PCWG3 criteria for disease progression at trial entry
Female patients are eligible for the study if they meet the following criteria:
Note: Hematology and other lab parameters that are ? grade 2 BUT still meet criteria for study entry are allowed; furthermore, changes in laboratory parameters during the study should not be considered adverse events unless they meet criteria for dose modification(s) of study medication outlined by the protocol and/or worsen from baseline during therapy
Subjects must have adequate renal, hepatic and bone marrow function based on screening laboratory assessments. Baseline hematologic studies and chemistry and coagulation profiles must meet the following criteria:
DONOR: Failure to meet institutional criteria for donation as described in the Standard Practice Guidelines
Patients with prior progressive disease who do not meet criteria above, are eligible as long as they have not been off treatment for > 3 months prior to enrollment on NANT 2011-04
Subjects must meet certain laboratory criteria
Central nervous system (CNS) metastases which do not meet the criteria outlined in inclusion criteria
Biopsy does not meet inclusion criteria
PHASE II: For participation in the imaging research studies, patients must meet the additional following 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:
Patients should not meet criteria for post PV or post ET-myelofibrosis (MF)
Patients should not meet criteria for post PV or post ET-myelofibrosis (MF)
Subject must meet the following criteria as indicated on the clinical laboratory tests:
NSCLC patients must meet criteria for MET and/or Axl expression or,
HNSCC patients must meet criteria for MET and/or Axl expression or,
Patients must meet pre-entry requirements
The patient must meet one of the following (a) or (b) or (c):
The patient must meet one of the following (a) or (b) or (c):
Meet baseline laboratory data criteria
Must meet all inclusion criteria defined in main study and in addition the following criteria must be met:
Part 1 Dose Escalation subjects must meet 1 of the following criteria:
Part 2 Dose Expansion subjects must meet 1 of the following criteria:
Laboratory tests must meet minimum safety requirements
Patients who do not meet parent protocol criteria to continue study treatment.
Patients must meet the following laboratory criteria at screening:
Patients with prior radiation therapy are eligible if they meet the following criteria:
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.
Subjects enrolled on the combination therapy phase must not meet the above exclusion criteria and must be eligible to receive paclitaxel or FOLFIRI per most current prescribing information, or at the discretion of the Investigator.
Successful T cell test expansion (to be performed as part of inclusion criteria until 3 subjects meet all enrollment criteria)
Patients are permitted to washout current drug therapy to meet these entry criteria if they have a known diagnosis of Cushing's disease.
Subject must meet the following criteria as indicated on the clinical laboratory tests:
Patients must meet the following laboratory criteria:
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
Subjects must meet the following criteria:
Must meet the following clinical laboratory criteria at study entry:
Must meet one of the following two criteria:
Baseline hematologic studies and chemistry profiles must meet the following criteria:
Patients must meet all of the following criteria to be enrolled in the study:
Subject must meet the following criteria as indicated on the clinical laboratory tests.
Patients failing to meet the inclusion criteria
Central nervous system (CNS) metastases which do not meet the criteria outlined in inclusion criteria
Failure to meet any of the criteria set forth in inclusion
Lysate must meet release criteria
Subject for whom tumor lysate does not meet release criteria
Patients must meet the following laboratory criteria:
Adequate hematologic function Arm A (except for CLL subjects with significant BM involvement by biopsy) must meet the following criteria:
Platelet count ? 75,000/mm3 Arms B, C, and D must meet the following criteria:
CRITERIA FOR RANDOMIZATION\r\n* Participants must meet the following criteria to qualify for HD-ADE versus Clo/AraC randomization; participants who do not meet these criteria may still be enrolled, but will be treated on HD-ADE arm and will NOT be randomized
LOW RISK MEDULLOBLASTOMA (patients must meet all of the following criteria):
Patients less than 3 years of age at diagnosis must meet one of the two following criteria:
DONOR: Failure to meet FHCRC criteria for stem cell donation
DONOR: Failure to meet institutional criteria for donation as described in the Standard Practice Guidelines
Central nervous system (CNS) metastases which do not meet the criteria outlined in the inclusion criteria
Patients must meet diagnostic criteria for NF2 including presence of bilateral VS (10 patients) or idiopathic VS without evidence of genetic syndrome (10 patients)
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
Subjects in Cohort 2 of Arm C must meet the following criteria:
Participant must meet at least one of the following criteria in the judgment of the investigator or sub-investigator:
Central nervous system (CNS) metastases which do not meet the criteria outlined in inclusion criteria
ALC ? 900/?l (Note: Patients with AML are not required to meet these hematologic criteria).
