Recruiting

PNOC027Genomic Testing for Personalized Treatment in Relapsed Medulloblastoma and Ependymoma

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Study Aim

This study aims to determine how genomic testing can guide personalized treatment plans for children and young adults with relapsed medulloblastoma and ependymoma, focusing on improving progression-free survival and ensuring timely treatment recommendations.

What is being tested

Specialized Tumor Board Treatment Plan

+ Combinations

Other
Who is being recruted

Ependymoma+8

+ Glioma

+ Medulloblastoma

From 12 Months to 39 Years
+20 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other Study

Interventional
Study Start: February 2022
See protocol details

Summary

Principal SponsorUniversity of California, San Francisco
Study ContactPNOC Operation Office
Last updated: March 17, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 22, 2022

Actual date on which the first participant was enrolled.

This study is focused on creating personalized treatment plans for children and young adults who have experienced a relapse of two types of brain tumors: medulloblastoma and ependymoma. By using advanced techniques like drug screening and genetic testing, researchers aim to tailor a treatment plan that uses up to four existing FDA-approved drugs for each participant. The main goal is to see if these personalized plans can improve survival rates and safety compared to traditional treatments. This approach is important as it could lead to more effective and less harmful treatments for these patients, offering hope for better management of their conditions. Participants in the study will have tissue samples taken from their tumors, which are then analyzed using drug screening and genetic sequencing. Based on this analysis, a specialized team recommends a treatment plan tailored to the individual. Participants may continue this treatment for up to two years, or longer if it is beneficial. The study measures how long participants live without their disease progressing, as well as their overall survival. Safety and potential side effects are also closely monitored to ensure treatments are well-tolerated. The results could lead to more precise and effective therapies for relapsed brain tumors in young patients.

Official TitleA Pilot Feasibility and Efficacy (Phase 2) Trial of Real Time Drug Screening and Genomic Testing to Determine an Individualized Treatment Plan in Children and Young Adults With Relapsed Medulloblastoma and Ependymoma
NCT05057702
Principal SponsorUniversity of California, San Francisco
Study ContactPNOC Operation Office
Last updated: March 17, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

74 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 12 Months to 39 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

EpendymomaGliomaMedulloblastomaNeoplasmsNeoplasms by Histologic TypeNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNeuroectodermal TumorsNeuroectodermal Tumors, PrimitiveNeoplasms, Neuroepithelial

Criteria

13 inclusion criteria required to participate
Participants must have recurrent medulloblastoma or recurrent ependymoma previously histologically confirmed. Participants must be experiencing their first or second relapse to be eligible.
Participants must have surgically accessible disease.
Prior Therapy: 1. The participant must have received at least one prior therapy at the time of initial diagnosis. 2. Relapsed medulloblastoma or relapsed ependymoma are eligible. 3. Participants must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study and would be eligible for surgical resection per institutional guidelines * Participants must have received last chemotherapy or biologic agent at least 7 days prior to registration. * Monoclonal antibody treatment: \> 21 days prior to registration. * Bevacizumab participants must have received last dose \> 21 days prior to study registration
Participant must be a candidate for surgical resection or biopsy with anticipated ability to obtain the minimum tissue requirements for study.
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7 exclusion criteria prevent from participating
Participants who have had chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
Participants who are receiving any other investigational agents.
Participants must be at least 7 days since the completion of therapy with a biologic or small molecule agent. For any agent with known adverse events that can occur beyond 7 days after administration, the period prior to enrollment must be beyond the time during which adverse events are known to occur. Such participants should also be discussed with study chairs.
Participants who are currently taking any anti-cancer direct therapy. Steroids are not considered anti-cancer therapy.
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants will receive an individualized treatment recommendation including a combination of up to four FDA-approved drugs within 21 business days of tissue acquisition using the results of real-time high-throughput drug screening, whole exome sequencing (WES), and RNA sequencing.

Group II

Experimental
Participants will receive an individualized treatment recommendation including a combination of up to four FDA-approved drugs within 21 business days of tissue acquisition using the results of real-time high-throughput drug screening, whole exome sequencing (WES), and RNA sequencing.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 8 locations

Recruiting

St. Louis Children's Hospital / Washington University in St. Louis

St Louis, United StatesOpen St. Louis Children's Hospital / Washington University in St. Louis in Google Maps
Recruiting

New York University

New York, United States
Recruiting

Columbia University Medical Center

New York, United States
Recruiting

Children's Hospital of Philadelphia

Philadelphia, United States
Recruiting
8 Study Centers