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

Recruiting now · Not applicable

Conditions studied: Medulloblastoma, Medulloblastoma, Childhood, Medulloblastoma Recurrent, Ependymoma, Ependymoma Malignant, Ependymoma of Brain

In brief

The current study will use a new treatment approach based on the molecular characteristics of each participant's tumor. The study will test the feasibility in the pilot phase of performing real-time drug screening on tissue taken during surgery in patients with relapsed medulloblastoma or ependymoma and of having a specialized tumor board assign a treatment plan based on the results of this screening and genomic sequencing. The aim of this trial is to allow every child and young adult with relapsed medulloblastoma and ependymoma to receive the most effective and least toxic therapies currently available and will pave the way for improved understanding and treatment of these tumors in the future. Moreover, if successful, it could serve as a paradigm for personalized medicine programs for other types of cancer.

Key facts

Study ID

NCT05057702

Run by

University of California, San Francisco

People needed

74

Starts

2022-02-22

Expected to finish

2028-01-31

Last updated by the study team

2026-04-15

Who can join

Age: 1 and older, up to 39. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• The participant must have received at least one prior therapy at the time of initial diagnosis.
• Relapsed medulloblastoma or relapsed ependymoma are eligible.
• 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.
• Radiation - Participants must have:
• Had their last fraction of local irradiation to primary tumor >= 12 weeks prior to registration.
• Had their last fraction of craniospinal irradiation or total body irradiation >= 12 weeks prior to registration
• At least 14 days after local palliative radiation (small-port)
• Age >=12 months to <= 39 years of age.
• Karnofsky >= 50 for participants > 16 years of age and Lansky >= 50 for participants <= 16 years of age. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
• Corticosteroids: Participants who are receiving dexamethasone or equivalent must be on a stable or decreasing dose for at least 1 week prior to registration.
• Organ Function Requirements (within 7 days prior to study registration)
• Adequate Bone Marrow Function Defined as:
• 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.
• 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:

You may not qualify if…

• 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.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection.
• Women of childbearing potential must not be pregnant or breast-feeding. A negative serum or urine pregnancy test is required prior to start of therapy.
• Participants must not receive any tumor-directed therapy after enrollment, except for surgical resection/ biopsy.
• Important note: The eligibility criteria listed above are interpreted literally and cannot be waived.

Where it is running

• Children's Hospital of Los Angeles — Los Angeles, California, United States (enrolling)
• Rady Children's Hospital — San Diego, California, United States (enrolling)
• University of California, San Francisco — San Francisco, California, United States (enrolling)
• Children's National Hospital — Washington D.C., District of Columbia, United States (enrolling)
• St. Louis Children's Hospital / Washington University in St. Louis — St Louis, Missouri, United States (enrolling)
• New York University — New York, New York, United States (enrolling)
• Columbia University Medical Center — New York, New York, United States (enrolling)
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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