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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 : May 15, 2020
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 Non-Hodgkin Lymphoma Ann Arbor Stage IV Non-Hodgkin Lymphoma Histiocytic Sarcoma Juvenile Xanthogranuloma Langerhans Cell Histiocytosis Malignant Glioma Recurrent Childhood Rhabdomyosarcoma Recurrent Ependymoma Recurrent Ewing Sarcoma Recurrent Glioma Recurrent Hepatoblastoma Recurrent Langerhans Cell Histiocytosis Recurrent Malignant Germ Cell Tumor Recurrent Malignant Solid Neoplasm Recurrent Medulloblastoma Recurrent Neuroblastoma Recurrent Non-Hodgkin Lymphoma Recurrent Osteosarcoma Recurrent Peripheral Primitive Neuroectodermal Tumor Recurrent Primary Central Nervous System Neoplasm Recurrent Rhabdoid Tumor Recurrent Soft Tissue Sarcoma Refractory Ewing Sarcoma Refractory Glioma Refractory Hepatoblastoma Refractory Langerhans Cell Histiocytosis Refractory Malignant Germ Cell Tumor Refractory Malignant Solid Neoplasm Refractory Medulloblastoma Refractory Neuroblastoma Refractory Non-Hodgkin Lymphoma Refractory Osteosarcoma Refractory Peripheral Primitive Neuroectodermal Tumor Refractory Primary Central Nervous System Neoplasm 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: Samotolisib Drug: Selpercatinib Drug: Selumetinib Sulfate Drug: Tazemetostat Drug: Tipifarnib Drug: Ulixertinib Drug: Vemurafenib Phase 2

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Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 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: Subprotcol M (HRAS gene alterations)
Patients receive tipifarnib PO or via nasogastric or gastric tube BID on days 1-7 and 15-21. Treatment repeats every 28 days for up to 26 cycles (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: Tipifarnib
Given PO or via nasogastric or gastric tube
Other Names:
  • R115777
  • Zarnestra

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. Cycles 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. Cycles 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 Names:
  • Balversa
  • 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. Cycles 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. Cycles 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: Samotolisib
Given PO
Other Names:
  • 2H-Imidazo(4,5-C)quinolin-2-one, 1,3-Dihydro-8-(5-(1-hydroxy-1-methylethyl)-3-pyridinyl)-1-((2S)-2-methoxypropyl)-3-methyl-
  • LY 3023414
  • LY-3023414
  • LY3023414
  • WHO 10889

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. Cycles 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
  • Koselugo
  • 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. Cycles 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. Cycles 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. Cycles 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:
  • AZD 2281
  • AZD-2281
  • 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. Cycles 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:
  • 6-Acetyl-8-cyclopentyl-5-methyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)-8h-pyrido(2,3-d)pyrimidin-7-one
  • Ibrance
  • PD 0332991
  • PD 332991
  • PD 991
  • PD-0332991

Other: Pharmacological Study
Correlative studies

Experimental: Subprotocol J (MAPK pathway mutations)
Patients with MAPK pathway mutations receive ulixertinib PO BID. Cycles 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

Experimental: Subprotocol N (activating RET mutations)
Patients with activating RET gene alterations receive selpercatinib PO BID on days 1-28. Treatment repeats every 28 days for up to 26 cycles (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: Selpercatinib
Given PO
Other Names:
  • LOXO-292
  • RET Kinase Inhibitor LOXO-292




Primary Outcome Measures :
  1. Objective response rate (complete response/partial response) [ Time Frame: From enrollment to the end of treatment, up to 2 years on subprotocol ]
    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.

  2. Proportion of pediatric patients whose advanced tumors have pathway alterations that can be targeted by select anti-cancer drugs [ Time Frame: Up to 4 years ]
    Match rate will be calculated as the percent of eligible patients who have an actionable mutation of interest and are matched to at least one of the subprotocols, and confidence intervals will be constructed using the Wilson score interval method.


