Research

Medulloblastoma Treatment with Carboplatin and Isotretinoin – Phase III

Efficacy of Carboplatin Administered Concomitantly With Radiation and Isotretinoin as a Pro-Apoptotic Agent in Other Than Average Risk Medulloblastoma/PNET Patients

Protocol Description

This Children’s Oncology Group Phase III trial is studying different chemotherapy and radiation therapy regimens to compare how well they work in treating young patients with newly diagnosed, previously untreated, high-risk medulloblastoma or supratentorial primitive neuroectodermal tumor (PNET). More specifically, it will determine whether radiation therapy and carboplatin together are more effective than radiation therapy alone, and whether isotretinoin can improve treatment outcomes.

Study Level: Phase III

Eligibility Criteria

Subject to certain exclusion criteria, the study is open to individuals of both genders, from age 3 to 21, who have been diagnosed with medulloblastoma or supratentorial PNET.
Males: Ages 3 to 21 years
Females: Ages 3 to 21 years

Requirements
There are 4 treatment groups into which participants will be randomly assigned. Treatment begins within 31 days of tumor removal. For the first 6 weeks, all groups will receive radiation therapy plus the anti-cancer drug vincristine, which is the standard treatment. For the 6-month maintenance chemotherapy stage that follows, 2 of the groups will also receive carboplatin. One of the carboplatin groups and one of the standard care groups will also recieve maintenance and additional continuation therapy with a chemotherapy regigmin that will include isotretinoin.
Frequency of visits: 5 days a week for the initial cycle; follow-up cycles vary
Duration: Approximately 9 to 15 months, depending on which treatment arm participant is assigned

Status: Open for Enrollment

Source(s) of Support
Children’s Oncology Group (Study ACNS0332)
National Cancer Institute
Third Party

Additional Resources
Study Description at National Institutes of Health