Protocol Number: 06-C-0089
Temozolomide kills cancer cells by damaging their genetic material (DNA). The drug is approved for treating certain adult brain tumors, but no study has been able to show that it works in children with the same type of tumor. O(6)-BG inactivates a protein called AGT that cancer cells use to repair damage from temozolomide. Combining temozolomide and O(6)-BG may make temozolomide more effective in killing tumor cells. Objectives: To find out how well O6-BG and temozolomide work together in treating brain tumors. To learn more about the side effects that may occur when O(6)-BG is given with temozolomide. To learn more about how tumors respond to combined treatment with O(6)-BG and temozolomide. Eligibility: Patients 21 or younger with a high-grade glioma or brainstem tumor who have received standard therapy, including radiation therapy if that is standard for patient age, and who have had no more than two recurrences or progressions. Design: Chemotherapy: Study drugs are given once a day for 5 consecutive days every 4 weeks. O(6)-BG is infused into a vein over one hour; 30 minutes later, temozolomide is given by mouth. Patients may receive up to 12 treatment cycles on this study. Blood tests: Routine blood tests are done twice a week during cycle 1, then once a week in future courses. Routine physical examination before every cycle. Pregnancy test every cycle in women who can bear children. Brain magnetic resonance imaging (MRI) before courses 3, 5, 7, 9 and 11. Spine MRI before courses 3, 5, 7, 9 and 11 (if necessary). Magnetic resonance spectroscopy and magnetic resonance perfusion/diffusion scans for research purposes before courses 3, 5, 7, 9 and 11.
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