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Molecular Profiling

Molecular Profiling for Brain Tumor (PNOC008 Trial)

N/A

Waitlist Available

Led By Sabine Mueller, MD, PhD, MAS

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≤ 21 years

Enrollment within 3 weeks of the start of radiation therapy.

Must not have

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Female patients of childbearing potential must not be pregnant or breast-feeding. Female patients of childbearing potential must have a negative serum or urine pregnancy test prior to the start of therapy (as clinically indicated).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new treatment approach for children with High-grade gliomas HGG that is based on each patient's tumor gene expression, whole-exome sequencing (WES), targeted panel profile (UCSF 500 gene panel), and RNA-Seq.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves creating personalized treatment plans based on molecular profiling rather than testing a specific drug, side effects will vary depending on the treatments chosen for each participant. However, potential side effects may include typical cancer therapy-related reactions such as nausea, fatigue, hair loss, increased risk of infection, and others.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 21 years old or younger.

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I started radiation therapy less than 3 weeks ago.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

12 month Overall Survival (OS) for Stratum B

12 month Progression Free Survival (PFS) for Stratum A

Secondary study objectives

Frequency of Adverse Events

Frequency of Serious Adverse Events

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 4Eligibility criteria met