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Platinum-based Chemotherapy

Chemotherapy + Radiation for Medulloblastoma

Phase 3
Waitlist Available
Led By Sarah E Leary
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
Newly diagnosed, previously untreated patients with specific criteria for medulloblastoma
Avoid selected strong inhibitors and inducers of cytochrome P450 3A4
Must not have
Patients with M4 disease not eligible
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial is testing different combinations of chemotherapy and radiation therapy to compare how well they work in treating patients with newly diagnosed, high-risk medulloblastoma.

Who is the study for?
This trial is for young patients with a high-risk type of brain tumor called medulloblastoma, who haven't been treated before. They should have normal liver and kidney function, no history of certain drug use that affects the liver enzyme CYP450 3A4, and acceptable blood counts. Pregnant or breastfeeding women can't join, and participants must agree to use birth control. Patients need to be able to perform daily activities at least minimally despite their illness.
What is being tested?
The study tests different combinations of chemotherapy drugs (vincristine sulfate, cisplatin, cyclophosphamide, carboplatin) and radiation therapy in treating medulloblastoma. It aims to find out which regimen is more effective against this brain tumor by comparing how well they stop the growth or spread of cancer cells.
What are the potential side effects?
Possible side effects include hair loss, nausea and vomiting from chemotherapy; hearing loss due to cisplatin; increased risk of infections because filgrastim stimulates white blood cell production; tiredness from isotretinoin treatment; skin changes from radiation therapy; and potential impact on quality-of-life.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been newly diagnosed with medulloblastoma and have not received any treatment.
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I am not taking strong drugs that affect liver enzymes.
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I have not had chemotherapy or radiation therapy before.
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I am not taking corticosteroids with my chemotherapy.
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My kidney function, measured by creatinine levels, is appropriate for my age and gender.
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I am not pregnant.
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I have had an MRI of my spine with a special dye.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer has not spread to distant organs (not M4).

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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
Percent Probability of Event-free Survival (EFS) for Patients With Medulloblastoma
Percent Probability of Event-free Survival (EFS) for Patients With Supratentorial Primitive Neuroectodermal Tumor (SPNET)
Secondary study objectives
Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) at 30+/-6 Months Post Diagnosis for Medulloblastoma Patients
Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) at 30+/-6 Months Post Diagnosis for SPNET Patients
Medulloblastoma
+13 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Arm D (chemoradiotherapy, isotretinoin-CLOSED TO ACCRUAL)Experimental Treatment8 Interventions
CHEMORADIOTHERAPY: Patients undergo chemoradiotherapy as in Arm B. Six weeks after completion of chemoradiotherapy, patients proceed to maintenance therapy. MAINTENANCE THERAPY: Patients receive maintenance therapy as in Arm C. Patients then proceed to continuation therapy. CONTINUATION THERAPY: Patients receive continuation therapy as in Arm C.
Group II: Arm C (chemoradiotherapy, isotretinoin-CLOSED TO ACCRUAL)Experimental Treatment7 Interventions
CHEMORADIOTHERAPY: Patients undergo chemoradiotherapy as in Arm A. Six weeks after completion of chemoradiotherapy, patients proceed to maintenance therapy. MAINTENANCE THERAPY: Patients receive isotretinoin PO BID on day 1 and days 16-28 and cisplatin, vincristine sulfate, cyclophosphamide, and filgrastim as in Arm A maintenance therapy. Treatment repeats every 28 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to continuation therapy. CONTINUATION THERAPY: Patients receive isotretinoin PO BID on days 15-28 every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Group III: Arm B (chemoradiotherapy)Experimental Treatment10 Interventions
CHEMORADIOTHERAPY: Patients receive vincristine sulfate and undergo radiation therapy as in Arm A. Patients also receive carboplatin IV over 15 minutes on each day of radiation therapy. Six weeks after completion of chemoradiotherapy, patients proceed to maintenance therapy. MAINTENANCE THERAPY: Patients receive maintenance therapy as in Arm A. Patients also undergo blood sample collection, lumbar puncture and MRI throughout the study.
Group IV: Arm A (chemoradiotherapy)Active Control9 Interventions
CHEMORADIOTHERAPY: Patients undergo radiation therapy QD five days a week for 6 weeks. Patients also receive vincristine sulfate IV over 1 minute once weekly for 6 weeks. Six weeks after completion of chemoradiotherapy, patients proceed to maintenance therapy. MAINTENANCE THERAPY: Patients receive cisplatin IV over 6 hours on day 1, vincristine sulfate IV over 1 minute on days 1 and 8, and cyclophosphamide IV over 1 hour on days 2 and 3. Patients also receive filgrastim SC or IV beginning on day 4 and continuing until blood counts recover (at least 10 days). Treatment repeats every 28 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection, lumbar puncture and MRI throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Filgrastim
2000
Completed Phase 3
~3690
Lumbar Puncture
2016
Completed Phase 3
~510
Biospecimen Collection
2004
Completed Phase 3
~2020
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Vincristine Sulfate
2005
Completed Phase 3
~10270
Isotretinoin
2019
Completed Phase 4
~3520
Radiation Therapy
2017
Completed Phase 3
~7250
Cyclophosphamide
2010
Completed Phase 4
~2320
Cisplatin
2013
Completed Phase 3
~3120
Carboplatin
2014
Completed Phase 3
~6120

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,868 Previous Clinical Trials
41,010,458 Total Patients Enrolled
89 Trials studying Medulloblastoma
9,962 Patients Enrolled for Medulloblastoma
Children's Oncology GroupLead Sponsor
457 Previous Clinical Trials
239,451 Total Patients Enrolled
17 Trials studying Medulloblastoma
3,381 Patients Enrolled for Medulloblastoma
Sarah E LearyPrincipal InvestigatorChildren's Oncology Group
1 Previous Clinical Trials
33 Total Patients Enrolled
1 Trials studying Medulloblastoma
33 Patients Enrolled for Medulloblastoma

Media Library

Medulloblastoma Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT00392327 — Phase 3
~21 spots leftby Oct 2025
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