Cardiac Exclusion Criteria: Patients will be excluded if these meet any of the following:
Prior therapy must meet all of the following criteria:
For leukapheresis, patients must meet the following criteria (any exceptions to this will require prior approval by the apheresis director and principal investigator [PI]):
Patients who do not meet the above inclusion criteria will not receive leukapheresis
Subjects who fail to meet the above criteria
Subject must meet the following criteria as indicated on the clinical laboratory tests*:
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
Specifically, subjects must meet one or more of the following criteria:
Patients must meet one or more of the following indications for treatment:
Patients must have at least ONE of the following (lesions may have received prior radiation therapy as long as they meet the other criteria listed below):
Patients with known bone marrow metastatic disease will be eligible for study as long as they meet hematologic function criteria above.
Patients eligible for HSCT at the time of screening. However, patients who meet one or both of the following criteria may be eligible for study participation:
Meet at least one of the criteria below:
Patients must meet criteria for acute lung injury
Failure to meet any of the criteria set forth in Section 3.1.
Must meet all inclusion and exclusion criteria
Patients previously treated with carfilzomib are eligible as long as they meet the following criteria:
Patients must meet pre-entry requirements
Usability Test interview participants must meet criteria above and may also include patients who have undergone one or more cycles of treatment
Patient’s disease status should meet criteria as outlined by institutional master protocol
Patients on full dose anticoagulants (e.g., warfarin or LMW heparin) must meet both of the following criteria:
If they are not patients of Massey Cancer Center or do not meet the inclusion criteria listed above
Meet all screening requirements
Meet screening criteria
Children who do not meet the above criteria
Meet screening criteria
Meet all inclusion criteria above
Patients are to be excluded from randomization for Aim 2 of this study if they meet any of the following criteria:
Subjects with bilateral disease are eligible if they meet other eligibility criteria
Patients who will be enrolled on the observational arm should meet the 2nd, 3rd, and 4th inclusion criteria only
Patients who will be enrolled on the observational arm should not meet the 3rd and 4th exclusion criteria only
meet diagnostic criteria for chronic insomnia (i.e., lasting for at least one month)
DONOR: Failure to meet Fred Hutchinson Cancer Research Center (FHCRC) or local criteria for stem cell donation
If women have had a hysterectomy and still have their ovaries, they must meet the FSH criteria described above
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
Participants must meet any one of the following 6 criteria:
Laboratory (lab) results do not meet inclusion criteria
Any lab results that do not meet inclusion criteria after the Screen 1 blood tests
IF PROTOCOL 2546 SERVES AS AN ADJUNCT PROTOCOL, THE PATIENTS ONLY NEEDS TO MEET INCLUSION CRITERIA 1 THROUGH 5A
IF PROTOCOL 2546 SERVES AS AN ADJUNCT PROTOCOL, THE PATIENT ONLY NEEDS TO MEET EXCLUSION CRITERIA 1 THROUGH 3
DONOR: Failure to meet local criteria for stem cell donation
Subject presenting with bilateral breast cancer may be enrolled if BOTH cancers meet all of the inclusion and none of the exclusion criteria
Use of antidepressants is permitted if dose has been the same for at least 12 weeks prior to study entry if patient still DOES NOT meet exclusion criteria #3
Patients failing to meet the inclusion criteria
Subjects who do not meet the above mentioned inclusion criteria
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
Does not meet above criteria of suspicious PSA elevation
Biopsy does not meet inclusion criteria
All subjects enrolled into either Part 1 or Part 2 must meet all of the following inclusion criteria to be eligible:
Subject must meet the following criteria as indicated on the clinical laboratory tests:
Does not meet histologic criteria
The participant must meet the following criteria relevant to their specific diagnosis:
Must meet at least 1 of the following 3 criteria for progressive metastatic disease, according to Prostate Cancer Working Group 2 (PCWG2) criteria:
Admission or evidence of illicit drug use, drug abuse, or alcohol abuse. Entry Criteria for Continuation to Optional Part B: After completing Part A of the study, participants may choose to enter the optional Part B of the study. To be eligible for the optional Part B, participants must have completed Part A and be reassessed to determine if they meet the entry criteria for optional Part B. Only participants who meet the following criteria may enter into Part B:
Participants with a history of CNS metastases are eligible provided they are stable and meet the criteria details in the protocol.
Patients eligible for this companion sample collection protocol must not meet any of the exclusion criteria in the CLEE011A2404 study, in addition to the following:
