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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)
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
I am between 6 and 10 years old with a creatinine level of 1 mg/dL or less.
My medulloblastoma is WNT type, confirmed by specific tests.
My cancer has a CTNNB1 mutation.
My medulloblastoma is of the WNT type, not the LC/A type.
My blood counts meet the required levels for neutrophils, platelets, and hemoglobin.
My kidney function is within the required range for my age and gender.
My bilirubin levels are normal and my liver enzyme (ALT) is below 135 U/L.
My cancer shows positive for beta-catenin.
My child is between 3 and 6 years old with a creatinine level of 0.8 mg/dL or less.
I am between 10 and 13 years old with a creatinine level of no more than 1.2 mg/dL.
My cancer does not have MYC or MYCN abnormalities.
My kidney function is normal or near normal.
I am 13-15 years old with a creatinine level below 1.5 (male) or 1.4 (female).
I am over 16 and my kidney function tests are within the normal range.
My bilirubin levels are within normal range for my age.
My tumor is less than 1.5 cm^2, confirmed by a special imaging review.
I am between 3 and 21 years old.


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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free survival (PFS)
Secondary outcome measures
Body Weight Changes
Deoxyribonucleic acid (DNA) methylation profiling as real-time classification of WNT-driven medulloblastoma
Other outcome measures
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

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.
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
Completed Phase 3
Completed Phase 3
Completed Phase 3
Completed Phase 4
Completed Phase 3
Vincristine Sulfate
Completed Phase 3
Radiation Therapy
Completed Phase 3

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,108 Total Patients Enrolled
89 Trials studying Medulloblastoma
10,340 Patients Enrolled for Medulloblastoma
Children's Oncology GroupLead Sponsor
453 Previous Clinical Trials
237,655 Total Patients Enrolled
17 Trials studying Medulloblastoma
3,715 Patients Enrolled for Medulloblastoma
Nicholas J GottardoPrincipal InvestigatorChildren's Oncology Group

Media Library

Cisplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT02724579 — Phase 2
Medulloblastoma Research Study Groups: Treatment (reduced radiation therapy and chemotherapy)
Medulloblastoma Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT02724579 — Phase 2
Cisplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02724579 — Phase 2

Frequently Asked Questions

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

For what medical treatments is Cyclophosphamide usually prescribed?

"While often used to treat lymphoma, cyclophosphamide can also help patients with acute lymphoblastic leukemia (ALL), ovarian germ cell tumour, and brain cancer."

Answered by AI

How many people have been asked to participate in this clinical trial?

"That is accurate, the listing on clinicaltrials.gov says that this study is open for enrollment. The trial was first posted on October 2nd, 2017 and has since been edited September 14th of this year. A total of 45 individuals are being sought across 100 different locations."

Answered by AI

Are octogenarians able to participate in this research project?

"In order to take part in this particular study, patients must be between the ages of 3 and 21. Out of 435 clinical trials, this is one of the 1387 that specifically focuses on people over the age of 65."

Answered by AI

Has the United States Food and Drug Administration cleared Cyclophosphamide for public use?

"While there is some evidence that Cyclophosphamide is safe, it has not been proven effective yet and thus received a 2."

Answered by AI

Are new participants being recruited for this experiment?

"The study, which was posted on October 2nd 2017 and edited September 14th 2022, is looking for patients who match the given criteria."

Answered by AI

Might I be able to enroll in this particular clinical trial?

"In order to meet the needs of this trial, researchers are looking for 45 young patients aged 3-21 that have medulloblastoma. Most importantly, these potential participants must meet the following requirements: They must be enrolled and ready to begin protocol therapy no more than 36 days after having definitive diagnostic surgery (day 0)."

Answered by AI

Are there any other hospitals conducting this research in the city?

"This study is being conducted in several hospitals, with Alberta Children's Hospital in Calgary, Alberta, Carolinas Medical Center/Levine Cancer Institute in Charlotte, North carolina and New york Medical College in Valhalla, New York being a few of the 100 locations."

Answered by AI

Could you please outline any other research that has been completed with Cyclophosphamide?

"There are presently 1637 active trials studying Cyclophosphamide, with 455 of those in Phase 3 Clinical Trials. The majority of these studies originate from Philadelphia, but there are 74031 locations where Cyclophosphamide clinical trials are taking place."

Answered by AI
~15 spots leftby Jun 2027