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
- 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
Jeffrey J. Raizer, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|