Temozolomide and Thalidomide in Treating Patients With Metastatic, Locally Advanced, or Unresectable Leiomyosarcoma
- Conditions
- Sarcoma
- Registration Number
- NCT00033709
- Lead Sponsor
- Herbert Irving Comprehensive Cancer Center
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining temozolomide with thalidomide may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining temozolomide with thalidomide in treating patients who have metastatic, locally advanced, or unresectable leiomyosarcoma.
- Detailed Description
OBJECTIVES:
* 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 these patients.
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 months.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response (complete and partial response)
- Secondary Outcome Measures
Name Time Method Time to progression Clinical benefit Overall survival
Trial Locations
- Locations (1)
Herbert Irving Comprehensive Cancer Center at Columbia University
🇺🇸New York, New York, United States
Herbert Irving Comprehensive Cancer Center at Columbia University🇺🇸New York, New York, United States