Find-A-Study

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)

Purpose

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.

Study Contact

Principal Investigator
Anne-Marie Langevin

Virginia Diaz
210-562-9149
diazvr@uthscsa.edu

Jaclyn Hung
210-450-5358
hungj@uthscsa.edu

Eligibility

Eligible Ages: Between 12 Months and 21 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Exclusion Criteria

Study Design

Phase: Phase 2
Study Type: Interventional
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Screening
Masking: None (Open Label)
Condition: 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

Arm Groups

Arm	Description	Intervention
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: Biospecimen Collection Undergo collection of blood Drug: Larotrectinib Given PO or via nasogastric- or gastric-tube Other names: ARRY 470 LOXO 101 LOXO-101 Other: Pharmacological Study Correlative studies Procedure: Biopsy Undergo biopsy Other names: BIOPSY_TYPE Bx Other: Laboratory Biomarker Analysis Undergo molecular analysis Procedure: Mutation Carrier Screening Undergo tumor tissue mutation screening
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: Biospecimen Collection Undergo collection of blood Other: Pharmacological Study Correlative studies Drug: Tazemetostat Given PO Other names: E7438 EPZ-6438 EPZ6438 Procedure: Biopsy Undergo biopsy Other names: BIOPSY_TYPE Bx Other: Laboratory Biomarker Analysis Undergo molecular analysis Procedure: Mutation Carrier Screening Undergo tumor tissue mutation screening
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: Biospecimen Collection Undergo collection of blood Other: Pharmacological Study Correlative studies Procedure: Biopsy Undergo biopsy Other names: BIOPSY_TYPE Bx Other: Laboratory Biomarker Analysis Undergo molecular analysis Procedure: Mutation Carrier Screening Undergo tumor tissue mutation screening Drug: Selumetinib Sulfate Given PO Other names: AZD-6244 Hydrogen Sulfate AZD6244 Hydrogen Sulfate AZD6244 Hydrogen Sulphate Koselugo Selumetinib Sulphate
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: Biospecimen Collection Undergo collection of blood Other: Pharmacological Study Correlative studies Procedure: Biopsy Undergo biopsy Other names: BIOPSY_TYPE Bx Other: Laboratory Biomarker Analysis Undergo molecular analysis Procedure: Mutation Carrier Screening Undergo tumor tissue mutation screening 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 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: Biospecimen Collection Undergo collection of blood Other: Pharmacological Study Correlative studies Procedure: Biopsy Undergo biopsy Other names: BIOPSY_TYPE Bx 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
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: Biospecimen Collection Undergo collection of blood Other: Pharmacological Study Correlative studies Drug: Selpercatinib Given PO Other names: LOXO-292 RET Kinase Inhibitor LOXO-292 Retevmo WHO 10967 Procedure: Biopsy Undergo biopsy Other names: BIOPSY_TYPE Bx Other: Laboratory Biomarker Analysis Undergo molecular analysis Procedure: Mutation Carrier Screening Undergo tumor tissue mutation screening
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: Biospecimen Collection Undergo collection of blood Other: Pharmacological Study Correlative studies Procedure: Biopsy Undergo biopsy Other names: BIOPSY_TYPE Bx Other: Laboratory Biomarker Analysis Undergo molecular analysis Procedure: Mutation Carrier Screening Undergo tumor tissue mutation screening Drug: Tipifarnib Given PO or via nasogastric or gastric tube Other names: R115777 Zarnestra
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: Biospecimen Collection Undergo collection of blood Drug: Erdafitinib Given PO Other names: Balversa JNJ-42756493 Other: Pharmacological Study Correlative studies Procedure: Biopsy Undergo biopsy Other names: BIOPSY_TYPE Bx Other: Laboratory Biomarker Analysis Undergo molecular analysis Procedure: Mutation Carrier Screening Undergo tumor tissue mutation screening
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: Biospecimen Collection Undergo collection of blood Other: Pharmacological Study Correlative studies Procedure: Biopsy Undergo biopsy Other names: BIOPSY_TYPE Bx Other: Laboratory Biomarker Analysis Undergo molecular analysis Procedure: Mutation Carrier Screening Undergo tumor tissue mutation screening 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 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: Biospecimen Collection Undergo collection of blood Other: Pharmacological Study Correlative studies Procedure: Biopsy Undergo biopsy Other names: BIOPSY_TYPE Bx Drug: Ensartinib Given PO Other names: X-396 Other: Laboratory Biomarker Analysis Undergo molecular analysis Procedure: Mutation Carrier Screening Undergo tumor tissue mutation screening
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: Biospecimen Collection Undergo collection of blood Drug: Olaparib Given PO Other names: AZD 2281 AZD-2281 AZD2281 KU-0059436 Lynparza PARP Inhibitor AZD2281 Other: Pharmacological Study Correlative studies Procedure: Biopsy Undergo biopsy Other names: BIOPSY_TYPE Bx Other: Laboratory Biomarker Analysis Undergo molecular analysis Procedure: Mutation Carrier Screening Undergo tumor tissue mutation screening
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: Biospecimen Collection Undergo collection of blood Other: Pharmacological Study Correlative studies Drug: Ulixertinib Receive PO Other names: BVD-523 VRT752271 Procedure: Biopsy Undergo biopsy Other names: BIOPSY_TYPE Bx Other: Laboratory Biomarker Analysis Undergo molecular analysis Procedure: Mutation Carrier Screening Undergo tumor tissue mutation screening