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 : June 5, 2023

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Sponsor:

Information provided by (Responsible Party):

National Cancer Institute (NCI)

Study Description

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 Procedure: Bone Marrow Aspiration and Biopsy Procedure: Bone Scan Procedure: Computed Tomography Drug: Ensartinib Drug: Erdafitinib Other: Laboratory Biomarker Analysis Drug: Larotrectinib Sulfate Procedure: Magnetic Resonance Imaging Procedure: Mutation Carrier Screening Drug: Olaparib Drug: Palbociclib Other: Pharmacological Study Procedure: Positron Emission Tomography Procedure: Radionuclide Imaging Drug: Samotolisib Drug: Selpercatinib Drug: Selumetinib Sulfate Drug: Tazemetostat Drug: Tipifarnib Drug: Ulixertinib Drug: Vemurafenib Procedure: X-Ray Imaging	Phase 2

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Detailed Description:

PRIMARY OBJECTIVES:

I. To utilize clinical and biological data to screen for eligibility to phase 2 pathway-targeting specific subprotocols of pathway-targeting agents in pediatric patients with advanced solid tumors, non-Hodgkin lymphomas, and histiocytic disorders.

II. To determine the proportion of pediatric patients whose advanced tumors have pathway alterations that can be targeted by select anti-cancer drugs. (Completed) III. To determine the objective response rates (ORR; complete response + partial response) in pediatric patients with advanced solid tumors, non-Hodgkin lymphomas, and histiocytic disorders harboring a priori specified genomic alterations treated with pathway-targeting agents.

SECONDARY OBJECTIVES:

I. To estimate the progression free survival in pediatric patients receiving targeted therapies for advanced solid tumors, non-Hodgkin lymphomas, and histiocytic disorders.

II. To obtain preliminary or additional information about the tolerability of targeted therapies in children with advanced cancers.

III. To provide preliminary estimates of the pharmacokinetics of targeted therapies in children with advanced cancers.

IV. To obtain preliminary information on the response rate to targeted therapy in patients whose tumors lack actionable alterations as defined for the molecular analysis for therapy choice (MATCH) study, for selected agents for which efficacy is observed in the primary matched cohort.

EXPLORATORY OBJECTIVES:

I. To increase knowledge of the genomic landscape of advanced pediatric solid tumors, non-Hodgkin lymphomas, and histiocytic disorders.

II. To describe the genomic changes that occur in advanced pediatric cancers between the time of initial diagnosis and relapse, in cases for which paired tumor specimens are available.

III. To explore approaches to diagnosing and profiling genomics of advanced pediatric cancers through evaluation of circulating tumor deoxyribonucleic acid (DNA).

IV. To determine the frequency and spectrum of germline cancer susceptibility mutations in children with relapsed solid tumors and non-Hodgkin lymphomas and assess the feasibility of return of those results in the National Clinical Trial Network (NCTN) group setting.

OUTLINE:

STEP 1 (SCREENING): Patients undergo biopsy along with tumor mutational screening of the biopsy material for specific, pre-defined mutations, amplifications, or translocations of interest via tumor sequencing and immunohistochemistry. Patients also undergo collection of blood samples for research purposes.

STEP 2 (TREATMENT): Patients with a mutation targeted by one or more of the investigational drugs used in this study or those without mutations are assigned to 1 of 10 treatment subprotocols.

APEC1621A: Patients with a NTRK1, NTRK2, or NTRK3 gene fusion receive larotrectinib sulfate orally (PO) or via nasogastric- or gastric-tube twice daily (BID) on days 1-28. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.

APEC1621B: Patients with a FGFR1, FGFR2, FGFR3, or FGFR4 gene mutation receive erdafitinib PO once daily (QD) on days 1-28 of each cycle. Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Patients undergo an x-ray, computed tomography (CT scan), magnetic resonance imaging (MRI), radionuclide imaging, and/or bone scan, as well as a bone marrow aspiration and/or biopsy during screening and on study. Patients also undergo blood sample collection on study.

APEC1621C: 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.

APEC1621D: 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.

APEC1621E: 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.

APEC1621F: 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 (up to 26 cycles) in the absence of disease progression or unacceptable toxicity. Patients undergo an x-ray, CT scan, MRI, PET scan, radionuclide imaging, and/or bone scan, as well as a bone marrow aspiration and/or biopsy during screening and on study. Patients also undergo blood sample collection on study.