Secondary Outcome Measures :
  1. Percentage of patients with grade 3 or 4 adverse events [ Time Frame: From enrollment to the end of treatment, up to 2 years on subprotocol ]
    Will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. All patients who receive at least one dose of protocol therapy will be considered in the evaluation of toxicity.

  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 [ Time Frame: Up to 4 years ]
    Will be evaluated through circulating tumor deoxyribonucleic acid (DNA). 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.


Layout table for eligibility information
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); in cases where patient enrolls prior to histologic confirmation of recurrent disease, patient is ineligible and should be withdrawn from study if histology fails to confirm recurrence; please note: Patients with Hodgkin lymphoma and plexiform neurofibroma 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
  • ELIGIBILITY CRITERIA FOR ENROLLMENT ONTO APEC1621SC: Patients must have radiographically measurable disease; measurable disease based on imaging obtained less than or equal to 56 days prior to enrollment; patients with neuroblastoma who do not have measurable disease but have metaiodobenzylguanidine (MIBG) positive (+) evaluable disease are eligible; measurable disease in patients with central nervous system (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: 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 8 weeks (56 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 MIBG+ evaluable are eligible; measurable disease in patients with CNS involvement is defined as tumor that is measurable in two perpendicular diameters on 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 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) >= 70 ml/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 due to risks of fetal and teratogenic adverse events as seen in animal/human studies, or because there is currently no available information regarding human fetal or teratogenic toxicities; 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


Locations
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Layout table for location information
United States, Alabama
Children's Hospital of Alabama Recruiting
Birmingham, Alabama, United States, 35233
Contact: Site Public Contact    205-638-9285    oncologyresearch@peds.uab.edu   
Principal Investigator: Elizabeth D. Alva         
United States, Alaska
Providence Alaska Medical Center Recruiting
Anchorage, Alaska, United States, 99508
Contact: Site Public Contact    907-212-6871    AKPAMC.OncologyResearchSupport@providence.org   
Principal Investigator: Brenda J. Wittman         
United States, Arizona
Cardon Children's Medical Center Recruiting
Mesa, Arizona, United States, 85202
Contact: Site Public Contact    602-747-9738      
Principal Investigator: Joseph C. Torkildson         
Phoenix Childrens Hospital Recruiting
Phoenix, Arizona, United States, 85016
Contact: Site Public Contact    602-546-0920      
Principal Investigator: Jessica Boklan         
Banner University Medical Center - Tucson Recruiting
Tucson, Arizona, United States, 85719
Contact: Site Public Contact       aselegue@email.arizona.edu   
Principal Investigator: Holly E. Pariury         
United States, Arkansas
Arkansas Children's Hospital Recruiting
Little Rock, Arkansas, United States, 72202-3591
Contact: Site Public Contact    501-364-7373      
Principal Investigator: David L. Becton         
United States, California
Kaiser Permanente Downey Medical Center Recruiting
Downey, California, United States, 90242
Contact: Site Public Contact    626-564-3455      
Principal Investigator: Robert M. Cooper         
City of Hope Comprehensive Cancer Center Recruiting
Duarte, California, United States, 91010
Contact: Site Public Contact    800-826-4673    becomingapatient@coh.org   
Principal Investigator: Anna B. Pawlowska         
Loma Linda University Medical Center Recruiting
Loma Linda, California, United States, 92354
Contact: Site Public Contact    909-558-3375      
Principal Investigator: Albert Kheradpour         
Miller Children's and Women's Hospital Long Beach Recruiting
Long Beach, California, United States, 90806
Contact: Site Public Contact    562-933-5600      
