Study on Genetic Testing-Directed Targeted Therapy for Children with Relapsed or Hard-to-Treat Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03155620

Provider View

This clinical trial is exploring how well treatments guided by genetic testing work for children with advanced solid tumors, non-Hodgkin lymphomas, or histiocytic disorders that have not responded to standard treatments. The study uses genetic tests to identify specific mutations in the tumor cells, which may help doctors choose more effective treatments.

Patient Parameters

Program Overview

The Pediatric MATCH trial is investigating whether treatments based on genetic testing can help children with advanced solid tumors, non-Hodgkin lymphomas, or histiocytic disorders that have not improved with standard treatments. By examining the unique genetic makeup of a child's tumor, doctors can identify specific mutations that might respond better to targeted therapies. This approach aims to improve treatment outcomes and provide more personalized care for young patients.

Description

The main goal of this study is to use genetic and clinical data to find suitable treatments for children with advanced cancers. The study will determine how many children have tumors with genetic changes that can be targeted by specific drugs. It will also measure how well these treatments work in shrinking tumors.

Secondary goals include estimating how long children can live without their cancer getting worse while on these treatments, understanding how well children tolerate these therapies, and learning more about how the drugs behave in the body.

Exploratory goals aim to expand knowledge about the genetic landscape of advanced pediatric cancers, track genetic changes from diagnosis to relapse, and explore new ways to diagnose and profile these cancers using blood samples.

The study is conducted in two steps:

Step 1 (Screening): Children undergo a biopsy to test their tumor for specific genetic mutations. Blood samples are also collected for research.

Step 2 (Treatment): Children with identified mutations are assigned to one of several treatment groups, each targeting specific genetic changes with different investigational drugs. Treatment cycles repeat every 28 days for up to two years, as long as the cancer does not progress and side effects are manageable.

After completing the study treatment, children will have regular follow-ups to monitor their health and any long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Children aged 12 months to 21 years.
  • Have relapsed or hard-to-treat solid tumors, non-Hodgkin lymphomas, or histiocytic disorders.
  • Must have a tumor sample available for genetic testing.
  • Must have measurable disease based on recent imaging tests.
  • Must be in good overall health, with a performance status score of at least 50%.
  • Must have recovered from any previous cancer treatments.
  • Must have adequate blood counts and organ function.
  • Must be able to swallow pills or capsules, unless otherwise specified.

Exclusion Criteria

  • Pregnant or breastfeeding women cannot participate.
  • Cannot be taking certain medications, including corticosteroids, investigational drugs, or anti-cancer agents, unless specified.
  • Cannot have an uncontrolled infection.
  • Cannot have had a prior solid organ transplant.
  • Additional criteria may apply based on specific treatment groups.

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