Larotrectinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With NTRK Fusions (A Pediatric MATCH Treatment Trial)

Summary

This phase II Pediatric MATCH trial studies how well larotrectinib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with NTRK fusions that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and have come back (relapased) or does not respond to treatment (refractory). Larotrectinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Conditions

• Advanced Malignant Solid Neoplasm
• Recurrent Ependymoma
• Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
• Recurrent Glioma
• Recurrent Hepatoblastoma
• Recurrent Kidney Wilms Tumor
• Recurrent Langerhans Cell Histiocytosis
• Recurrent Malignant Germ Cell Tumor
• Recurrent Malignant Glioma
• Recurrent Malignant Solid Neoplasm
• Recurrent Medulloblastoma
• Recurrent Neuroblastoma
• Recurrent Non-Hodgkin Lymphoma
• Recurrent Osteosarcoma
• Recurrent Rhabdoid Tumor
• Recurrent Rhabdomyosarcoma
• Recurrent Soft Tissue Sarcoma
• Refractory Ependymoma
• Refractory Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
• Refractory Glioma
• Refractory Hepatoblastoma
• Refractory Langerhans Cell Histiocytosis
• Refractory Malignant Germ Cell Tumor
• Refractory Malignant Glioma
• Refractory Malignant Solid Neoplasm
• Refractory Medulloblastoma
• Refractory Neuroblastoma
• Refractory Non-Hodgkin Lymphoma
• Refractory Osteosarcoma
• Refractory Primary Central Nervous System Neoplasm
• Refractory Rhabdoid Tumor
• Refractory Rhabdomyosarcoma
• Refractory Soft Tissue Sarcoma

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Bone Marrow Aspiration and Biopsy

Undergo a bone marrow aspiration and/or biopsy

PROCEDURE

Bone Scan

Undergo a bone scan

PROCEDURE

Computed Tomography

Undergo a CT scan

DRUG

Larotrectinib Sulfate

Given PO or via nasogastric- or gastric-tube

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Radionuclide Imaging

Undergo a MIBG scintigraphy

PROCEDURE

X-Ray Imaging

Undergo an x-ray

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Katherine A Janeway · Children's Oncology Group

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

12 Months

Max Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-08-23

Primary Completion

2024-09-30

Completion

2026-10-08

FDA Drug

Yes

Countries

• United States
• Puerto Rico

Study Locations