Principal Investigator: Jacqueline N. Casillas         
Children's Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Site Public Contact    323-361-4110      
Principal Investigator: Fariba Navid         
Cedars Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Site Public Contact    310-423-8965      
Principal Investigator: Fataneh (Fae) Majlessipour         
Mattel Children's Hospital UCLA Recruiting
Los Angeles, California, United States, 90095
Contact: Site Public Contact    310-825-6708      
Principal Investigator: William A. May         
Valley Children's Hospital Recruiting
Madera, California, United States, 93636
Contact: Site Public Contact    559-353-3000    Research@valleychildrens.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    510-428-3324    cgolden@mail.cho.org   
Principal Investigator: Carla B. Golden         
Kaiser Permanente-Oakland Recruiting
Oakland, California, United States, 94611
Contact: Site Public Contact    877-642-4691    Kpoct@kp.org   
Principal Investigator: Laura A. Campbell         
Children's Hospital of Orange County Recruiting
Orange, California, United States, 92868
Contact: Site Public Contact    714-997-3000      
Principal Investigator: Elyssa M. Rubin         
Lucile Packard Children's Hospital Stanford University Recruiting
Palo Alto, California, United States, 94304
Contact: Site Public Contact    800-694-0012    ccto-office@stanford.edu   
Principal Investigator: Jay Michael S. Balagtas         
University of California Davis Comprehensive Cancer Center Recruiting
Sacramento, California, United States, 95817
Contact: Site Public Contact    916-734-3089      
Principal Investigator: Marcio H. Malogolowkin         
Rady Children's Hospital - San Diego Recruiting
San Diego, California, United States, 92123
Contact: Site Public Contact    858-966-5934      
Principal Investigator: William D. Roberts         
Naval Medical Center -San Diego Recruiting
San Diego, California, United States, 92134
Contact: Site Public Contact    619-532-8712      
Principal Investigator: Yoko T. Udaka         
UCSF Medical Center-Mission Bay Recruiting
San Francisco, California, United States, 94158
Contact: Site Public Contact    877-827-3222      
Principal Investigator: Arun A. Rangaswami         
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Recruiting
Torrance, California, United States, 90502
Contact: Site Public Contact    310-222-3624    irb@lundquist.org   
Principal Investigator: Eduard H. Panosyan         
United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Site Public Contact    303-764-5056    josh.b.gordon@nsmtp.kp.org   
Principal Investigator: Margaret E. Macy         
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Recruiting
Denver, Colorado, United States, 80218
Contact: Site Public Contact    303-839-6000      
Principal Investigator: Jennifer J. Clark         
United States, Connecticut
Connecticut Children's Medical Center Recruiting
Hartford, Connecticut, United States, 06106
Contact: Site Public Contact    860-545-9981      
Principal Investigator: Michael S. Isakoff         
Yale University Recruiting
New Haven, Connecticut, United States, 06520
Contact: Site Public Contact    203-785-5702    canceranswers@yale.edu   
Principal Investigator: Nina S. Kadan-Lottick         
United States, Delaware
Alfred I duPont Hospital for Children Recruiting
Wilmington, Delaware, United States, 19803
Contact: Site Public Contact    302-651-6884    dperry@nemours.org   
Principal Investigator: Scott M. Bradfield         
United States, District of Columbia
Children's National Medical Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Site Public Contact    202-884-2549      
Principal Investigator: Jeffrey S. Dome         
United States, Florida
Broward Health Medical Center Recruiting
Fort Lauderdale, Florida, United States, 33316
Contact: Site Public Contact    954-355-5346      
Principal Investigator: Hector M. Rodriguez-Cortes         
Golisano Children's Hospital of Southwest Florida Recruiting
Fort Myers, Florida, United States, 33908
Contact: Site Public Contact    239-343-5333    molly.arnstrom@leehealth.org   
Principal Investigator: Emad K. Salman         
University of Florida Health Science Center - Gainesville Recruiting
Gainesville, Florida, United States, 32610
