Ensartinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With ALK or ROS1 Genomic Alterations (A Pediatric MATCH Treatment Trial)

Summary

This phase II Pediatric MATCH treatment trial studies how well ensartinib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with ALK or ROS1 genomic alterations that have come back (recurrent) or does not respond to treatment (refractory) and may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Ensartinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Conditions

• Advanced Malignant Solid Neoplasm
• Malignant Solid Neoplasm
• Recurrent Ependymoma
• Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
• Recurrent Hepatoblastoma
• 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 Primary Central Nervous System Neoplasm
• Recurrent Rhabdoid Tumor
• Recurrent Rhabdomyosarcoma
• Recurrent Soft Tissue Sarcoma
• Refractory Ependymoma
• Refractory Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
• 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
• Wilms Tumor

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

Ensartinib

Given PO

OTHER

Laboratory Biomarker Analysis

Correlative studies

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

OTHER

Pharmacological Study

Correlative studies

PROCEDURE

Positron Emission Tomography

Undergo a PET scan

PROCEDURE

Radionuclide Imaging

Undergo radionuclide imaging

PROCEDURE

X-Ray Imaging

Undergo an x-ray

Sponsors & Collaborators

• Children's Oncology Group

  collaborator NETWORK

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Meredith S Irwin · 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

2018-04-17

Primary Completion

2025-09-30

Completion

2026-10-03

FDA Drug

Yes

Countries

• United States
• Australia
• Canada
• Puerto Rico

Study Locations