M0 Medulloblastoma Treatment in Young Children – Phase II

Study for the Treatment of Non-Metastatic Nodular Desmoplastic Medulloblastoma in Children Less Than 4 Years of Age

Protocol Description

This multicenter trial by the Children’s Oncology Group studies how well combination chemotherapy works in treating younger patients with newly diagnosed, non-metastatic (M0) desmoplastic medulloblastoma. Researchers believe that it may be possible to minimize the risk of certain long-term negative effects of today’s standard chemotherapy for this condition by providing the drug methotrexate intravenously rather than intraventricularly (delivered directly into the fluid containing spaces in the brain), as part of combination chemotherapy.

Study Level: Phase II

Eligibility Criteria

Subject to certain exclusion criteria, this study is open to patients of both genders up to 47 months of age who have been diagnosed as having M0 desmoplastic medulloblastoma.
Males and Females: Less than 4 years old

Requirements

Within 36 days of the initial screening stage, in which tissue is surgically removed from the tumor to confirm diagnosis, study participants will receive three to five cycles of chemotherapy. The first stage, induction therapy, comprises three 63-day cycles, in which methotrexate is given, along with other drugs that are standard for treatment of this condition. If complete response is achieved after this, treatment will end. If not, patients will have two 42-day cycles of continuation therapy, which may be preceded by additional tumor-removal surgery. Participants may be invited to enroll in a related program (ALTE07C1) that studies the long-term effects of treatment on brain function.
Visits: 10 for each cycle of induction therapy; 6 for each cycle of continuation therapy
Duration: Approximately 6 to 8 months

Status: Open to Enrollment

Source(s) of Support

Children’s Oncology Group (ACNS1221)
National Cancer Institute

Primary Investigator

Andrew J. Bukowinski, MD

Contact Information

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