Contact: Site Public Contact    352-273-8010    cancer-center@ufl.edu   
Principal Investigator: William B. Slayton         
Memorial Regional Hospital/Joe DiMaggio Children's Hospital Recruiting
Hollywood, Florida, United States, 33021
Contact: Site Public Contact    954-265-1847    OHR@mhs.net   
Principal Investigator: Iftikhar Hanif         
Nemours Children's Clinic-Jacksonville Recruiting
Jacksonville, Florida, United States, 32207
Contact: Site Public Contact    904-697-3529      
Principal Investigator: Scott M. Bradfield         
University of Miami Miller School of Medicine-Sylvester Cancer Center Recruiting
Miami, Florida, United States, 33136
Contact: Site Public Contact    305-243-2647      
Principal Investigator: Julio C. Barredo         
Nicklaus Children's Hospital Recruiting
Miami, Florida, United States, 33155
Contact: Site Public Contact    888-624-2778      
Principal Investigator: Enrique A. Escalon         
AdventHealth Orlando Recruiting
Orlando, Florida, United States, 32803
Contact: Site Public Contact    407-303-2090    FH.Cancer.Research@flhosp.org   
Principal Investigator: Fouad M. Hajjar         
Arnold Palmer Hospital for Children Recruiting
Orlando, Florida, United States, 32806
Contact: Site Public Contact    321-843-2584    melissa.leffin@orlandohealth.com   
Principal Investigator: Amy A. Smith         
Nemours Children's Hospital Recruiting
Orlando, Florida, United States, 32827
Contact: Site Public Contact    407-650-7150      
Principal Investigator: Scott M. Bradfield         
Nemours Children's Clinic - Pensacola Active, not recruiting
Pensacola, Florida, United States, 32504
Johns Hopkins All Children's Hospital Recruiting
Saint Petersburg, Florida, United States, 33701
Contact: Site Public Contact    727-767-4784    Ashley.Repp@jhmi.edu   
Principal Investigator: Stacie L. Stapleton         
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    813-356-7168    Katelynn.Colgain@baycare.org   
Principal Investigator: Don E. Eslin         
Saint Mary's Hospital Recruiting
West Palm Beach, Florida, United States, 33407
Contact: Site Public Contact    561-881-2815      
Principal Investigator: Narayana Gowda         
United States, Georgia
Children's Healthcare of Atlanta - Egleston Recruiting
Atlanta, Georgia, United States, 30322
Contact: Site Public Contact    404-785-2025    Leann.Schilling@choa.org   
Principal Investigator: William T. Cash         
Memorial Health University Medical Center Recruiting
Savannah, Georgia, United States, 31404
Contact: Site Public Contact    912-350-7887    clayter1@memorialhealth.com   
Principal Investigator: Andrew L. Pendleton         
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    208-381-2774    eslinget@slhs.org   
Principal Investigator: Eugenia Chang         
United States, Illinois
Lurie Children's Hospital-Chicago Recruiting
Chicago, Illinois, United States, 60611
Contact: Site Public Contact    773-880-4562      
Principal Investigator: David O. Walterhouse         
University of Illinois Recruiting
Chicago, Illinois, United States, 60612
Contact: Site Public Contact    312-355-3046      
Principal Investigator: Mary L. Schmidt         
University of Chicago Comprehensive Cancer Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Site Public Contact    773-702-8222    cancerclinicaltrials@bsd.uchicago.edu   
Principal Investigator: Susan L. Cohn         
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Site Public Contact    708-226-4357      
Principal Investigator: Eugene Suh         
Saint Jude Midwest Affiliate Recruiting
Peoria, Illinois, United States, 61637
Contact: Site Public Contact    888-226-4343      
Principal Investigator: Jaime M. Libes         
Southern Illinois University School of Medicine Recruiting
Springfield, Illinois, United States, 62702
Contact: Site Public Contact    217-545-7929      
Principal Investigator: Gregory P. Brandt         
United States, Indiana
Riley Hospital for Children Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Site Public Contact    800-248-1199      
Principal Investigator: Sandeep Batra         
Saint Vincent Hospital and Health Care Center Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Site Public Contact    317-338-2194    research@stvincent.org   
