Brain and Central Nervous System Tumors Clinical Trial
Official title:
A Phase I Study of Extended Low Dose Temozolomide (SCH 52365, Temodar (R)) and Carmustine (BCNU) in the Treatment of Malignant Gliomas After Radiation Therapy
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor
cells.
PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy following
radiation therapy in treating patients who have malignant glioma.
OBJECTIVES:
- Determine the safety and efficacy of extended low-dose temozolomide when combined with
carmustine after radiotherapy in patients with malignant glioma.
- Determine the maximum tolerated dose of this combination in this patient population.
- Determine time to progression as measured from baseline gadolinium-enhanced magnetic
resonance imaging in patients treated with this regimen.
OUTLINE: This is a dose-escalation study of temozolomide.
Patients receive oral temozolomide once daily on days 1-28 and carmustine IV over 1-3 hours
beginning within 72 hours after starting temozolomide. Courses repeat every 8 weeks for up
to 1 year in the absence of unacceptable toxicity or disease progression.
Cohorts of 3-6 patients receive escalating doses of temozolomide until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6
patients experience dose-limiting toxicity.
Patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for this study within 1-2 years.
;
Primary Purpose: Treatment
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