Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial)
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| ClinicalTrials.gov Identifier: NCT03155620 |
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Recruitment Status :
Recruiting
First Posted : May 16, 2017
Last Update Posted : December 13, 2018
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Sponsor:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
National Cancer Institute (NCI)
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Brief Summary:
This Pediatric MATCH screening and multi-sub-study phase II trial studies how well treatment that is directed by genetic testing works in pediatric patients with solid tumors, non-Hodgkin lymphomas, or histiocytic disorders that have progressed following at least one line of standard systemic therapy and/or for which no standard treatment exists that has been shown to prolong survival. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic changes or abnormalities (mutations) may benefit more from treatment which targets their tumor's particular genetic mutation, and may help doctors plan better treatment for patients with solid tumors or non-Hodgkin lymphomas.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Advanced Malignant Solid Neoplasm Ann Arbor Stage III Childhood Non-Hodgkin Lymphoma Ann Arbor Stage IV Childhood Non-Hodgkin Lymphoma Childhood Langerhans Cell Histiocytosis Histiocytic Sarcoma Juvenile Xanthogranuloma Malignant Glioma Recurrent Central Nervous System Neoplasm Recurrent Childhood Ependymoma Recurrent Childhood Malignant Germ Cell Tumor Recurrent Childhood Medulloblastoma Recurrent Childhood Non-Hodgkin Lymphoma Recurrent Childhood Rhabdomyosarcoma Recurrent Childhood Soft Tissue Sarcoma Recurrent Ewing Sarcoma Recurrent Glioma Recurrent Hepatoblastoma Recurrent Langerhans Cell Histiocytosis Recurrent Malignant Solid Neoplasm Recurrent Neuroblastoma Recurrent Osteosarcoma Recurrent Peripheral Primitive Neuroectodermal Tumor Recurrent Rhabdoid Tumor Refractory Central Nervous System Neoplasm Refractory Childhood Malignant Germ Cell Tumor Refractory Ewing Sarcoma Refractory Glioma Refractory Hepatoblastoma Refractory Langerhans Cell Histiocytosis Refractory Malignant Solid Neoplasm Refractory Medulloblastoma Refractory Neuroblastoma Refractory Non-Hodgkin Lymphoma Refractory Osteosarcoma Refractory Peripheral Primitive Neuroectodermal Tumor Refractory Rhabdoid Tumor Refractory Rhabdomyosarcoma Rhabdoid Tumor Stage III Osteosarcoma AJCC v7 Stage III Soft Tissue Sarcoma AJCC v7 Stage IV Osteosarcoma AJCC v7 Stage IV Soft Tissue Sarcoma AJCC v7 Stage IVA Osteosarcoma AJCC v7 Stage IVB Osteosarcoma AJCC v7 Wilms Tumor | Procedure: Biopsy Procedure: Biospecimen Collection Drug: Ensartinib Drug: Erdafitinib Other: Laboratory Biomarker Analysis Drug: Larotrectinib Procedure: Mutation Carrier Screening Drug: Olaparib Drug: Palbociclib Other: Pharmacological Study Drug: PI3K/mTOR Inhibitor LY3023414 Drug: Selumetinib Sulfate Drug: Tazemetostat Drug: Ulixertinib Drug: Vemurafenib | Phase 2 |
Show Detailed Description
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 1000 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Screening |
| Official Title: | NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) Screening Protocol |
| Actual Study Start Date : | July 24, 2017 |
| Estimated Primary Completion Date : | September 30, 2027 |
| Estimated Study Completion Date : | September 30, 2027 |
Resource links provided by the National Library of Medicine
Genetic and Rare Diseases Information Center resources:
Glioma
Lymphosarcoma
Soft Tissue Sarcoma
Osteosarcoma
Ependymoma
Medulloblastoma
Hepatoblastoma
Neuroblastoma
Ewing Sarcoma
Ewing's Family of Tumors
Rhabdoid Tumor
Neuroepithelioma
Wilms' Tumor
Langerhans Cell Histiocytosis
Malignant Germ Cell Tumor
Medulloblastoma, Childhood
Lipogranulomatosis
Non-Hodgkin Lymphoma, Childhood
| Arm | Intervention/treatment |
|---|---|
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Experimental: Subprotocol A (NTRK1, NTRK2, or NTRK3 gene fusion)
Patients with a NTRK1, NTRK2, or NTRK3 gene fusion receive Trk inhibitor LOXO-101 PO or via nasogastric- or gastric-tube BID on days 1-28. Courses repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.