Principal Investigator: Bassem I. Razzouk         
United States, Iowa
Blank Children's Hospital Recruiting
Des Moines, Iowa, United States, 50309
Contact: Site Public Contact    515-241-8912    samantha.mallory@unitypoint.org   
Principal Investigator: Samantha L. Mallory         
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 Recruiting
Lexington, Kentucky, United States, 40536
Contact: Site Public Contact    859-257-3379      
Principal Investigator: James T. Badgett         
Norton Children's Hospital Recruiting
Louisville, Kentucky, United States, 40202
Contact: Site Public Contact    502-629-5500    CancerResource@nortonhealthcare.org   
Principal Investigator: Ashok B. Raj         
United States, Louisiana
Children's Hospital New Orleans Recruiting
New Orleans, Louisiana, United States, 70118
Contact: Site Public Contact       CHResearch@lcmchealth.org   
Principal Investigator: Lolie C. Yu         
Ochsner Medical Center Jefferson Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Site Public Contact    504-703-8712    Gregory.Johnstone@ochsner.org   
Principal Investigator: Craig Lotterman         
United States, Maine
Eastern Maine Medical Center Recruiting
Bangor, Maine, United States, 04401
Contact: Site Public Contact    207-973-4274      
Principal Investigator: Nadine P. SantaCruz         
Maine Children's Cancer Program Recruiting
Scarborough, Maine, United States, 04074
Contact: Site Public Contact    207-396-7581    sverwys@mmc.org   
Principal Investigator: Eric C. Larsen         
United States, Maryland
University of Maryland/Greenebaum Cancer Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Site Public Contact    800-888-8823      
Principal Investigator: Teresa A. York         
Sinai Hospital of Baltimore Recruiting
Baltimore, Maryland, United States, 21215
Contact: Site Public Contact    410-601-6120    pridgely@lifebridgehealth.org   
Principal Investigator: Jason M. Fixler         
Johns Hopkins University/Sidney Kimmel Cancer Center Recruiting
Baltimore, Maryland, United States, 21287
Contact: Site Public Contact    410-955-8804    jhcccro@jhmi.edu   
Principal Investigator: Kenneth J. Cohen         
National Institutes of Health Clinical Center Suspended
Bethesda, Maryland, United States, 20892
United States, Massachusetts
Massachusetts General Hospital Cancer Center Recruiting
Boston, Massachusetts, United States, 02114
Contact: Site Public Contact    877-726-5130      
Principal Investigator: Katherine A. Janeway         
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Site Public Contact    877-442-3324      
Principal Investigator: Katherine A. Janeway         
UMass Memorial Medical Center - University Campus Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Site Public Contact    508-856-3216    cancer.research@umassmed.edu   
Principal Investigator: Stefanie R. Lowas         
United States, Michigan
C S Mott Children's Hospital Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Site Public Contact    800-865-1125      
Principal Investigator: Rajen Mody         
Wayne State University/Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Site Public Contact    313-576-9790    ctoadmin@karmanos.org   
Principal Investigator: Jeffrey W. Taub         
United States, Minnesota
Children's Hospitals and Clinics of Minnesota - Minneapolis Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Site Public Contact    612-813-5193      
Principal Investigator: Michael K. Richards         
University of Minnesota/Masonic Cancer Center Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Site Public Contact    612-624-2620      
Principal Investigator: Emily G. Greengard         
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Site Public Contact    855-776-0015      
Principal Investigator: Carola A. Arndt         
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
Children's Mercy Hospitals and Clinics Recruiting
Kansas City, Missouri, United States, 64108
Contact: Site Public Contact    816-302-6808    rryan@cmh.edu   
Principal Investigator: Kevin F. Ginn         
Cardinal Glennon Children's Medical Center Recruiting
Saint Louis, Missouri, United States, 63104
Contact: Site Public Contact    314-268-4000      
Principal Investigator: William S. Ferguson         
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 Recruiting
