A Phase II Study of Combination Therapy of a Protracted Oral Schedule of Temozolomide and Thalidomide as First-Line or Subsequent Therapy for Patients With Metastatic, Locally Advanced or Unresectable Leiomyosarcoma
- Determine the efficacy of temozolomide and thalidomide in patients with metastatic,
locally advanced, or unresectable leiomyosarcoma.
- Determine the time to progression in patients treated with this regimen.
- Determine the overall survival of patients treated with this regimen.
- Determine the clinical and laboratory toxic effects and tolerability of this regimen in
OUTLINE: Patients receive oral temozolomide once daily for 7 days every other week and oral
thalidomide once daily. Treatment continues for up to 26 weeks in the absence of disease
progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study within 7.5-25
Primary Purpose: Treatment
Response (complete and partial response)
Robert N. Taub, MD, PhD
Herbert Irving Comprehensive Cancer Center
United States: Federal Government
|Herbert Irving Comprehensive Cancer Center at Columbia University||New York, New York 10032|