Molecular Profiling for Brain Tumor
(PNOC008 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial focuses on developing personalized treatment plans for children and young adults with high-grade gliomas (HGG), a type of brain tumor. By examining the genetic makeup of each patient's tumor, the researchers aim to identify the most effective treatment method for each individual. Participants will receive a treatment plan tailored by a specialized tumor board (a group of medical experts) based on their tumor's genetic profile. This trial suits those newly diagnosed with high-grade gliomas who have begun radiation therapy within the past six weeks. As an unphased trial, it offers the opportunity to receive a highly personalized treatment approach that could significantly impact health.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot be on any anti-cancer therapy except for steroids and temozolomide during radiation therapy. It's best to discuss your specific medications with the study team.
What prior data suggests that this treatment approach is safe for children with high-grade gliomas?
Research has shown that recommendations from tumor boards are very effective. In one study, 91% of their treatment suggestions were followed. Tumor boards consist of experts who create personalized treatment plans based on the unique details of a patient's tumor. They don't rely on a single drug or treatment; instead, they develop a plan that may include various treatments, depending on the board's decisions.
As this is an early trial, specific safety data might be limited. However, guidance from a tumor board suggests that the plans are carefully considered, focusing on the safest options for each patient. Without specific treatment data, predicting how well each plan will be tolerated is challenging. Nonetheless, the expertise of the tumor board indicates that safety is a priority.12345Why are researchers excited about this trial?
Unlike standard treatments for high-grade gliomas, which often involve surgery, radiation, and chemotherapy, the study treatment is unique because it tailors therapy based on the molecular profile of each patient's tumor. This personalized approach means that the Specialized Tumor Board recommends treatments specifically targeting the genetic characteristics of the tumor, potentially leading to more effective outcomes. Researchers are excited about this method because it allows for a customized plan that could improve response rates and potentially reduce side effects, offering hope for better management of these aggressive brain tumors in children and young adults.
What evidence suggests that this trial's treatments could be effective for high-grade gliomas?
Research has shown that diffuse midline gliomas (DMG), a type of aggressive brain tumor, are difficult to treat with standard methods like radiation and chemotherapy. In this trial, children and young adults with DMG will receive individualized treatment plans based on the molecular profile of their tumors, as recommended by the Specialized Tumor Board. A new drug, dordaviprone, has shown promise for DMG, with about 22% of patients responding to it and an average response lasting 10.3 months. This drug targets the genetic changes in DMG, offering new hope for those affected.
For newly diagnosed high-grade gliomas (HGG), participants will also receive personalized treatment plans. Treatments like tumor treating fields (TTFields) have been found to help patients live longer without the disease worsening and to improve overall survival. Recent studies indicate that about 36% of patients live for five years, which marks a significant improvement given the serious nature of these brain tumors. These advancements suggest that personalized treatment plans based on the tumor's genetic makeup could lead to better outcomes for children with these conditions.678910Who Is on the Research Team?
Sabine Mueller, MD, PhD, MAS
Principal Investigator
University of California, San Francisco
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive an individualized treatment plan based on molecular profiling of their tumor
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Specialized tumor board recommendation
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Francisco
Lead Sponsor
The V Foundation for Cancer Research
Collaborator
Pacific Pediatric Neuro-Oncology Consortium
Collaborator