Saint Louis, Missouri, United States, 63141
Contact: Site Public Contact    314-251-7066      
Principal Investigator: Robin D. Hanson         
United States, Nebraska
Children's Hospital and Medical Center of Omaha Recruiting
Omaha, Nebraska, United States, 68114
Contact: Site Public Contact    402-955-3949      
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
Sunrise Hospital and Medical Center Recruiting
Las Vegas, Nevada, United States, 89109
Contact: Site Public Contact    702-384-0013    research@sncrf.org   
Principal Investigator: Alan K. Ikeda         
Alliance for Childhood Diseases/Cure 4 the Kids Foundation Recruiting
Las Vegas, Nevada, United States, 89135
Contact: Site Public Contact    702-384-0013    research@sncrf.org   
Principal Investigator: Alan K. Ikeda         
Summerlin Hospital Medical Center Recruiting
Las Vegas, Nevada, United States, 89144
Contact: Site Public Contact    702-384-0013    research@sncrf.org   
Principal Investigator: Alan K. Ikeda         
United States, New Hampshire
Dartmouth Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Site Public Contact    800-639-6918    cancer.research.nurse@dartmouth.edu   
Principal Investigator: Julie Kim         
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 Recruiting
Morristown, New Jersey, United States, 07960
Contact: Site Public Contact    973-971-5900      
Principal Investigator: John J. Gregory         
Saint Peter's University Hospital Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Site Public Contact    732-745-8600 ext 6163    kcovert@saintpetersuh.com   
Principal Investigator: Nibal A. Zaghloul         
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Site Public Contact    732-235-8675      
Principal Investigator: Jocelyn A. Lewis         
United States, New York
Albany Medical Center Recruiting
Albany, New York, United States, 12208
Contact: Site Public Contact    518-262-5513      
Principal Investigator: Lauren R. Weintraub         
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Site Public Contact    800-767-9355    askroswell@roswellpark.org   
Principal Investigator: Clare J. Twist         
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    718-470-3460      
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         
NYP/Columbia University Medical Center/Herbert Irving Comprehensive 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 Recruiting
New York, New York, United States, 10065
Contact: Site Public Contact    212-639-7592      
Principal Investigator: Christopher J. Forlenza         
NYP/Weill Cornell Medical Center Recruiting
New York, New York, United States, 10065
Contact: Site Public Contact    212-746-1848      
Principal Investigator: Alexander Aledo         
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Site Public Contact    585-275-5830      
Principal Investigator: Angela R. Girvin         
Stony Brook University Medical Center Recruiting
Stony Brook, New York, United States, 11794
Contact: Site Public Contact    800-862-2215      
Principal Investigator: Laura E. Hogan         
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 Recruiting
Valhalla, New York, United States, 10595
Contact: Site Public Contact    914-594-3794      
Principal Investigator: Jessica C. Hochberg         
United States, North Carolina
Mission Hospital Recruiting
Asheville, North Carolina, United States, 28801
Contact: Site Public Contact    828-418-1354    courtney.trafford@hcahealthcare.com   
Principal Investigator: Douglas J. Scothorn         
UNC Lineberger Comprehensive Cancer Center Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Site Public Contact    877-668-0683    cancerclinicaltrials@med.unc.edu   
Principal Investigator: Stuart H. Gold         
Carolinas Medical Center/Levine Cancer Institute Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Site Public Contact    800-804-9376      
Principal Investigator: Joel A. Kaplan         
Novant Health Presbyterian Medical Center Suspended
Charlotte, North Carolina, United States, 28204
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Site Public Contact    888-275-3853      
Principal Investigator: Lars M. Wagner         
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    513-636-2799    cancer@cchmc.org   
