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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
Recruitment Status : Recruiting
First Posted : May 16, 2017
Last Update Posted : December 14, 2018
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

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


Arm Intervention/treatment
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.
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:
  • ARRY 470
  • LOXO 101
  • LOXO-101

Procedure: Mutation Carrier Screening
Undergo tumor tissue mutation screening

Other: Pharmacological Study
Correlative studies

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.
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

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.
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:
  • E7438
  • EPZ-6438
  • EPZ6438

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.
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:
  • LY 3023414
  • LY-3023414
  • LY3023414

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.
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:
  • AZD-6244 Hydrogen Sulfate
  • AZD6244 Hydrogen Sulfate
  • AZD6244 Hydrogen Sulphate
  • Selumetinib Sulphate

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.
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

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.
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:
  • BRAF (V600E) kinase inhibitor RO5185426
  • BRAF(V600E) Kinase Inhibitor RO5185426
  • PLX-4032
  • PLX4032
  • RG 7204
  • RG7204
  • RO 5185426
  • Zelboraf

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.
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:
  • AZD2281
  • KU-0059436
  • Lynparza
  • PARP Inhibitor AZD2281

Other: Pharmacological Study
Correlative studies

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.
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:
  • Ibrance
  • PD-0332991
  • PD-332991

Other: Pharmacological Study
Correlative studies

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.
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:
  • BVD-523
  • VRT752271




Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.

  3. 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.

  4. 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:
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  • 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
  • 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

    • 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
  • GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: At the time of enrollment onto a subprotocol, the following general criteria for initiation of therapy will be required:

    • 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)
      • 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
  • 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
  • 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
  • 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


