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

Summary

This phase II Pediatric MATCH trial studies how well erdafitinib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with FGFR mutations that have spread to other places in the body and have come back or do not respond to treatment. Erdafitinib may stop the growth of cancer cells with FGFR mutations by blocking some of the enzymes needed for cell growth.

Conditions

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

Erdafitinib

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

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Alice Lee · 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

2018-06-05

Primary Completion

2023-09-30

Completion

2026-12-30

FDA Drug

Yes

Countries

• United States
• Puerto Rico

Study Locations