APEC1621G: 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.

APEC1621H: Patients with 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.

APEC1621I: 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.

APEC1621J: 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.

APEC1621M: Patients with HRAS gene alterations 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.

APEC1621N: 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. Patients may also undergo PET, CT, MRI, PET/CT, PET/MRI, and/or CT/MRI, scintigraphy, and x-ray imaging throughout the trial.

After completion of study treatment, patients are followed up periodically.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	2316 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Screening
Official Title:	NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) Screening Protocol
Actual Study Start Date :	July 24, 2017
Estimated Primary Completion Date :	September 30, 2027
Estimated Study Completion Date :	September 30, 2027

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Wilms tumor Ewing sarcoma Neuroblastoma

MedlinePlus related topics: Genetic Testing Lymphoma

Genetic and Rare Diseases Information Center resources: Lymphosarcoma Soft Tissue Sarcoma Glioma Ependymoma Malignant Germ Cell Tumor Osteosarcoma Neuroepithelioma Medulloblastoma Rhabdoid Tumor Ewing Sarcoma Langerhans Cell Histiocytosis Neuroblastoma Lipogranulomatosis Hepatoblastoma Wilms' Tumor Non-Langerhans-Cell Histiocytosis

U.S. FDA Resources

Arms and Interventions

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 Names: BIOPSY_TYPE Bx Procedure: Biospecimen Collection Undergo blood sample collection Other Names: Biological Sample Collection Biospecimen Collected Specimen Collection 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 larotrectinib sulfate 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 Names: BIOPSY_TYPE Bx Procedure: Biospecimen Collection Undergo blood sample collection Other Names: Biological Sample Collection Biospecimen Collected Specimen Collection Other: Laboratory Biomarker Analysis Undergo molecular analysis Drug: Larotrectinib Sulfate Given PO or via nasogastric- or gastric-tube Other Names: ARRY 470 Sulfate LOXO 101 Sulfate LOXO-101 Sulfate Vitrakvi 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 erdafitinib PO QD on days 1-28 of each cycle. Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Patients undergo an x-ray, CT scan, MRI, radionuclide imaging, and/or bone scan, as well as a bone marrow aspiration and/or biopsy during screening and on study. Patients also undergo blood sample collection on study.	Procedure: Biopsy Undergo biopsy Other Names: BIOPSY_TYPE Bx Procedure: Biospecimen Collection Undergo blood sample collection Other Names: Biological Sample Collection Biospecimen Collected Specimen Collection Procedure: Bone Marrow Aspiration and Biopsy Undergo a bone marrow and/or biopsy Procedure: Bone Scan Undergo a bone scan Other Name: Bone Scintigraphy Procedure: Computed Tomography Undergo CT, PET/Ct, and/or CT/MRI Other Names: CAT CAT Scan Computed Axial Tomography Computerized Axial Tomography Computerized axial tomography (procedure) Computerized Tomography CT CT Scan tomography Drug: Erdafitinib Given PO Other Names: Balversa JNJ-42756493 Other: Laboratory Biomarker Analysis Undergo molecular analysis Procedure: Magnetic Resonance Imaging Undergo MRI, PET/MRI, and/or CT/MRI Other Names: Magnetic Resonance Magnetic resonance imaging (procedure) Magnetic Resonance Imaging Scan Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance MR MR Imaging MRI MRI Scan NMR Imaging NMRI Nuclear Magnetic Resonance Imaging Procedure: Mutation Carrier Screening Undergo tumor tissue mutation screening Other: Pharmacological Study Correlative studies Procedure: Radionuclide Imaging Undergo radionuclide imaging Other Names: NM Nuclear Medicine nuclear medicine scan radioimaging Radionuclide Scanning Scan Scintigraphy Procedure: X-Ray Imaging Undergo an x-ray Other Names: Conventional X-Ray Diagnostic Radiology Medical Imaging, X-Ray Plain film radiographs Radiographic Imaging Radiographic imaging procedure (procedure) Radiography RG Static X-Ray X-Ray
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 Names: BIOPSY_TYPE Bx Procedure: Biospecimen Collection Undergo blood sample collection Other Names: Biological Sample Collection Biospecimen Collected Specimen Collection 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 Names: BIOPSY_TYPE Bx Procedure: Biospecimen Collection Undergo blood sample collection Other Names: Biological Sample Collection Biospecimen Collected Specimen Collection 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 Names: BIOPSY_TYPE Bx Procedure: Biospecimen Collection Undergo blood sample collection Other Names: Biological Sample Collection Biospecimen Collected Specimen Collection 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 PO BID on days 1-28. Cycles repeat every 28 days for 2 years (up to 26 cycles) in the absence of disease progression or unacceptable toxicity. Patients undergo an x-ray, CT scan, MRI, PET scan, radionuclide imaging, and/or bone scan, as well as a bone marrow aspiration and/or biopsy during screening and on study. Patients also undergo blood sample collection on study.	Procedure: Biopsy Undergo biopsy Other Names: BIOPSY_TYPE Bx Procedure: Biospecimen Collection Undergo blood sample collection Other Names: Biological Sample Collection Biospecimen Collected Specimen Collection Procedure: Bone Marrow Aspiration and Biopsy Undergo a bone marrow and/or biopsy Procedure: Bone Scan Undergo a bone scan Other Name: Bone Scintigraphy Procedure: Computed Tomography Undergo CT, PET/Ct, and/or CT/MRI Other Names: CAT CAT Scan Computed Axial Tomography Computerized Axial Tomography Computerized axial tomography (procedure) Computerized Tomography CT CT Scan tomography Drug: Ensartinib Given PO Other Name: X-396 Other: Laboratory Biomarker Analysis Undergo molecular analysis Procedure: Magnetic Resonance Imaging Undergo MRI, PET/MRI, and/or CT/MRI Other Names: Magnetic Resonance Magnetic resonance imaging (procedure) Magnetic Resonance Imaging Scan Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance MR MR Imaging MRI MRI Scan NMR Imaging NMRI Nuclear Magnetic Resonance Imaging Procedure: Mutation Carrier Screening Undergo tumor tissue mutation screening Other: Pharmacological Study Correlative studies Procedure: Positron Emission Tomography Undergo PET, PET/CT, and/or PET/MRI Other Names: Medical Imaging, Positron Emission Tomography PET PET Scan Positron emission tomography (procedure) Positron Emission Tomography Scan Positron-Emission Tomography proton magnetic resonance spectroscopic imaging PT Procedure: Radionuclide Imaging Undergo radionuclide imaging Other Names: NM Nuclear Medicine nuclear medicine scan radioimaging Radionuclide Scanning Scan Scintigraphy Procedure: X-Ray Imaging Undergo an x-ray Other Names: Conventional X-Ray Diagnostic Radiology Medical Imaging, X-Ray Plain film radiographs Radiographic Imaging Radiographic imaging procedure (procedure) Radiography RG Static X-Ray X-Ray
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 Names: BIOPSY_TYPE Bx Procedure: Biospecimen Collection Undergo blood sample collection Other Names: Biological Sample Collection Biospecimen Collected Specimen Collection 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 Names: BIOPSY_TYPE Bx Procedure: Biospecimen Collection Undergo blood sample collection Other Names: Biological Sample Collection Biospecimen Collected Specimen Collection 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 Names: BIOPSY_TYPE Bx Procedure: Biospecimen Collection Undergo blood sample collection Other Names: Biological Sample Collection Biospecimen Collected Specimen Collection 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 Names: BIOPSY_TYPE Bx Procedure: Biospecimen Collection Undergo blood sample collection Other Names: Biological Sample Collection Biospecimen Collected Specimen Collection 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. Patients may also undergo PET, CT, MRI, PET/CT, PET/MRI, and/or CT/MRI, scintigraphy, and x-ray imaging throughout the trial.	Procedure: Biopsy Undergo biopsy Other Names: BIOPSY_TYPE Bx Procedure: Biospecimen Collection Undergo blood sample collection Other Names: Biological Sample Collection Biospecimen Collected Specimen Collection Procedure: Computed Tomography Undergo CT, PET/Ct, and/or CT/MRI Other Names: CAT CAT Scan Computed Axial Tomography Computerized Axial Tomography Computerized axial tomography (procedure) Computerized Tomography CT CT Scan tomography Other: Laboratory Biomarker Analysis Undergo molecular analysis Procedure: Magnetic Resonance Imaging Undergo MRI, PET/MRI, and/or CT/MRI Other Names: Magnetic Resonance Magnetic resonance imaging (procedure) Magnetic Resonance Imaging Scan Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance MR MR Imaging MRI MRI Scan NMR Imaging NMRI Nuclear Magnetic Resonance Imaging Procedure: Mutation Carrier Screening Undergo tumor tissue mutation screening Other: Pharmacological Study Correlative studies Procedure: Positron Emission Tomography Undergo PET, PET/CT, and/or PET/MRI Other Names: Medical Imaging, Positron Emission Tomography PET PET Scan Positron emission tomography (procedure) Positron Emission Tomography Scan Positron-Emission Tomography proton magnetic resonance spectroscopic imaging PT Procedure: Radionuclide Imaging Undergo radionuclide imaging Other Names: NM Nuclear Medicine nuclear medicine scan radioimaging Radionuclide Scanning Scan Scintigraphy Drug: Selpercatinib Given PO Other Names: LOXO-292 RET Kinase Inhibitor LOXO-292 Retevmo WHO 10967 Procedure: X-Ray Imaging Undergo an x-ray Other Names: Conventional X-Ray Diagnostic Radiology Medical Imaging, X-Ray Plain film radiographs Radiographic Imaging Radiographic imaging procedure (procedure) Radiography RG Static X-Ray X-Ray

