Selpercatinib for the Treatment of Advanced Solid Tumors, Lymphomas, or Histiocytic Disorders With Activating RET Gene Alterations, a Pediatric MATCH Treatment Trial

Summary

This phase II pediatric MATCH treatment trial studies how well selpercatinib works in treating patients with solid tumors that may have spread from where they first started to nearby tissue, lymph nodes, or distant parts of the body (advanced), lymphomas, or histiocytic disorders that have activating RET gene alterations. Selpercatinib may block the growth of cancer cells that have specific genetic changes in an important signaling pathway (called the RET pathway) and may reduce tumor size.

Conditions

• Hematopoietic and Lymphatic System Neoplasm
• Recurrent Ependymoma
• Recurrent Ewing Sarcoma
• Recurrent Hepatoblastoma
• Recurrent Histiocytic and Dendritic Cell Neoplasm
• Recurrent Langerhans Cell Histiocytosis
• Recurrent Lymphoma
• Recurrent Malignant Germ Cell Tumor
• Recurrent Malignant Glioma
• Recurrent Malignant Solid Neoplasm
• Recurrent Medulloblastoma
• Recurrent Neuroblastoma
• Recurrent Non-Hodgkin Lymphoma
• Recurrent Osteosarcoma
• Recurrent Peripheral Primitive Neuroectodermal Tumor
• Recurrent Rhabdoid Tumor
• Recurrent Rhabdomyosarcoma
• Recurrent Soft Tissue Sarcoma
• Recurrent WHO Grade 2 Glioma
• Refractory Ependymoma
• Refractory Ewing Sarcoma
• Refractory Hepatoblastoma
• Refractory Histiocytic and Dendritic Cell Neoplasm
• Refractory Langerhans Cell Histiocytosis
• Refractory Lymphoma
• Refractory Malignant Germ Cell Tumor
• Refractory Malignant Glioma
• Refractory Malignant Solid Neoplasm
• Refractory Medulloblastoma
• Refractory Neuroblastoma
• Refractory Non-Hodgkin Lymphoma
• Refractory Osteosarcoma
• Refractory Peripheral Primitive Neuroectodermal Tumor
• Refractory Rhabdoid Tumor
• Refractory Rhabdomyosarcoma
• Refractory Soft Tissue Sarcoma
• Refractory WHO Grade 2 Glioma
• Wilms Tumor

Interventions

PROCEDURE

Computed Tomography

Undergo CT, PET/CT, and/or CT/MRI

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI, PET/MRI, and/or CT/MRI

PROCEDURE

Positron Emission Tomography

Undergo PET, PET/CT, and/or PET/MRI

PROCEDURE

Radionuclide Imaging

Undergo scintigraphy

DRUG

Selpercatinib

Given PO

PROCEDURE

X-Ray Imaging

Undergo x-ray imaging

Sponsors & Collaborators

• Children's Oncology Group

  collaborator NETWORK

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Andrea T Franson · 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

2021-05-03

Primary Completion

2024-09-30

Completion

2026-06-30

FDA Drug

Yes

Countries

• United States
• Australia
• Puerto Rico

Study Locations