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A Phase III Study of Intensive Induction Chemotherapy with or without Methotrexate Followed by Consolidation Therapy with Stem Cell Rescue in Young Children Newly Diagnosed with Supratentorial PNET or High-Risk Medulloblastoma

[Protocol 07-170]

Full Title :

A PHASE III RANDOMIZED TRIAL FOR THE TREATMENT OF NEWLY DIAGNOSED SUPRATENTORIAL PNET AND HIGH RISK MEDULLOBLASTOMA IN CHILDREN < 36 MONTHS OLD WITH INTENSIVE INDUCTION CHEMOTHERAPY WITH METHOTREXATE FOLLOWED BY CONSOLIDATION WITH STEM CELL RESCUE VS. THE SAME THERAPY WITHOUT METHOTREXATE (COG ACNS0334)

Purpose :

Supratentorial primitive neuroectodermal tumor (PNET) and medulloblastoma are types of brain tumors. Medulloblastoma is considered to be high risk if surgery could not remove the entire tumor, if the cerebrospinal fluid has tumor cells in it, or if there are additional sites of tumor cells in the brain or spine. The purpose of this phase III Children's Oncology Group study is to compare the effectiveness of two investigational treatment regimens in very young children with these cancers.

Patients will be randomly assigned to one of two groups. One group will receive intensive "induction" chemotherapy (the drugs vincristine, etoposide, cyclophosphamide, and cisplatin) plus methotrexate, followed by "consolidation" therapy with stem cell rescue (to help the patient's immune system re-establish itself). The second group will receive the same therapy without the methotrexate.

Eligibility :

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

• Patients must have a confirmed diagnosis of supratentorial PNET or high-risk medulloblastoma that has not yet been treated with chemotherapy or radiation therapy.
• Patients must be under age 3.

For more information and to inquire about eligibility for this study, please contact Dr. Stephen W. Gilheeney at 212-639-3973 or Dr. Yasmin Khakoo at 212-639-8292.