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Individualized Treatment for Relapsed Medulloblastoma and Ependymoma

This study is for children and young adults (ages 1 to 39) with medulloblastoma or ependymoma that has come back (relapsed). It aims to create a personalized treatment plan for each participant. Doctors will analyze a sample of your tumor taken during surgery. This analysis will help them recommend up to four FDA-approved drugs that might work best for you. The goal is to find the most effective and least harmful treatments. The study is currently focused on determining if these personalized treatment plans can be developed quickly enough to be useful. The study is also looking at how safe these treatments are and how well they prevent the cancer from growing.

Study design
This is an interventional study that plans to enroll 74 participants. It is a multi-center pilot trial within the Pacific Pediatric Neuro-Oncology Consortium (PNOC).
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05057702

Individualized Treatment Plan in Children and Young Adults With Relapsed Medulloblastoma and Ependymoma

Recruiting
NAAges 12–39Interventional
University of California, San Francisco
~74 participants
Updated 2026-08-11 on ClinicalTrials.gov
What's tested:Specialized Tumor Board Treatment PlanCombinations

At a glance

Recruiting sites
9 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants for whom treatment recommendations are fully completed within 21 business days of tissue collection based on drug screening (Pilot Phase)
Measured over Up to 21 days
+4 more outcomes measured

Conditions

Medulloblastoma
Medulloblastoma, Childhood
Medulloblastoma Recurrent
Ependymoma
Ependymoma Malignant
Ependymoma of Brain

Explore related trials

EpendymomaMedulloblastoma

Where it's being run

9 sites across 6 states
California3
New York2
District of Columbia1
Minnesota1
Missouri1
Pennsylvania1

Study leadership

  • Sabine Mueller, MD, PhD, MAS · PRINCIPAL_INVESTIGATOR · University of California, San Francisco
  • Robert Wechsler-Reya, PhD · STUDY_CHAIR · Columbia University
  • Margaret Shatara, MD · STUDY_CHAIR · Children's Minnesota
  • Megan Paul, MD · STUDY_CHAIR · Rady Children's Hospital, San Diego
  • Lindsay Kilburn, MD · STUDY_CHAIR · Children's National Research Institute

Who to contact

PNOC Operation Office
[email protected]
415-502-1600
Email the study team

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Eligibility criteria

Inclusion

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 4. Participant must be a candidate for surgical resection or biopsy with anticipated ability to obtain the minimum tissue requirements for study. 5. Radiation - Participants must have:
Peripheral absolute neutrophil count (ANC) \>= 750/mm\^3
Platelet count \>= 75,000/mm\^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment).
Hemoglobin \>= 8 g/dl. 2. Adequate Renal Function Defined as:
Creatinine clearance or radioisotope GFR \>= 70 milliliter/minute (mL/min) /1.73 m\^2 or
A serum creatinine based on age/sex as follows:
1 to \< 2 years / 0.6 / 0.6.
2 to \< 6 years / 0.8 / 0.8.
6 to \< 10 years / 1 / 1.
10 to \< 13 years / 1.2 / 1.2.
13 to \< 16 years / 1.5 / 1.4.
\>= 16 years / 1.7 / 1.4.
\- The threshold creatinine values in this table were derived from the Schwartz formula for estimating Glomerular filtration rate (GFR) utilizing child length and stature data published by the Center for Disease Control (CDC) (Schwartz GJ and Gauthier B 1985). 3. Adequate Liver Function Defined as:
Total Bilirubin \<= 1.5 x upper limit of normal (ULN) for age; in presence of Gilbert's syndrome, total bilirubin \< 3 x ULN or direct bilirubin \< 1.5 x ULN.
Alanine aminotransferase (ALT) \<= 3x ULN.
Aspartate aminotransferase (AST) \<= 3x ULN. 10. The effects of the agents used in this study on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and 4 months after completion of therapy administration. Should a woman become pregnant or suspect pregnancy while participating in this study, the treating physician should be informed immediately. 11. Adequate neurologic function defined as participants with seizure disorder may be enrolled if seizures are well controlled. Participants on non-enzyme inducing anticonvulsants may be excluded pending interaction(s) with study drug. 12. Participants must enroll on the Protocol for Children and Young Adults Diagnosed with a Central Nervous System (CNS) Tumor to Assess Cognitive, Quality of Life (QOL), and Comprehensive Effects of Therapies (PNOC COMP) study if PNOC COMP is open to accrual at the enrolling institution 13. A legal parent/guardian or participant must be able to understand, and willing to sign, a written informed consent and assent document, as appropriate.

What this trial measures

  • Number of participants for whom treatment recommendations are fully completed within 21 business days of tissue collection based on drug screening (Pilot Phase)Up to 21 days

    Time to tissue collection will be used to determine the feasibility of using the results of real-time in vitro drug screening, WES and RNAseq of participant-derived specimens to guide treatment recommendations by a specialized tumor board, in a clinically-actionable timeframe, for children and young adults with recurrent medulloblastoma. Participants are expected to receive treatment plan within 21 business days

  • Percentage of participants with treatment recommendations within 21 business days (Pilot Phase)Up to 21 days

    Time to tissue collection will be used to determine the feasibility of using the results of real-time in vitro drug screening, WES and RNAseq of participant-derived specimens to guide treatment recommendations by a specialized tumor board, in a clinically-actionable timeframe, for children and young adults with recurrent medulloblastoma. Participants are expected to receive treatment plan within 21 business days

  • Number of participants without adequate tissueUp to 21 days

    The number of consented participants who do not have adequate tissue collection will be used to determine the feasibility.

  • Median Time from tissue collection to issued treatment plan from the specialized tumor board (Pilot Phase)Up to 21 days

    Time to tissue collection will be used to determine the feasibility of using the results of real-time in vitro drug screening, WES and RNAseq of participant-derived specimens to guide treatment recommendations by a specialized tumor board, in a clinically-actionable timeframe, for children and young adults with recurrent medulloblastoma. Participants are expected to receive treatment plan within 21 business days

  • Median Progression-free survival (PFS) (Efficacy Phase)Up to 5 years

    The median months from the time of surgery for this recurrence to the first evidence of progression or death, using PFS at 10 months (PFS10) for the relapsed medulloblastoma cohort and PFS at 17 months for the relapsed ependymoma cohort (Arm B).