Brain and Central Nervous System Tumors Clinical Trial
Official title:
A Phase 2 Study of O-Benzylguanine (O-BG) and Temozolomide in Patients With Glioblastoma Progressing at Least 3 Months After Completion of Primary Treatment With Radiation Therapy and Temozolomide
RATIONALE: Drugs used in chemotherapy, such as O(6)-benzylguanine and temozolomide, work in
different ways to stop the growth of tumor cells, either by killing the cells or by stopping
them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor
cells.
PURPOSE: This phase II trial is studying the side effects and how well giving
O(6)-benzylguanine together with temozolomide works in treating patients with glioblastoma
multiforme that did not respond to previous temozolomide and radiation therapy.
OBJECTIVES:
- Determine the antitumor activity of O6-benzylguanine and temozolomide in patients with
temozolomide-resistant methylguanine methyltransferase-positive or -negative
glioblastoma multiforme previously treated with radiotherapy.
- Determine, preliminarily, the toxicity of this regimen in these patients.
OUTLINE: Patients receive O6-benzylguanine IV over 1 hour and oral temozolomide once daily
on days 1-5. Treatment repeats every 28 days in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed periodically for at least 6
months.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.
;
Masking: Open Label, Primary Purpose: Treatment
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