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Individualized Treatment for Medulloblastoma (PNOC027 Trial)

N/A

Recruiting

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

Participants must have surgically accessible disease

Participants must have recurrent medulloblastoma

Must not have

Uncontrolled intercurrent illness including ongoing or active infection

Women of childbearing potential must not be pregnant or breast-feeding

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new way to treat medulloblastoma that is based on the molecular characteristics of each person's tumor.

Who is the study for?

This trial is for children and young adults aged 12 months to 39 years with recurrent medulloblastoma, a type of brain tumor. They must have tumors that can be surgically removed, be recovering from previous treatments, and have a certain level of physical ability. Pregnant or breastfeeding women are excluded, as well as those with other cancers or serious illnesses.

What is being tested?

The study tests an individualized treatment plan based on the molecular profile of each patient's tumor. It involves real-time drug screening and genomic sequencing to assign targeted therapies aimed at being effective yet less toxic.

What are the potential side effects?

Since this trial uses various treatments tailored to individuals' tumors, side effects will vary widely but may include typical reactions related to chemotherapy or targeted therapy such as nausea, fatigue, hair loss, blood count changes, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

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

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My disease can be operated on.

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My medulloblastoma has come back.

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I meet the specific radiation requirements.

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I am between 1 year and 39 years old.

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I am eligible for surgery or a biopsy.

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I am mostly independent and can do most activities.

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 uncontrolled illnesses or active infections.

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I am not pregnant or breastfeeding.

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I am currently on a treatment specifically targeting my cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Median Time from tissue collection to issued treatment plan from the specialized tumor board

Secondary study objectives

Proportion of participants with Adverse Events

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Individualized Treatment RecommendationExperimental Treatment1 Intervention

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.

0 / 9Eligibility criteria met