Outcome Measures

Primary Outcome Measures :

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.
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 :

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.
Incidence of research biopsy related target toxicity [ Time Frame: Up to 14 days ]
Defined as any >= grade 3 toxicity or complication that is probably or definitely attributable to any biopsy-related anesthesia or imaging procedures that occurs within 14 days of research.
Progression free survival (PFS) [ Time Frame: From the initiation of protocol treatment to the occurrence of any of the following events: disease progression or disease recurrence or death from any cause, assessed up to 4 years ]
Will be estimated using the Kaplan-Meier method along with confidence intervals.
Pharmacokinetic (PK) parameters [ Time Frame: Up to 4 years ]
A descriptive analysis of PK parameters will be performed in specific subprotocols to define systemic exposure, drug clearance, and other pharmacokinetic parameters.

Other Outcome Measures:

Genomic landscape of advanced pediatric solid tumors, non-Hodgkin lymphomas, and histiocytic disorders [ Time Frame: Up to 4 years ]
A descriptive analysis will be performed and will be summarized with simple summary statistics. This analysis will be descriptive in nature.
Change in genomics in advanced pediatric cancers [ Time Frame: Baseline up to 4 years ]
A descriptive analysis will be performed and will be summarized with simple summary statistics. This analysis will be descriptive in nature.
Diagnostic and profiling genomics of tumor approach [ 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.
Frequency of germline cancer susceptibility mutations in children with relapsed solid tumors and non-Hodgkin lymphomas [ Time Frame: Up to 4 years ]
A descriptive analysis will be performed and will be summarized with simple summary statistics. This analysis will be descriptive in nature. Will assess the feasibility of return of the results in the National Clinical Trial Network (NCTN) group setting.
Spectrum of germline cancer susceptibility mutations in children with relapsed solid tumors and non-Hodgkin lymphomas [ Time Frame: Up to 4 years ]
A descriptive analysis will be performed and will be summarized with simple summary statistics. This analysis will be descriptive in nature. Will assess the feasibility of return of the results in the NCTN group setting.

Eligibility Criteria

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Ages Eligible for Study:	12 Months to 21 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