  Hide Study Locations
Locations
United States, Alabama
Children's Hospital of Alabama Suspended
Birmingham, Alabama, United States, 35233
United States, Arizona
Cardon Children's Medical Center Recruiting
Mesa, Arizona, United States, 85202
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Hardeo K. Panchoosingh         
Phoenix Childrens Hospital Suspended
Phoenix, Arizona, United States, 85016
United States, Arkansas
Arkansas Children's Hospital Suspended
Little Rock, Arkansas, United States, 72202-3591
United States, California
Kaiser Permanente Downey Medical Center Suspended
Downey, California, United States, 90242
Loma Linda University Medical Center Suspended
Loma Linda, California, United States, 92354
Miller Children's and Women's Hospital Long Beach Suspended
Long Beach, California, United States, 90806
Children's Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Leo Mascarenhas         
Valley Children's Hospital Recruiting
Madera, California, United States, 93636
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Vonda L. Crouse         
Children's Hospital and Research Center at Oakland Recruiting
Oakland, California, United States, 94609-1809
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Carla B. Golden         
Kaiser Permanente-Oakland Suspended
Oakland, California, United States, 94611
Lucile Packard Children's Hospital Stanford University Recruiting
Palo Alto, California, United States, 94304
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Sheri L. Spunt         
Rady Children's Hospital - San Diego Suspended
San Diego, California, United States, 92123
Naval Medical Center -San Diego Suspended
San Diego, California, United States, 92134
UCSF Medical Center-Mission Bay Recruiting
San Francisco, California, United States, 94158
Contact: Site Public Contact    877-827-3222      
Principal Investigator: Robert E. Goldsby         
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center Recruiting
Torrance, California, United States, 90502
Contact: Site Public Contact    310-222-3621      
Principal Investigator: Eduard H. Panosyan         
United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Margaret E. Macy         
United States, Connecticut
Connecticut Children's Medical Center Suspended
Hartford, Connecticut, United States, 06106
Yale University Suspended
New Haven, Connecticut, United States, 06520
United States, Delaware
Alfred I duPont Hospital for Children Suspended
Wilmington, Delaware, United States, 19803
United States, District of Columbia
Children's National Medical Center Suspended
Washington, District of Columbia, United States, 20010
United States, Florida
Golisano Children's Hospital of Southwest Florida Suspended
Fort Myers, Florida, United States, 33908
University of Florida Health Science Center - Gainesville Recruiting
Gainesville, Florida, United States, 32610
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: William B. Slayton         
Memorial Regional Hospital/Joe DiMaggio Children's Hospital Suspended
Hollywood, Florida, United States, 33021
Nemours Children's Clinic-Jacksonville Suspended
Jacksonville, Florida, United States, 32207
University of Miami Miller School of Medicine-Sylvester Cancer Center Suspended
Miami, Florida, United States, 33136
Nicklaus Children's Hospital Suspended
Miami, Florida, United States, 33155
Arnold Palmer Hospital for Children Suspended
Orlando, Florida, United States, 32806
Nemours Children's Hospital Suspended
Orlando, Florida, United States, 32827
Nemours Children's Clinic - Pensacola Active, not recruiting
Pensacola, Florida, United States, 32504
Johns Hopkins All Children's Hospital Suspended
Saint Petersburg, Florida, United States, 33701
Tampa General Hospital Suspended
Tampa, Florida, United States, 33606
Saint Joseph's Hospital/Children's Hospital-Tampa Recruiting
Tampa, Florida, United States, 33607
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Mark J. Mogul         
United States, Georgia
Children's Healthcare of Atlanta - Egleston Suspended
Atlanta, Georgia, United States, 30322
United States, Hawaii
Kapiolani Medical Center for Women and Children Recruiting
Honolulu, Hawaii, United States, 96826
Contact: Site Public Contact    808-983-6090      
Principal Investigator: Wade T. Kyono         
United States, Idaho
Saint Luke's Mountain States Tumor Institute Recruiting
Boise, Idaho, United States, 83712
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Eugenia Chang         
United States, Illinois
University of Chicago Comprehensive Cancer Center Suspended
Chicago, Illinois, United States, 60637
Loyola University Medical Center Suspended
Maywood, Illinois, United States, 60153
Saint Jude Midwest Affiliate Suspended
Peoria, Illinois, United States, 61637
United States, Indiana
Riley Hospital for Children Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Site Public Contact    800-248-1199      
Principal Investigator: Kamnesh R. Pradhan         
Saint Vincent Hospital and Health Care Center Suspended
Indianapolis, Indiana, United States, 46260
United States, Iowa
Blank Children's Hospital Suspended
Des Moines, Iowa, United States, 50309
University of Iowa/Holden Comprehensive Cancer Center Recruiting
