Research

Medulloblastoma and Supratentorial PNET Treatment with Methotrexate – Phase III

Treatment of Newly Diagnosed Supratentorial PNET and High Risk Medulloblastoma in Children Less Than 36 Months Old with Intensive Induction Chemotherapy with Methotrexate Followed by Consolidation with Stem Cell Rescue vs. the Same Therapy Without Methotrexate

Protocol Description

This Children’s Oncology Group Phase III trial is studying two different combination chemotherapy regimens to compare how well they work when given before a peripheral stem cell transplant in treating very young patients with newly diagnosed supratentorial primitive neuroectodermal tumors (PNET) or high-risk medulloblastoma. Researchers hope to learn whether adding methotrexate will prove more effective than not adding methotrexate during induction therapy

Study Level: Phase III

Eligibility Criteria

Subject to certain exclusion criteria, the study is open to individuals of both genders up to 36 months of age, who have been diagnosed with high-risk medulloblastoma or supratentorial PNET.
Males: Up to 36 months old
Females: Up to 36 months old

Requirements
There are 2 treatment groups into which participants will be randomly assigned with treatment provided after initial surgery to remove the tumor. One group will get 3, 21-day cycles of induction therapy with common chemotherapy drugs. The second group will receive the same treatment with the addition of the drug methotrexate. Blood stem cells will also be collected. For participants whose tumors persist, surgery follows. The last step is 3 cycles of consolidation therapy, in which additional chemotherapy is given and the patients stem cells are returned.
Visits: Approximately 21
Duration: Approximately 6 months, with patients followed for up to 10 years

Status: Open for Enrollment

Source(s) of Support
Children’s Oncology Group (Study ACNS0334)
National Cancer Institute
Third Party

Additional Resources
Study Description at National Institutes of Health