ELIGIBILITY CRITERIA FOR ENROLLMENT ONTO APEC1621SC: Patients must be >= 12 months and =< 21 years of age at the time of study enrollment
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: Tumor Testing Requirement: Tumor sample availability requirement for stage 1 of Pediatric MATCH (patients enrolled from start of study in July 2017 through 12/31/21); 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: Tumor molecular profiling report availability requirement for Stage 2 of Pediatric MATCH (patients enrolled starting 2022): In stage 2 of the study, no tumor samples will be submitted for centralized clinical tumor profiling; instead, a tumor molecular profiling report from a College of American Pathologists (CAP)/ Clinical Laboratory Improvements Amendments (CLIA)-approved testing laboratory must be submitted for review by the Molecular Review Committee (MRC)
- This molecular profiling must have been performed on a tumor sample that was obtained at any point after initial tumor recurrence/progression and must be accompanied by a pathology report for the same tumor specimen; a molecular profiling report for a diagnostic (pre-treatment) tumor sample will be acceptable for enrollment onto Pediatric MATCH only for children with high-grade gliomas of the brainstem (diffuse intrinsic pontine gliomas) or thalamus. In the event that molecular profiling reports are available from multiple timepoints, the most recent report should be prioritized for study submission
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 central nervous system (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 CNS involvement is defined as any lesion that is at minimum 10 mm in one dimension on standard magnetic resonance imaging (MRI) or computed tomography (CT)
- 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 2 weeks (14 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 any lesion that is at minimum 10 mm in one dimension on standard MRI or CT
- 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, natural killer (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