Iowa City, Iowa, United States, 52242
Contact: Site Public Contact    800-237-1225      
Principal Investigator: Mariko Sato         
United States, Kentucky
University of Kentucky/Markey Cancer Center Suspended
Lexington, Kentucky, United States, 40536
Norton Children's Hospital Recruiting
Louisville, Kentucky, United States, 40202
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Ashok B. Raj         
United States, Louisiana
Ochsner Medical Center Jefferson Suspended
New Orleans, Louisiana, United States, 70121
United States, Maine
Maine Children's Cancer Program Suspended
Scarborough, Maine, United States, 04074
United States, Maryland
University of Maryland/Greenebaum Cancer Center Suspended
Baltimore, Maryland, United States, 21201
Sinai Hospital of Baltimore Suspended
Baltimore, Maryland, United States, 21215
Johns Hopkins University/Sidney Kimmel Cancer Center Suspended
Baltimore, Maryland, United States, 21287
National Institutes of Health Clinical Center Suspended
Bethesda, Maryland, United States, 20892
United States, Massachusetts
Massachusetts General Hospital Cancer Center Suspended
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute Suspended
Boston, Massachusetts, United States, 02215
University of Massachusetts Medical School Suspended
Worcester, Massachusetts, United States, 01655
United States, Michigan
C S Mott Children's Hospital Suspended
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Children's Hospitals and Clinics of Minnesota - Minneapolis Suspended
Minneapolis, Minnesota, United States, 55404
University of Minnesota/Masonic Cancer Center Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Emily G. Greengard         
Mayo Clinic Suspended
Rochester, Minnesota, United States, 55905
United States, Mississippi
University of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 39216
Contact: Site Public Contact    601-815-6700      
Principal Investigator: Anderson (Andy) B. Collier         
United States, Missouri
The Childrens Mercy Hospital Recruiting
Kansas City, Missouri, United States, 64108
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Jaszianne A. Tolbert         
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Site Public Contact    800-600-3606    info@siteman.wustl.edu   
Principal Investigator: Robert J. Hayashi         
Mercy Hospital Saint Louis Suspended
Saint Louis, Missouri, United States, 63141
United States, Nebraska
Children's Hospital and Medical Center of Omaha Recruiting
Omaha, Nebraska, United States, 68114
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Minnie Abromowitch         
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Site Public Contact    402-559-6941    unmcrsa@unmc.edu   
Principal Investigator: Minnie Abromowitch         
United States, Nevada
University Medical Center of Southern Nevada Suspended
Las Vegas, Nevada, United States, 89102
Alliance for Childhood Diseases/Cure 4 the Kids Foundation Suspended
Las Vegas, Nevada, United States, 89135
Summerlin Hospital Medical Center Suspended
Las Vegas, Nevada, United States, 89144
United States, New Hampshire
Dartmouth Hitchcock Medical Center Suspended
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Site Public Contact    201-996-2879      
Principal Investigator: Katharine Offer         
Morristown Medical Center Suspended
Morristown, New Jersey, United States, 07960
Saint Peter's University Hospital Suspended
New Brunswick, New Jersey, United States, 08901
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital Suspended
New Brunswick, New Jersey, United States, 08903
United States, New York
Roswell Park Cancer Institute Suspended
Buffalo, New York, United States, 14263
NYU Winthrop Hospital Recruiting
Mineola, New York, United States, 11501
Contact: Site Public Contact    516-663-3115      
Principal Investigator: Mark E. Weinblatt         
The Steven and Alexandra Cohen Children's Medical Center of New York Recruiting
New Hyde Park, New York, United States, 11040
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Julie I. Krystal         
Laura and Isaac Perlmutter Cancer Center at NYU Langone Recruiting
New York, New York, United States, 10016
Contact: Site Public Contact    212-263-4434    prmc.coordinator@nyumc.org   
Principal Investigator: Sharon L. Gardner         
Columbia University/Herbert Irving Cancer Center Recruiting
New York, New York, United States, 10032
Contact: Site Public Contact    212-305-6361    nr2616@cumc.columbia.edu   
Principal Investigator: Alice Lee         
Memorial Sloan Kettering Cancer Center Suspended
New York, New York, United States, 10065
University of Rochester Suspended
Rochester, New York, United States, 14642
State University of New York Upstate Medical University Recruiting
Syracuse, New York, United States, 13210
Contact: Site Public Contact    315-464-5476      
Principal Investigator: Philip M. Monteleone         
New York Medical College Suspended
Valhalla, New York, United States, 10595
United States, North Carolina
Mission Hospital Inc-Memorial Campus Recruiting
Asheville, North Carolina, United States, 28801
Contact: Site Public Contact    828-213-4150    leslie.verner@msj.org   
Principal Investigator: Douglas J. Scothorn         