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Procedure: Biopsy
Undergo biopsy
Other Name: Bx Procedure: Biospecimen Collection Undergo collection of blood Other: Laboratory Biomarker Analysis Undergo molecular analysis Drug: Larotrectinib Given PO or via nasogastric- or gastric-tube
Other Names:
Procedure: Mutation Carrier Screening Undergo tumor tissue mutation screening Other: Pharmacological Study Correlative studies |
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Experimental: Subprotocol B (FGFR1, FGFR2, FGFR3, or FGFR4 gene mutation)
Patients with a FGFR1, FGFR2, FGFR3, or FGFR4 gene mutation receive pan-FGFR tyrosine kinase inhibitor JNJ-42756493 PO once daily on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
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Procedure: Biopsy
Undergo biopsy
Other Name: Bx Procedure: Biospecimen Collection Undergo collection of blood Drug: Erdafitinib Given PO
Other Name: JNJ-42756493 Other: Laboratory Biomarker Analysis Undergo molecular analysis Procedure: Mutation Carrier Screening Undergo tumor tissue mutation screening Other: Pharmacological Study Correlative studies |
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Experimental: Subprotocol C (EZH2, SMARCB1, or SMARCA4 gene mutation)
Patients with an EZH2, SMARCB1, or SMARCA4 gene mutation receive tazemetostat PO BID on days 1-28. Courses repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.
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Procedure: Biopsy
Undergo biopsy
Other Name: Bx Procedure: Biospecimen Collection Undergo collection of blood Other: Laboratory Biomarker Analysis Undergo molecular analysis Procedure: Mutation Carrier Screening Undergo tumor tissue mutation screening Other: Pharmacological Study Correlative studies Drug: Tazemetostat Given PO
Other Names:
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Experimental: Subprotocol D (TSC1, TSC2, or PI3K/mTOR gene mutation)
Patients with a TSC1, TSC2, or PI3K/mTOR gene mutations receive PI3K/mTOR inhibitor LY3023414 PO BID on days 1-28. Courses repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.
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Procedure: Biopsy
Undergo biopsy
Other Name: Bx Procedure: Biospecimen Collection Undergo collection of blood Other: Laboratory Biomarker Analysis Undergo molecular analysis Procedure: Mutation Carrier Screening Undergo tumor tissue mutation screening Other: Pharmacological Study Correlative studies Drug: PI3K/mTOR Inhibitor LY3023414 Given PO
Other Names:
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Experimental: Subprotocol E (activating MAPK pathway gene mutation)
Patients with an activating MAPK pathway gene mutation receive selumetinib sulfate PO BID on days 1-28. Courses repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.
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Procedure: Biopsy
Undergo biopsy
Other Name: Bx Procedure: Biospecimen Collection Undergo collection of blood Other: Laboratory Biomarker Analysis Undergo molecular analysis Procedure: Mutation Carrier Screening Undergo tumor tissue mutation screening Other: Pharmacological Study Correlative studies Drug: Selumetinib Sulfate Given PO
Other Names:
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Experimental: Subprotocol F (ALK or ROS1 gene alteration)
Patients with an ALK or ROS1 gene alteration receive ensartinib (ALK Inhibitor X-396) PO BID on days 1-28. Courses repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.
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Procedure: Biopsy
Undergo biopsy
Other Name: Bx Procedure: Biospecimen Collection Undergo collection of blood Drug: Ensartinib Given PO
Other Name: X-396 Other: Laboratory Biomarker Analysis Undergo molecular analysis Procedure: Mutation Carrier Screening Undergo tumor tissue mutation screening Other: Pharmacological Study Correlative studies |
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Experimental: Subprotocol G (BRAF V600 gene mutation)
Patients with a BRAF V600 gene mutation receive vemurafenib PO BID on days 1-28. Courses repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.
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Procedure: Biopsy
Undergo biopsy
Other Name: Bx Procedure: Biospecimen Collection Undergo collection of blood Other: Laboratory Biomarker Analysis Undergo molecular analysis Procedure: Mutation Carrier Screening Undergo tumor tissue mutation screening Other: Pharmacological Study Correlative studies Drug: Vemurafenib Given PO
Other Names:
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Experimental: Subprotocol H (ATM, BRCA1, BRCA2, RAD51C, RAD51D mutations)
Patients deleterious ATM, BRCA1, BRCA2, RAD51C, or RAD51D gene mutations receive olaparib PO BID on days 1-28. Courses repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.