Principal Investigator: Erin H. Breese         
Rainbow Babies and Childrens Hospital Recruiting
Cleveland, Ohio, United States, 44106
Contact: Site Public Contact    216-844-5437      
Principal Investigator: Duncan S. Stearns         
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Site Public Contact    866-223-8100    CancerAnswer@ccf.org   
Principal Investigator: Rabi Hanna         
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Site Public Contact    614-072-2657    amy.yekisa@nationwidechildrens.org   
Principal Investigator: Mark A. Ranalli         
Dayton Children's Hospital Recruiting
Dayton, Ohio, United States, 45404
Contact: Site Public Contact    800-228-4055      
Principal Investigator: Ayman A. El-Sheikh         
ProMedica Toledo Hospital/Russell J Ebeid 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 Recruiting
Portland, Oregon, United States, 97227
Contact: Site Public Contact    503-413-2560      
Principal Investigator: Janice F. Olson         
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Site Public Contact    503-494-1080    trials@ohsu.edu   
Principal Investigator: Katrina Winsnes         
United States, Pennsylvania
Lehigh Valley Hospital-Cedar Crest Recruiting
Allentown, Pennsylvania, United States, 18103
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Felipe S. Bautista-Otanez         
Geisinger Medical Center Recruiting
Danville, Pennsylvania, United States, 17822
Contact: Site Public Contact    570-271-5251    HemonCCTrials@geisinger.edu   
Principal Investigator: Jagadeesh Ramdas         
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Site Public Contact    267-425-5544    CancerTrials@email.chop.edu   
Principal Investigator: Frank M. Balis         
Children's Hospital of Pittsburgh of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Site Public Contact    412-692-8570    jean.tersak@chp.edu   
Principal Investigator: Jean M. Tersak         
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Site Public Contact    401-444-1488      
Principal Investigator: Jennifer J. Greene Welch         
United States, South Carolina
BI-LO Charities Children's Cancer Center Recruiting
Greenville, South Carolina, United States, 29605
Contact: Site Public Contact    864-522-2066    kim.williams3@prismahealth.org   
Principal Investigator: Nichole L. Bryant         
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 Recruiting
Knoxville, Tennessee, United States, 37916
Contact: Site Public Contact    865-541-8266      
Principal Investigator: Ray C. Pais         
Saint Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Site Public Contact    888-226-4343    referralinfo@stjude.org   
Principal Investigator: Alberto S. Pappo         
The Children's Hospital at TriStar Centennial Recruiting
Nashville, Tennessee, United States, 37203
Contact: Site Public Contact    615-342-1919      
Principal Investigator: Haydar A. Frangoul         
Vanderbilt University/Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Site Public Contact    800-811-8480      
Principal Investigator: Scott C. Borinstein         
United States, Texas
Dell Children's Medical Center of Central Texas Recruiting
Austin, Texas, United States, 78723
Contact: Site Public Contact    512-628-1902    TXAUS-DL-SFCHemonc.research@ascension.org   
Principal Investigator: Shannon M. Cohn         
Driscoll Children's Hospital Recruiting
Corpus Christi, Texas, United States, 78411
Contact: Site Public Contact    361-694-5311    Crystal.DeLosSantos@dchstx.org   
Principal Investigator: Nkechi I. Mba         
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         
El Paso Children's Hospital Recruiting
El Paso, Texas, United States, 79905
Contact: Site Public Contact    915-298-5444    lisa.hartman@ttuhsc.edu   
Principal Investigator: Lisa L. Hartman         
Cook Children's Medical Center Recruiting
Fort Worth, Texas, United States, 76104
Contact: Site Public Contact    682-885-2103    CookChildrensResearch@cookchildrens.org   
Principal Investigator: Kelly L. Vallance         
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         
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Site Public Contact    877-632-6789    askmdanderson@mdanderson.org   
Principal Investigator: Pooja Hingorani         