Contacts and Locations

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

Hide 168 study locations

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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
Banner Children's at Desert	Recruiting
Mesa, Arizona, United States, 85202
Contact: Site Public Contact 480-412-3100
Principal Investigator: Joseph C. Torkildson
Phoenix Childrens Hospital	Recruiting
Phoenix, Arizona, United States, 85016
Contact: Site Public Contact 602-546-0920
Principal Investigator: Alok K. Kothari
Banner University Medical Center - Tucson	Recruiting
Tucson, Arizona, United States, 85719
Contact: Site Public Contact UACC-IIT@uacc.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	Active, not recruiting
Duarte, California, United States, 91010
Loma Linda University Medical Center	Recruiting
Loma Linda, California, United States, 92354
Contact: Site Public Contact 909-558-4050
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: Theodore B. Moore
Valley Children's Hospital	Recruiting
Madera, California, United States, 93636
Contact: Site Public Contact 559-353-3000 Research@valleychildrens.org
Principal Investigator: Karen S. Fernandez
UCSF Benioff Children's Hospital Oakland	Recruiting
Oakland, California, United States, 94609
Contact: Site Public Contact 510-428-3324 Carla.Golden@ucsf.edu
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: Aarati V. Rao
Children's Hospital of Orange County	Recruiting
Orange, California, United States, 92868
Contact: Site Public Contact 714-509-8646 oncresearch@choc.org
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 cancertrials@ucsf.edu
Principal Investigator: Arun A. Rangaswami
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center	Active, not recruiting
Torrance, California, United States, 90502
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: Farzana Pashankar
United States, Delaware
Alfred I duPont Hospital for Children	Recruiting
Wilmington, Delaware, United States, 19803
Contact: Site Public Contact 302-651-5572 Allison.bruce@nemours.org
Principal Investigator: Scott M. Bradfield
United States, District of Columbia
MedStar Georgetown University Hospital	Recruiting
Washington, District of Columbia, United States, 20007
Contact: Site Public Contact 202-444-2223
Principal Investigator: Nina S. Kadan-Lottick
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 302-651-5572 Allison.bruce@nemours.org
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 302-651-5572 Allison.bruce@nemours.org
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: Ziad A. Khatib
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 321-841-5357 Jennifer.spinelli@orlandohealth.com
Principal Investigator: Amy A. Smith
Nemours Children's Hospital	Recruiting
Orlando, Florida, United States, 32827
Contact: Site Public Contact 302-651-5572 Allison.bruce@nemours.org
Principal Investigator: Scott M. Bradfield
Nemours Children's Clinic - Pensacola	Active, not recruiting
Pensacola, Florida, United States, 32504
Sacred Heart Hospital	Recruiting
Pensacola, Florida, United States, 32504
Contact: Site Public Contact 850-416-4611 eebrou@ascension.org
Principal Investigator: Erlyn C. Smith
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	Recruiting
Tampa, Florida, United States, 33606
Contact: Site Public Contact 813-844-7829 syapchanyk@tgh.org
Principal Investigator: Juan F. Rico
Saint Joseph's Hospital/Children's Hospital-Tampa	Active, not recruiting
Tampa, Florida, United States, 33607
Saint Mary's Hospital	Recruiting
West Palm Beach, Florida, United States, 33407
Contact: Site Public Contact 561-881-2815
Principal Investigator: Muaz A. Alrazzak
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 Lorraine.OHara@hcahealthcare.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 Cancer Institute - Boise	Recruiting
Boise, Idaho, United States, 83712
Contact: Site Public Contact 208-381-2774 eslinget@slhs.org
Principal Investigator: Martha M. Pacheco
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: Prerna Kumar
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
Ascension Saint Vincent Indianapolis Hospital	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: David S. Dickens
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 504-842-8084 Elisemarie.curry@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
Michigan State University Clinical Center	Recruiting
East Lansing, Michigan, United States, 48824-7016
Contact: Site Public Contact 517-975-9547
Principal Investigator: Laura E. Agresta
Helen DeVos Children's Hospital at Spectrum Health	Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Site Public Contact 616-391-1230 crcwm-regulatory@crcwm.org
Principal Investigator: Kathleen J. Yost
Bronson Methodist Hospital	Recruiting
Kalamazoo, Michigan, United States, 49007
Contact: Site Public Contact 616-391-1230 crcwm-regulatory@crcwm.org
Principal Investigator: Kathleen J. Yost
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 in Rochester	Recruiting
Rochester, Minnesota, United States, 55905
Contact: Site Public Contact 855-776-0015
Principal Investigator: Wendy Allen-Rhoades
United States, Mississippi
University of Mississippi Medical Center	Recruiting
Jackson, Mississippi, United States, 39216
Contact: Site Public Contact 601-815-6700
Principal Investigator: Betty L. Herrington
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: Amy Armstrong
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: Jill C. Beck
University of Nebraska Medical Center	Recruiting
Omaha, Nebraska, United States, 68198
Contact: Site Public Contact 402-559-6941 unmcrsa@unmc.edu
Principal Investigator: Jill C. Beck
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/Dartmouth Cancer Center	Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Site Public Contact 800-639-6918 cancer.research.nurse@dartmouth.edu