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Procedure: Biopsy
Undergo biopsy
Other Name: Bx Procedure: Biospecimen Collection Undergo collection of blood Other: Laboratory Biomarker Analysis Undergo molecular analysis Procedure: Mutation Carrier Screening Undergo tumor tissue mutation screening Drug: Olaparib Given PO
Other Names:
Other: Pharmacological Study Correlative studies |
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Experimental: Subprotocol I (Rb positive, alterations in cell cycle genes)
Patients with Rb positive advanced solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with activating alterations in cell cycle genes receive palbociclib PO QD on days 1-21. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
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Procedure: Biopsy
Undergo biopsy
Other Name: Bx Procedure: Biospecimen Collection Undergo collection of blood Other: Laboratory Biomarker Analysis Undergo molecular analysis Procedure: Mutation Carrier Screening Undergo tumor tissue mutation screening Drug: Palbociclib Given PO
Other Names:
Other: Pharmacological Study Correlative studies |
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Experimental: Subprotocol J (MAPK pathway mutations)
Patients with MAPK pathway mutations receive ulixertinib PO BID. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
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Procedure: Biopsy
Undergo biopsy
Other Name: Bx Procedure: Biospecimen Collection Undergo collection of blood Other: Laboratory Biomarker Analysis Undergo molecular analysis Procedure: Mutation Carrier Screening Undergo tumor tissue mutation screening Other: Pharmacological Study Correlative studies Drug: Ulixertinib Receive PO
Other Names:
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Primary Outcome Measures :
- Objective response rate (complete response/partial response) assessed according to Response Evaluation Criteria in Solid Tumors version 1.1 [ Time Frame: Up to 4 years ]Response rates will be calculated as the percent of evaluable patients who are responders, and confidence intervals will be constructed using the Wilson score interval method.
Secondary Outcome Measures :
- Incidence of toxicity assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 [ Time Frame: Up to 4 years ]Toxicity tables will be constructed to summarize the observed incidence by type of toxicity and grade. Toxicity information recorded will include the type, severity, time of onset, time of resolution, and the probable association with the study regimen.
- Incidence of research biopsy related target toxicity [ Time Frame: Up to 14 days ]Defined as any >= grade 3 toxicity or complication that is probably or definitely attributable to any biopsy-related anesthesia or imaging procedures that occurs within 14 days of research.
- Progression free survival (PFS) [ Time Frame: From the initiation of protocol treatment to the occurrence of any of the following events: disease progression or disease recurrence or death from any cause, assessed up to 4 years ]Will be estimated using the Kaplan-Meier method along with confidence intervals.
- Pharmacokinetic (PK) parameters [ Time Frame: Up to 4 years ]A descriptive analysis of PK parameters will be performed in specific subprotocols to define systemic exposure, drug clearance, and other pharmacokinetic parameters.
Other Outcome Measures:
- Genomic landscape of advanced pediatric solid tumors, non-Hodgkin lymphomas, and histiocytic disorders [ Time Frame: Up to 4 years ]A descriptive analysis will be performed and will be summarized with simple summary statistics. This analysis will be descriptive in nature.
- Change in genomics in advanced pediatric cancers [ Time Frame: Baseline up to 4 years ]A descriptive analysis will be performed and will be summarized with simple summary statistics. This analysis will be descriptive in nature.
- Diagnostic and profiling genomics of tumor approach as evaluated through circulating tumor deoxyribonucleic acid (DNA) [ Time Frame: Up to 4 years ]A descriptive analysis will be performed and will be summarized with simple summary statistics. This analysis will be descriptive in nature.
- Frequency of germline cancer susceptibility mutations in children with relapsed solid tumors and non-Hodgkin lymphomas [ Time Frame: Up to 4 years ]A descriptive analysis will be performed and will be summarized with simple summary statistics. This analysis will be descriptive in nature. Will assess the feasibility of return of the results in the National Clinical Trial Network (NCTN) group setting.
- Spectrum of germline cancer susceptibility mutations in children with relapsed solid tumors and non-Hodgkin lymphomas [ Time Frame: Up to 4 years ]A descriptive analysis will be performed and will be summarized with simple summary statistics. This analysis will be descriptive in nature. Will assess the feasibility of return of the results in the NCTN group setting.
