Chemotherapy + Radiation for Medulloblastoma

Recruiting at 211 trial locations

Age: < 65

Sex: Any

Trial Phase: Phase 3

Sponsor: Children's Oncology Group

Must not be taking: Azole antifungals, Rifampin, Phenytoin, others

Disqualifiers: Previous chemotherapy, Radiation therapy, M4 disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

379 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase III trial studies different chemotherapy and radiation therapy regimens to compare how well they work in treating young patients with newly diagnosed, previously untreated, high-risk medulloblastoma. Chemotherapy drugs, such as vincristine sulfate, cisplatin, cyclophosphamide, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Carboplatin may make tumor cells more sensitive to radiation therapy. It is not yet known which chemotherapy and radiation therapy regimen is more effective in treating brain tumors.

Who Is on the Research Team?

Sarah E Leary

Principal Investigator

Children's Oncology Group

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I should be careful with certain kidney-damaging medications.

I have been newly diagnosed with medulloblastoma and have not received any treatment.

I have a specific type of brain tumor called diffusely anaplastic medulloblastoma.

Exclusion Criteria

My cancer has not spread to distant organs (not M4).

Enrollment of patients with supratentorial PNET discontinued

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemoradiotherapy

Patients undergo radiation therapy and receive vincristine sulfate, with carboplatin for some arms, for 6 weeks

6 weeks

5 visits per week (in-person)

Maintenance Therapy

Patients receive cisplatin, vincristine sulfate, cyclophosphamide, and filgrastim, repeating every 28 days for 6 courses

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Carboplatin
• Cisplatin
• Cyclophosphamide
• Radiation Therapy
• Vincristine Sulfate

Trial Overview 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.

How Is the Trial Designed?

Group I: Arm D (chemoradiotherapy, isotretinoin-CLOSED TO ACCRUAL) Experimental Treatment 8 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 Treatment 7 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 Treatment 10 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 Control 9 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.

Carboplatin is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Paraplatin for:

• Ovarian cancer
• Testicular cancer
• Lung cancer
• Head and neck cancer
• Brain cancer

Approved in European Union as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer

Approved in Canada as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer
• Testicular cancer

Who Is Running the Clinical Trial?

Children's Oncology Group

Lead Sponsor

Trials

467

Recruited

241,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+