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Alkylating agents

Reduced Radiation + Chemotherapy for Medulloblastoma

Phase 2

Waitlist Available

Led By Nicholas J Gottardo

Research Sponsored by Children's Oncology Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

6 to < 10 years of age: max serum creatinine 1 mg/dL (males and females)

Patients must be newly diagnosed and have: Eligibility confirmed by rapid central pathology and molecular screening review on APEC14B1: Classical histologic type (non LC/A) WNT medulloblastoma Positive nuclear beta-catenin by immunohistochemistry (IHC) Positive for CTNNB1 mutation Negative for MYC and MYCN by fluorescence in situ hybridization (FISH)

Must not have

Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained

Female patients who are pregnant are ineligible due to risks of fetal and teratogenic adverse events as seen in animal/human studies

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing how well reduced doses of radiation therapy to the brain and spine, plus chemotherapy, work in treating patients with a certain type of brain tumor.

Who is the study for?

This trial is for young patients with a newly diagnosed brain tumor called WNT-driven medulloblastoma. Eligible participants must be between 3 and 22 years old, have good kidney and liver function, adequate blood counts, no prior tumor-directed therapy except surgery/corticosteroids, not pregnant or breastfeeding, agree to use contraception if applicable, and able to perform required language skills for assessments.

What is being tested?

The study tests whether lower doses of radiation therapy to the brain/spine along with chemotherapy (cisplatin, vincristine sulfate, cyclophosphamide and lomustine) are effective in treating WNT-driven medulloblastoma while reducing late side effects like learning difficulties or hormone deficiencies.

What are the potential side effects?

Potential side effects include those common to chemotherapy such as nausea, hair loss, increased risk of infection due to low blood cell counts; and from radiation therapy like fatigue and skin irritation. Long-term risks may involve cognitive impairment or growth development issues.

Eligibility Criteria

Inclusion Criteria

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

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I am between 6 and 10 years old with a creatinine level of 1 mg/dL or less.

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My medulloblastoma is WNT type, confirmed by specific tests.

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My cancer has a CTNNB1 mutation.

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My medulloblastoma is of the WNT type, not the LC/A type.

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My blood counts meet the required levels for neutrophils, platelets, and hemoglobin.

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My kidney function is within the required range for my age and gender.

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My bilirubin levels are normal and my liver enzyme (ALT) is below 135 U/L.

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My cancer shows positive for beta-catenin.

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My child is between 3 and 6 years old with a creatinine level of 0.8 mg/dL or less.

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I am between 10 and 13 years old with a creatinine level of no more than 1.2 mg/dL.

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My cancer does not have MYC or MYCN abnormalities.

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My kidney function is normal or near normal.

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I am 13-15 years old with a creatinine level below 1.5 (male) or 1.4 (female).

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I am over 16 and my kidney function tests are within the normal range.

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My bilirubin levels are within normal range for my age.

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My tumor is less than 1.5 cm^2, confirmed by a special imaging review.

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I am between 3 and 21 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am a woman able to have children and have a negative pregnancy test.

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I am not pregnant, as pregnancy could risk the trial's safety.

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I haven't had radiation or chemotherapy, only surgery or steroids.

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My cancer has not spread to my brain or spine, and I can undergo a lumbar puncture.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 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

Progression-free survival (PFS)

Secondary study objectives

Body Weight Changes

Deoxyribonucleic acid (DNA) methylation profiling as real-time classification of WNT-driven medulloblastoma

Other study objectives

Audiologic and endocrinologic toxicities

DNA methylation profiling of medulloblastoma real-time" predictive classification scheme for the SHH, group 3 and group 4 medulloblastoma subgroups according to the Heidelberg classifier

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: Treatment (reduced radiation therapy and chemotherapy)Experimental Treatment8 Interventions

RADIATION THERAPY: Beginning 4-5 weeks after surgery, patients undergo craniospinal radiation therapy 5 days a week for 6 weeks. MAINTENANCE THERAPY (WEEKS 1, 3, 5, and 7): Beginning 4-6 weeks after completion of radiation therapy patients receive lomustine PO on day 1, vincristine sulfate IV over 1 minute or via minibag on days 1, 8, and 15, and cisplatin IV over 6 hours on day 1. Treatment repeats every 42 days in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY (WEEKS 2, 4, AND 6): Patients receive cyclophosphamide IV over 30-60 minutes on days 1 and 2, mesna IV over 15-30 minutes on days 1 and 2, and vincristine sulfate IV over 1 minute or via minibag on days 1 and 8. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI throughout the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Magnetic Resonance Imaging

2017

Completed Phase 3

~1160

Cisplatin

2013

Completed Phase 3

~3120