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| Ages Eligible for Study: | 12 Months to 21 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- ELIGIBILITY CRITERIA FOR ENROLLMENT ONTO APEC1621SC: Patients with recurrent or refractory solid tumors, including non-Hodgkin lymphomas, histiocytoses (e.g. langerhans cell histiocytosis [LCH], juvenile xanthogranuloma [JXG], histiocytic sarcoma), and central nervous system (CNS) tumors are eligible; patients must have had histologic verification of malignancy at original diagnosis or relapse except in patients with intrinsic brain stem tumors, optic pathway gliomas, or patients with pineal tumors and elevations of cerebrospinal fluid (CSF) or serum tumor markers including alpha-fetoprotein or beta-human chorionic gonadotropin (HCG); please note: Patients with Hodgkin lymphoma are not eligible
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ELIGIBILITY CRITERIA FOR ENROLLMENT ONTO APEC1621SC: Patients must have an formalin-fixed paraffin-embedded (FFPE) tumor sample available for MATCH study testing from a biopsy or surgery that was performed at any point after initial tumor recurrence/progression, or be planned to have a procedure to obtain such a sample that is considered to be of potential benefit by the treating clinicians; a tumor sample from a clinically performed diagnostic (pre-treatment) biopsy will be acceptable for enrollment onto Pediatric MATCH only for children with high-grade gliomas of the brainstem (diffuse intrinsic pontine gliomas) or thalamus
- Please note: Samples that have been decalcified using standardly utilized acid-based decalcification methods are not generally suitable for MATCH study testing; the nucleic acids will have been degraded in the decalcification process
- ELIGIBILITY CRITERIA FOR ENROLLMENT ONTO APEC1621SC: Karnofsky >= 50% for patients > 16 years of age and Lansky >= 50 for patients =< 16 years of age); note: neurologic deficits in patients with CNS tumors must have been stable for at least 7 days prior to study enrollment; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
- GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: NOTE: patient does not need to meet all subprotocol criteria at time of enrollment onto the APEC1621SC 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 12 weeks (84 days) of treatment assignment
- GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: Karnofsky >= 50% for patients > 16 years of age and Lansky >= 50 for patients =< 16 years of age); Note: neurologic deficits in patients with CNS tumors must have been stable for at least 7 days prior to study enrollment; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
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GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: At the time of treatment with subprotocol specified therapy, the patients must have radiographically measurable disease; patients with neuroblastoma who do not have measurable disease but have iobenguane (MIBG) positive (+) evaluable are eligible; measurable disease in patients with CNS involvement is defined as tumor that is measurable in two perpendicular diameters on magnetic resonance imaging (MRI) and visible on more than one slice
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Note: The following do not qualify as measurable disease:
- Malignant fluid collections (e.g., ascites, pleural effusions)
- Bone marrow infiltration except that detected by MIBG scan for neuroblastoma
- Lesions only detected by nuclear medicine studies (e.g., bone, gallium or positron emission tomography [PET] scans) except as noted for neuroblastoma
- Elevated tumor markers in plasma or CSF
- Previously radiated lesions that have not demonstrated clear progression post radiation
- Leptomeningeal lesions that do not meet the measurement requirements for Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
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GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: At the time of enrollment onto a subprotocol, the following general criteria for initiation of therapy will be required:
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Patients must have fully recovered from the acute toxic effects of all prior anticancer therapy and must meet the following minimum duration from prior anticancer directed therapy prior to enrollment to the subprotocol; if after the required timeframe, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately
- Cytotoxic chemotherapy or other anticancer agents known to be myelosuppressive: for agents not listed, the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment >= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)
- Anticancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil counts [ANC]): >= 7 days after the last dose of agent; for agents not listed, the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment
- Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1
- Corticosteroids: If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid
- Hematopoietic growth factors: >= 14 days after the last dose of a long-acting growth factor (e.g. Neulasta) or 7 days for short-acting growth factor; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator
- Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)
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Stem cell infusions (with or without total-body irradiation [TBI]):
- Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 84 days after infusion and no evidence of graft versus host disease (GVHD)
- Autologous stem cell infusion including boost infusion: >= 42 days
- Cellular therapy: >= 42 days after the completion of any type of cellular therapy (e.g. modified T cells, NK cells, dendritic cells, etc.)
