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Alternate Title Phase III Study of Radiotherapy, High-Dose Cisplatin, Vincristine, and Cyclophosphamide, and Autologous Stem Cell Rescue in Patients With Newly Diagnosed Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor
Trial Description Drugs used in chemotherapy, such as vincristine, cisplatin, and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. Autologous stem cell transplant may be able to replace blood- forming cells that were destroyed by chemotherapy or radiation therapy. It is not yet known which radiation therapy regimen combined with chemotherapy and donor stem cell transplant is more effective in treating medulloblastoma, supratentorial primitive neuroectodermal tumor, or atypical teratoid rhabdoid tumor. This phase III trial is studying two different regimens of radiation therapy when given together with chemotherapy and autologous stem cell transplant to see how well they work in treating patients with newly diagnosed medulloblastoma, supratentorial primitive neuroectodermal tumor, or atypical teratoid rhabdoid tumor. Eligibility criteria include the following:
Final eligibility for a clinical trial is determined by the health professionals conducting the trial. Stem cells or bone marrow will be collected from patients. Patients will then undergo one of two regimens of radiation therapy to the head and spine 5 days a week for 6 weeks. Six weeks after completing radiation therapy, patients will receive an infusion of vincristine and a 6-hour infusion of cisplatin on day 1 followed by a 1-hour infusion of cyclophosphamide on days 2-3. Patients will undergo donor stem cell transplant on day 5. They will receive an injection of filgrastim beginning on day 6 and continuing until blood counts return to normal. Patients will receive an infusion of vincristine on day 11. Treatment may be repeated every 4 weeks for three courses. Some patients will periodically undergo neurological examinations. After finishing treatment, patients will be evaluated every 3 months until 2.5 years after diagnosis and every 6 months until 6 years after diagnosis. Important: For more details about this trial, refer to the Health Professional version of the trial summary. If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site. Trial Lead Organizations St. Jude Children's Research Hospital
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