Covenant Children's Hospital Recruiting
Lubbock, Texas, United States, 79410
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Kishor M. Bhende         
UMC Cancer Center / UMC Health System Recruiting
Lubbock, Texas, United States, 79415
Contact: Site Public Contact    806-775-8590      
Principal Investigator: Mohamad M. Al-Rahawan         
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 Recruiting
San Antonio, Texas, United States, 78229
Contact: Site Public Contact    210-575-6240    Vinod.GidvaniDiaz@hcahealthcare.com   
Principal Investigator: Vinod K. Gidvani-Diaz         
University of Texas Health Science Center at San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Site Public Contact    210-450-3800    phoresearchoffice@uthscsa.edu   
Principal Investigator: Anne-Marie R. Langevin         
Scott and White Memorial Hospital Recruiting
Temple, Texas, United States, 76508
Contact: Site Public Contact    254-724-5407      
Principal Investigator: Nicholas W. McGregor         
United States, Utah
Primary Children's Hospital Recruiting
Salt Lake City, Utah, United States, 84113
Contact: Site Public Contact    801-585-5270      
Principal Investigator: Phillip E. Barnette         
United States, Vermont
University of Vermont and State Agricultural College Recruiting
Burlington, Vermont, United States, 05405
Contact: Site Public Contact    802-656-8990    rpo@uvm.edu   
Principal Investigator: Jessica L. Heath         
United States, Virginia
Children's Hospital of The King's Daughters Recruiting
Norfolk, Virginia, United States, 23507
Contact: Site Public Contact    757-668-7243    CCBDCresearch@chkd.org   
Principal Investigator: Eric J. Lowe         
Naval Medical Center - Portsmouth Recruiting
Portsmouth, Virginia, United States, 23708-2197
Contact: Site Public Contact    757-953-5939      
Principal Investigator: Bethany M. Mikles         
Virginia Commonwealth University/Massey Cancer Center Recruiting
Richmond, Virginia, United States, 23298
Contact: Site Public Contact    804-628-1914    klcampbell@vcu.edu   
Principal Investigator: Gita V. Massey         
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Site Public Contact    866-987-2000      
Principal Investigator: Douglas S. Hawkins         
Providence Sacred Heart Medical Center and Children's Hospital Recruiting
Spokane, Washington, United States, 99204
Contact: Site Public Contact    800-228-6618    HopeBeginsHere@providence.org   
Principal Investigator: Judy L. Felgenhauer         
Mary Bridge Children's Hospital and Health Center Recruiting
Tacoma, Washington, United States, 98405
Contact: Site Public Contact    253-403-1461    research@multicare.org   
Principal Investigator: Robert G. Irwin         
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 Recruiting
San Juan, Puerto Rico, 00912
Contact: Site Public Contact    787-727-1000      
Principal Investigator: Luis A. Clavell         
University Pediatric Hospital Recruiting
San Juan, Puerto Rico, 00926
Contact: Site Public Contact    787-474-0333      
Principal Investigator: Luis A. Clavell         
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Donald W Parsons Children's Oncology Group

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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT03155620    
Other Study ID Numbers: NCI-2017-01251
NCI-2017-01251 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
APEC1621SC ( Other Identifier: Children's Oncology Group )
APEC1621SC ( Other Identifier: CTEP )
U10CA180886 ( U.S. NIH Grant/Contract )
First Posted: May 16, 2017    Key Record Dates
Last Update Posted: May 15, 2020
Last Verified: April 2020

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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
Sarcoma
Lymphoma, Non-Hodgkin
Glioma
Neuroblastoma
Neoplasms, Germ Cell and Embryonal
Osteosarcoma
Rhabdomyosarcoma
Ependymoma
Sarcoma, Ewing
Medulloblastoma
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Wilms Tumor
Neuroectodermal Tumors, Primitive, Peripheral
Rhabdoid Tumor
Nervous System Neoplasms
Hepatoblastoma
Central Nervous System Neoplasms
Histiocytic Sarcoma
Histiocytosis, Langerhans-Cell
Histiocytosis
Xanthogranuloma, Juvenile
Neoplasms
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms, Connective and Soft Tissue