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Platinum-based Chemotherapy

Chemotherapy + Radiation for Medulloblastoma

Phase 3
Waitlist Available
Led By James M Olson
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Arm D (chemoradiotherapy, isotretinoin-CLOSED TO ACCRUAL)Experimental Treatment9 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 Treatment8 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 Treatment8 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.
Group IV: Arm A (chemoradiotherapy)Active Control7 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Filgrastim
2000
Completed Phase 3
~3670
Vincristine Sulfate
2005
Completed Phase 3
~10120
Isotretinoin
2019
Completed Phase 4
~3520
Radiation Therapy
2017
Completed Phase 3
~7250
Cyclophosphamide
1995
Completed Phase 3
~3780
Cisplatin
2013
Completed Phase 3
~1940
Carboplatin
2014
Completed Phase 3
~6670

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,606 Previous Clinical Trials
40,913,105 Total Patients Enrolled
86 Trials studying Medulloblastoma
9,639 Patients Enrolled for Medulloblastoma
Children's Oncology GroupLead Sponsor
453 Previous Clinical Trials
237,021 Total Patients Enrolled
17 Trials studying Medulloblastoma
3,381 Patients Enrolled for Medulloblastoma
James M OlsonPrincipal InvestigatorChildren's Oncology Group

Media Library

Medulloblastoma Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT00392327 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there many places in Canada where this trial is taking place?

"Currently, this clinical trial is based in Children's Hospital of Alabama, University of Alabama at Birmingham Cancer Center, Providence Alaska Medical Center, and 100 other locations."

Answered by AI

Are adults within the age range of 20-25 years eligible for this research opportunity?

"477 other clinical trials focus on children under 18 whereas this study is seeking applicants that are between the ages of 3 and 21. In contrast, there are 1818 medical trials for adults over the age of 65."

Answered by AI

What are we trying to learn by conducting this clinical trial?

"The primary outcome of this clinical trial, which will be evaluated over approximately Up to 5 years is to Percent Probability of Event-free Survival (EFS) for Patients With Supratentorial Primitive Neuroectodermal Tumor (SPNET). Secondary outcomes include Metacognition Index (MI) on the Behavior Rating Inventory of Executive Function (BRIEF) at 60+/-12 Months Post Diagnosis for SPNET Patients which is defined as Metacognition index (MI) was measured by BRIEF test. Assessments within the time window, from eligible and evaluable patients are reported. If the"

Answered by AI

What are some of the most common maladies that Cisplatin has been shown to improve?

"Cisplatin is often used as a first-line treatment, but it is also effective in treating small cell lung cancer, advanced testicular cancer, and other lung cancers."

Answered by AI

Has Cisplatin been looked at before in other research?

"Cisplatin was first trialled in 1997 at City of Hope Comprehensive Cancer Center. Out of the 3697 completed clinical trials, 2103 are still recruiting patients. The great majority of these trials are being conducted in Birmingham, Alabama."

Answered by AI

Do you have any information about whether this research is still looking for participants?

"This research is not currently recruiting patients. The first posting was on March 26th, 2007, with the most recent update on January 4th, 20212. If you are looking for other studies, there are presently 76 studies actively searching for patients with medulloblastoma and 2103 trials for Cisplatin actively admitting patients."

Answered by AI

Has Cisplatin been approved by the FDA for medication use?

"Cisplatin is considered safe, with a score of 3, because it has been through multiple rounds of testing and there is some data supporting its efficacy."

Answered by AI

Are there any specific medical requirements for this clinical trial?

"This study is enrolling 379 patients with medulloblastoma between the ages of 3 and 21. Most importantly, patients must meet the following criteria: - They cannot be taking any strong inhibitors or inducers of cytochrome P450 3A4. Examples of these drugs include azole antifungals and rifampin.- They must have a Karnofsky performance level of >= 30 for patients > 16 years of age or a Lansky performance scale of >= 30 for patients =< 16 years of age and life expectancy > 8 weeks.- They must be newly diagnosed and previously untreated"

Answered by AI
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~21 spots leftby Mar 2025