Molecular Profiling for Brain Tumor (PNOC008 Trial)

Recruiting in Palo Alto (17 mi)

+11 other locations

Overseen BySabine Mueller, MD, PhD, MAS

Age: < 65

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of California, San Francisco

No Placebo Group

Trial Summary

What is the purpose of this trial?This is a 2 strata pilot trial within the Pacific Pediatric Neuro-Oncology Consortium (PNOC). The study will use a new treatment approach based on each patient's tumor gene expression, whole-exome sequencing (WES), targeted panel profile (UCSF 500 gene panel), and RNA-Seq. The current study will test the efficacy of such an approach in children with High-grade gliomas HGG.

Eligibility Criteria

This trial is for children and young adults up to 21 years old with newly diagnosed high-grade gliomas (HGG), including those with specific genetic mutations but not DIPG. Participants must start radiation therapy within six weeks of diagnosis, have a certain level of physical function, and be able to give consent. Pregnant or breastfeeding individuals are excluded, as well as those on other clinical trials or with serious health issues that could affect participation.

Inclusion Criteria

I am 21 years old or younger.

I started radiation therapy less than 3 weeks ago.

Exclusion Criteria

I do not have any severe illnesses that could interfere with the study.

I am not pregnant or breastfeeding and have a negative pregnancy test.

Participant Groups

The trial tests an individualized treatment plan based on each patient's tumor genetics using gene expression profiling and sequencing techniques. The goal is to see if tailoring the treatment according to the tumor's molecular characteristics can improve outcomes in pediatric patients with HGG.

2Treatment groups

Experimental Treatment

Group I: Newly diagnosed HGG (Stratum A)Experimental Treatment1 Intervention

Children and young adults with newly diagnosed HGG receive an individualized treatment plan. Each treatment is different and depends on what the Specialized Tumor Board recommends depending on the molecular profile of the patient's tumor.

Group II: Diffuse midline HGG (Stratum B)Experimental Treatment1 Intervention

Children and young adults with diffuse midline high grade gliomas receive an individualized treatment plan. Each treatment is different and depends on what the Specialized Tumor Board recommends depending on the molecular profile of the patient's tumor.