Entrectinib for Treating Young Children with Specific Brain Tumors

Sponsor: St. Jude Children's Research Hospital

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06528691

Provider View

This clinical trial is testing how well the drug entrectinib works for children under 3 years old who have certain types of brain tumors with specific genetic changes. The study aims to see if this treatment can help control the tumors and improve survival rates.

Patient Parameters

Program Overview

The purpose of this study is to find out if entrectinib, a medication, can effectively treat young children under 3 years old with brain tumors that have specific genetic changes called NTRK1/2/3 or ROS1 fusions. The study will look at how well the tumors respond to the treatment and how long the children can live without the cancer getting worse. It will also examine the safety of the drug and whether it can help make surgery more successful if needed.

Description

This study is focused on using entrectinib as the first treatment for young children with specific types of brain tumors. The main goal is to see how well the tumors respond to the drug. Researchers will also look at how long the children live without the cancer getting worse and how long the treatment effects last. They will also check if the drug helps make surgery more successful and if it is safe for the children.

The study has two groups:

  • Cohort 1: Children with high-grade glioma (HGG) with NTRK1/2/3 or ROS1 fusions.
  • Cohort 2: Children with other types of brain tumors with NTRK1/2/3 or ROS1 fusions.

Children will take entrectinib by mouth once a day in 28-day cycles, up to 24 cycles, unless the cancer worsens or side effects are too severe. If needed, they may receive other medications before starting entrectinib. If the drug helps shrink the tumor, surgery might be possible, and the treatment will continue for a total of 24 cycles.

After finishing the treatment, children will be monitored for 5 years to check their health and any long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Children under 3 years old at diagnosis.
  • Newly diagnosed brain tumor in a specific area of the brain.
  • Tumor must be measurable by specific criteria.
  • Surgery or biopsy done within the last 42 days.
  • Tumor tissue available for review.
  • Parent or guardian must understand and agree to the study by signing a consent form.

Exclusion Criteria

  • Previous chemotherapy or radiation treatment.

For Cohort 1:

  • High-grade glioma with specific genetic changes.
  • No prior cancer treatments.
  • Good overall health and life expectancy of at least 12 weeks.
  • Stable neurological condition for at least 7 days before joining the study.
  • Sufficient blood counts and organ function.
  • Ability to follow the treatment plan and attend study visits.

For Cohort 2:

  • Other brain tumors with specific genetic changes.
  • No prior cancer treatments.
  • Good overall health and life expectancy of at least 12 weeks.
  • Stable neurological condition for at least 7 days before joining the study.
  • Sufficient blood counts and organ function.
  • Ability to follow the treatment plan and attend study visits.

For Both Cohorts:

  • No serious medical conditions that could affect the study.
  • No recent heart failure or uncontrolled infections.
  • Not taking certain epilepsy medications.
  • No other cancer treatments or investigational drugs.
  • No recent surgery or known allergies to the study drug.
  • No digestive issues that affect drug absorption.
  • Must be able to take medication by mouth.

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