Principal Investigator: Angela Ricci
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: Kathryn L. Laurie
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: Richard A. Drachtman
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
Montefiore Medical Center - Moses Campus	Recruiting
Bronx, New York, United States, 10467
Contact: Site Public Contact 718-379-6866 eskwak@montefiore.org
Principal Investigator: Lisa Gennarini
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	Active, not recruiting
Mineola, New York, United States, 11501
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 CancerTrials@nyulangone.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: Nobuko Hijiya
Memorial Sloan Kettering Cancer Center	Recruiting
New York, New York, United States, 10065
Contact: Site Public Contact 212-639-7592
Principal Investigator: Tara O'Donohue
NYP/Weill Cornell Medical Center	Recruiting
New York, New York, United States, 10065
Contact: Site Public Contact 212-746-1848
Principal Investigator: Alexander J. Chou
University of Rochester	Recruiting
Rochester, New York, United States, 14642
Contact: Site Public Contact 585-275-5830
Principal Investigator: Craig A. Mullen
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 828-213-7055 NCDV.ResearchRegulatory@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	Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Site Public Contact 980-201-6360 kashah@novanthealth.org
Principal Investigator: Jessica A. Bell
Duke University Medical Center	Recruiting
Durham, North Carolina, United States, 27710
Contact: Site Public Contact 888-275-3853
Principal Investigator: Lars M. Wagner
East Carolina University	Recruiting
Greenville, North Carolina, United States, 27834
Contact: Site Public Contact 252-744-1015 eubankss@ecu.edu
Principal Investigator: Andrea R. Whitfield
Wake Forest University Health Sciences	Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Site Public Contact 336-713-6771
Principal Investigator: Thomas W. McLean
United States, Ohio
Children's Hospital Medical Center of Akron	Recruiting
Akron, Ohio, United States, 44308
Contact: Site Public Contact 330-543-3193
Principal Investigator: Erin Wright
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 TaussigResearch@ccf.org
Principal Investigator: Rabi Hanna
Nationwide Children's Hospital	Recruiting
Columbus, Ohio, United States, 43205
Contact: Site Public Contact 614-722-6039 Melinda.Triplet@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: Mukund G. Dole
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital	Recruiting
Toledo, Ohio, United States, 43606
Contact: Site Public Contact 419-824-1842 PCIOncResearch@promedica.org
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 610-402-9543 Morgan_M.Horton@lvhn.org
Principal Investigator: Jacob A. Troutman
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. Welch
United States, South Carolina
Prisma Health Richland Hospital	Recruiting
Columbia, South Carolina, United States, 29203
Contact: Site Public Contact 864-241-6251
Principal Investigator: Stuart L. Cramer
BI-LO Charities Children's Cancer Center	Recruiting
Greenville, South Carolina, United States, 29605
Contact: Site Public Contact 864-241-6251
Principal Investigator: Aniket Saha
United States, South Dakota
Sanford USD Medical Center - Sioux Falls	Recruiting
Sioux Falls, South Dakota, United States, 57117-5134
Contact: Site Public Contact 605-312-3320 OncologyClinicalTrialsSF@SanfordHealth.org
Principal Investigator: Kayelyn J. Wagner
United States, Tennessee
East Tennessee Childrens Hospital	Recruiting
Knoxville, Tennessee, United States, 37916
Contact: Site Public Contact 865-541-8266
Principal Investigator: Susan E. Spiller
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: Jennifer A. Domm
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: Avanthi T. Shah
El Paso Children's Hospital	Recruiting
El Paso, Texas, United States, 79905
Contact: Site Public Contact 915-298-5444 ranjan.bista@ttuhsc.edu
Principal Investigator: Ranjan Bista
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: Jennifer H. Foster
M D Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Contact: Site Public Contact 877-632-6789 askmdanderson@mdanderson.org
Principal Investigator: Najat C. Daw
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: Erin K. Barr
Children's Hospital of San Antonio	Recruiting
San Antonio, Texas, United States, 78207
Contact: Site Public Contact 210-704-2894 bridget.medina@christushealth.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: Jose M. Esquilin
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: Matthew Dietz
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 CTOclinops@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: Sarah E. Leary
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 253-968-6144 Melissa.a.forouhar.mil@mail.mil
Principal Investigator: Melissa A. Forouhar
United States, West Virginia
West Virginia University Healthcare	Active, not recruiting
Morgantown, West Virginia, United States, 26506
United States, Wisconsin
University of Wisconsin Carbone Cancer Center	Recruiting
Madison, Wisconsin, United States, 53792
Contact: Site Public Contact 800-622-8922
Principal Investigator: Kenneth B. De Santes
Marshfield Medical Center-Marshfield	Recruiting
Marshfield, Wisconsin, United States, 54449
Contact: Site Public Contact 800-782-8581 oncology.clinical.trials@marshfieldresearch.org
Principal Investigator: Michelle A. Manalang
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	Active, not recruiting
San Juan, Puerto Rico, 00912
University Pediatric Hospital	Recruiting
San Juan, Puerto Rico, 00926
Contact: Site Public Contact 787-474-0333
Principal Investigator: Maria E. Echevarria