- X-ray therapy (XRT)/External Beam Irradiation including Protons: >= 14 days after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial bone marrow (BM) radiation; note: radiation may not be delivered to "measurable disease" tumor site(s) being used to follow response to subprotocol treatment
- Radiopharmaceutical therapy (e.g., radiolabeled antibody, 131I-MIBG): >= 42 days after systemically administered radiopharmaceutical therapy
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GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: For patients with solid tumors without known bone marrow involvement:
- Peripheral absolute neutrophil count (ANC) >= 1000/mm^3
- Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment
- GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions); these patients will not be evaluable for hematologic toxicity
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GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70ml/min/1.73 m^2 or a serum creatinine based on age/gender as follows:
- Age: 1 to < 2 years; maximum serum creatinine (mg/dL): male 0.6; female 0.6
- Age: 2 to < 6 years; maximum serum creatinine (mg/dL): male 0.8; female 0.8
- Age: 6 to < 10 years; maximum serum creatinine (mg/dL): male 1; female 1
- Age: 10 to < 13 years; maximum serum creatinine (mg/dL): male 1.2; female 1.2
- Age: 13 to < 16 years; maximum serum creatinine (mg/dL): male 1.5; female 1.4
- Age: >= 16 years; maximum serum creatinine (mg/dL): male 1.7; female 1.4
- GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age
- GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: Serum glutamate pyruvate transaminase (SGPT) (alanine transferase [ALT]) =< 135 U/L (for the purpose of this study, the ULN for SGPT is 45 U/L)
- GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: Patients must be able to swallow intact capsules/tablets, unless otherwise specified in the subprotocol to which they are assigned
- GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: Agent specific limitations on prior therapy will be included with specific treatment subprotocols
Exclusion Criteria:
- GENERAL EXCLUSION CRITERIA FOR SUBPROTOCOLS: Pregnant or breast-feeding women will not be entered on this study; pregnancy tests must be obtained in females who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method
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GENERAL EXCLUSION CRITERIA FOR SUBPROTOCOLS: Concomitant medications
- Corticosteroids: at the time of consent and enrollment to regimen specific subprotocols, patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment to the subprotocol will not be eligible; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid
- Investigational drugs: patients must meet criteria for prior therapy at the time of consent and enrollment to a subprotocol; other investigational agents may not be administered to patients while they are receiving study drug as part of a subprotocol
- Anticancer agents: patients must meet criteria for prior therapy at the time of consent and enrollment to a subprotocol; other investigational agents may not be administered to patients while they are receiving study drug as part of a subprotocol
- Anti-GVHD agents post-transplant: patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible
- GENERAL EXCLUSION CRITERIA FOR SUBPROTOCOLS: Patients who have an uncontrolled infection are not eligible
- GENERAL EXCLUSION CRITERIA FOR SUBPROTOCOLS: Patients who have had a prior solid organ transplant are not eligible
- GENERAL EXCLUSION CRITERIA FOR SUBPROTOCOLS: Additional agent specific criteria will be included with specific treatment subprotocols
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03155620
Show 123 Study Locations
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | Donald Parsons | Children's Oncology Group |
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT03155620 History of Changes |
| Other Study ID Numbers: |
NCI-2017-01251 NCI-2017-01251 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) APEC1621SC APEC1621SC ( Other Identifier: Childrens Oncology Group ) APEC1621SC ( Other Identifier: CTEP ) U10CA180886 ( U.S. NIH Grant/Contract ) |
| First Posted: | May 16, 2017 Key Record Dates |
| Last Update Posted: | December 13, 2018 |
| Last Verified: | November 2018 |
| Studies a U.S. FDA-regulated Drug Product: | Yes | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Additional relevant MeSH terms:
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Lymphoma Neoplasms Sarcoma Lymphoma, Non-Hodgkin Glioma Neuroblastoma Neoplasms, Germ Cell and Embryonal Osteosarcoma Rhabdomyosarcoma Ependymoma Sarcoma, Ewing Medulloblastoma Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Wilms Tumor |
Rhabdomyosarcoma, Embryonal Neuroectodermal Tumors, Primitive, Peripheral Rhabdoid Tumor Histiocytosis Histiocytosis, Langerhans-Cell Nervous System Neoplasms Central Nervous System Neoplasms Hepatoblastoma Histiocytic Sarcoma Xanthogranuloma, Juvenile Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |