Brain and Central Nervous System Tumors Clinical Trial
Official title:
Phase II Study of Temozolomide and Radiation in Newly Diagnosed GBM Patients After Resection and Insertion of Gliadel® Wafers
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop
the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Radiation therapy uses high-energy x-rays to kill tumor cells. Giving temozolomide during and
after radiation therapy may kill any tumor cells that remain after surgery and placement of
Gliadel wafers.
PURPOSE: This phase II trial is studying how well giving temozolomide during and after
radiation therapy works in treating patients who have undergone previous surgery and
placement of Gliadel wafers for newly diagnosed glioblastoma multiforme.
OBJECTIVES:
- Determine the efficacy of adjuvant temozolomide when administered during and after
external beam radiotherapy, in terms of survival, in patients with newly diagnosed
glioblastoma multiforme who have undergone prior total surgical resection and placement
of polifeprosan 20 with carmustine implant (Gliadel® wafers).
OUTLINE: This is an open-label study.
Patients undergo external beam radiotherapy 5 days a week for 6 weeks and concurrently
receive oral temozolomide once daily for 6 weeks. No more than 28 days later, patients
receive additional oral temozolomide once daily on days 1-5. Treatment with temozolomide
repeats every 28 days for up to 6 courses in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed every 2 months for survival.
PROJECTED ACCRUAL: A total of 72 patients will be accrued for this study within 18 months.
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