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

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Principal Investigator:	Donald W Parsons	Children's Oncology Group

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Parsons DW, Janeway KA, Patton DR, Winter CL, Coffey B, Williams PM, Roy-Chowdhuri S, Tsongalis GJ, Routbort M, Ramirez NC, Saguilig L, Piao J, Alonzo TA, Berg SL, Fox E, Hawkins DS, Abrams JS, Mooney M, Takebe N, Tricoli JV, Seibel NL; NCI-COG Pediatric MATCH Team. Actionable Tumor Alterations and Treatment Protocol Enrollment of Pediatric and Young Adult Patients With Refractory Cancers in the National Cancer Institute-Children's Oncology Group Pediatric MATCH Trial. J Clin Oncol. 2022 Jul 10;40(20):2224-2234. doi: 10.1200/JCO.21.02838. Epub 2022 Mar 30.

Jain J, Sutton KS, Hong AL. Progress Update in Pediatric Renal Tumors. Curr Oncol Rep. 2021 Feb 16;23(3):33. doi: 10.1007/s11912-021-01016-y.

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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:	June 5, 2023
Last Verified:	October 2022

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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 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	Neuroectodermal Tumors, Primitive, Peripheral Rhabdoid Tumor Nervous System Neoplasms Hepatoblastoma Central Nervous System Neoplasms Histiocytic Sarcoma Histiocytosis, Langerhans-Cell Histiocytosis Xanthogranuloma, Juvenile Recurrence Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases

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