UNC Lineberger Comprehensive Cancer Center Suspended
Chapel Hill, North Carolina, United States, 27599
Novant Health Presbyterian Medical Center Suspended
Charlotte, North Carolina, United States, 28204
Duke University Medical Center Suspended
Durham, North Carolina, United States, 27710
United States, Ohio
Children's Hospital Medical Center of Akron Suspended
Akron, Ohio, United States, 44308
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Erin H. Breese         
Rainbow Babies and Childrens Hospital Suspended
Cleveland, Ohio, United States, 44106
Cleveland Clinic Foundation Suspended
Cleveland, Ohio, United States, 44195
Nationwide Children's Hospital Suspended
Columbus, Ohio, United States, 43205
Dayton Children's Hospital Suspended
Dayton, Ohio, United States, 45404
The Toledo Hospital/Toledo Children's Hospital Recruiting
Toledo, Ohio, United States, 43606
Contact: Site Public Contact    419-824-1842      
Principal Investigator: Jamie L. Dargart         
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Site Public Contact    405-271-8777    ou-clinical-trials@ouhsc.edu   
Principal Investigator: Rene Y. McNall-Knapp         
United States, Oregon
Legacy Emanuel Children's Hospital Suspended
Portland, Oregon, United States, 97227
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Site Public Contact    503-494-1080    trials@ohsu.edu   
Principal Investigator: Linda C. Stork         
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Elizabeth Fox         
Children's Hospital of Pittsburgh of UPMC Suspended
Pittsburgh, Pennsylvania, United States, 15224
United States, Rhode Island
Rhode Island Hospital Suspended
Providence, Rhode Island, United States, 02903
United States, South Carolina
BI-LO Charities Children's Cancer Center Suspended
Greenville, South Carolina, United States, 29605
United States, South Dakota
Sanford USD Medical Center - Sioux Falls Suspended
Sioux Falls, South Dakota, United States, 57117-5134
United States, Tennessee
East Tennessee Childrens Hospital Suspended
Knoxville, Tennessee, United States, 37916
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Alberto S. Pappo         
The Children's Hospital at TriStar Centennial Suspended
Nashville, Tennessee, United States, 37203
Vanderbilt University/Ingram Cancer Center Suspended
Nashville, Tennessee, United States, 37232
United States, Texas
Dell Children's Medical Center of Central Texas Suspended
Austin, Texas, United States, 78723
Medical City Dallas Hospital Recruiting
Dallas, Texas, United States, 75230
Contact: Site Public Contact    972-566-5588      
Principal Investigator: Stanton C. Goldman         
UT Southwestern/Simmons Cancer Center-Dallas Recruiting
Dallas, Texas, United States, 75390
Contact: Site Public Contact    214-648-7097    canceranswerline@UTSouthwestern.edu   
Principal Investigator: Theodore W. Laetsch         
Cook Children's Medical Center Suspended
Fort Worth, Texas, United States, 76104
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Site Public Contact    713-798-1354    burton@bcm.edu   
Principal Investigator: Jodi Muscal         
Children's Hospital of San Antonio Recruiting
San Antonio, Texas, United States, 78207
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Timothy C. Griffin         
Methodist Children's Hospital of South Texas Suspended
San Antonio, Texas, United States, 78229
University of Texas Health Science Center at San Antonio Suspended
San Antonio, Texas, United States, 78229
United States, Vermont
University of Vermont College of Medicine Suspended
Burlington, Vermont, United States, 05405
United States, Virginia
Children's Hospital of The King's Daughters Recruiting
Norfolk, Virginia, United States, 23507
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Eric J. Lowe         
Virginia Commonwealth University/Massey Cancer Center Suspended
Richmond, Virginia, United States, 23298
United States, Washington
Seattle Children's Hospital Suspended
Seattle, Washington, United States, 98105
Providence Sacred Heart Medical Center and Children's Hospital Recruiting
Spokane, Washington, United States, 99204
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Judy L. Felgenhauer         
Madigan Army Medical Center Recruiting
Tacoma, Washington, United States, 98431
Contact: Site Public Contact    253-968-0129    mamcdci@amedd.army.mil   
Principal Investigator: Melissa A. Forouhar         
United States, West Virginia
West Virginia University Healthcare Suspended
Morgantown, West Virginia, United States, 26506
United States, Wisconsin
University of Wisconsin Hospital and Clinics Recruiting
Madison, Wisconsin, United States, 53792
Contact: Site Public Contact    800-622-8922      
Principal Investigator: Kenneth B. De Santes         
Children's Hospital of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Site Public Contact    414-955-4727    MACCCTO@mcw.edu   
Principal Investigator: Paul D. Harker-Murray         
Puerto Rico
San Jorge Children's Hospital Suspended
San Juan, Puerto Rico, 00912
University Pediatric Hospital Suspended
San Juan, Puerto Rico, 00926
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 14, 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:
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