Samotolisib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With TSC or PI3K/MTOR Mutations (A Pediatric MATCH Treatment Trial)

Summary

This phase II Pediatric MATCH trial studies how well samotolisib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with TSC or PI3K/MTOR mutations that have spread to other places in the body (metastatic) and have come back (recurrent) or do not respond to treatment (refractory). Samotolisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Conditions

• Advanced Malignant Solid Neoplasm
• Ann Arbor Stage III Non-Hodgkin Lymphoma
• Ann Arbor Stage IV Non-Hodgkin Lymphoma
• Malignant Glioma
• 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 Rhabdomyosarcoma
• Recurrent Soft Tissue Sarcoma
• Refractory Langerhans Cell Histiocytosis
• Refractory Malignant Germ Cell Tumor
• Refractory Malignant Solid Neoplasm
• Refractory Neuroblastoma
• Refractory Non-Hodgkin Lymphoma
• Refractory Primary Central Nervous System Neoplasm
• 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

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood specimen collection

PROCEDURE

Computed Tomography

Undergo CT

PROCEDURE

FDG-Positron Emission Tomography

Undergo FDG-PET

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

DRUG

Samotolisib

Given PO

PROCEDURE

X-Ray Imaging

Undergo x-ray

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Theodore W Laetsch · 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

2017-11-28

Primary Completion

2023-09-30

Completion

2024-12-31

FDA Drug

Yes

Countries

• United States
• Puerto Rico

Study Locations