High-Risk Medulloblastoma Treatment with Chemotherapy and Radiation – 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 multicenter trial by the Children’s Oncology Group 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. In particular, investigators will be examining whether carboplatin in combination with radiation is more effective on tumor cells than radiation alone.

Study Level: Phase III

Eligibility Criteria

Subject to certain exclusion criteria, this study is open to patients of both genders ages 3 to 21, who have been diagnosed as having M0 medulloblastoma, M+ medulloblastoma or diffusely anaplastic medulloblastoma.
Males and Females: Ages 3 to 21

Requirements

There are two arms to the study. Arm A is standard chemoradiotherapy and maintenance therapy; Arm B adds carboplatin to the chemoradiotherapy. The chemoradiotherapy portion of each arm is 6 weeks followed by a 6-week rest period. The maintenance and continuation stages comprise 6, 28-day cycles.
Visits: Same number as required with standard therapy
Duration: Approximately 9 to15 months depending on study arm

Status: Open to Enrollment

Source(s) of Support

Children’s Oncology Group (ACNS0322)
National Cancer Institute

Primary Investigator

Jean Tersak, MD

Contact Information

For more information about the study or enrollment, please contact:
Research Coordinator Angela Connelly, RN, BSN
412-692-8864