Clinical Trial: Cancer

Standard Risk Medulloblastoma Study

Full Name

Temporarily Closed to Enrollment/ Standard Risk Medulloblastoma (COG #ACNS0331): A Study Evaluating Limited Target Volume Boost Irradiation and Reduced Dose Craniospinal Radiotherapy (18.00 Gy) and Chemotherapy in Children with Newly Diagnosed Standard Risk Medulloblastoma: A Phase III Double Randomized Trial (2_PRO00000296)

Description

At a previous point in time this study enrolled participants who were 8 years of age and older. However, that arm of the study reached its enrollment goal, so the study is now only enrolling participants between the ages of 3 and 7. Participants will be randomly assigned twice. First, they will be randomly assigned to receive either a reduced dose of craniospinal radiation or a standard dose. After that, participants will be randomly assigned to receive either a standard volume boost (radiation to the entire posterior fossa) or a smaller volume boost (radiation to tumor bed). All participants receive weekly vincristine doses during radiation therapy. Vincristine is given directly into the vein through an IV once a week for 6 weeks. After the radiation is complete, participants will receive 9 cycles of Maintenance chemotherapy. There are two different kinds of cycles given. Cycle A lasts for 42 days (6 weeks), and Cycle B lasts for 28 days (4 weeks). B cycles are given after the completion of 2 A cycles. This study also includes optional neuropsychological testing, biology testing and quality of life sub-studies. Participants can take part in the main study without having to take part in the optional sub-studies.

Eligibility

Inclusion Criteria

o Must be greater than or equal to 3 years of age and less than or equal to 7 years of age at the time of diagnosis
o Must have a confirmed diagnosis of medulloblastoma
o Must not have had previous radiotherapy or chemotherapy other than corticosteroids
o Must have adequate kidney and liver function
o Must have adequate bone marrow function