Thalidomide in Treating Patients With Gynecologic Sarcomas
- Conditions
- Endometrial CancerSarcoma
- Registration Number
- NCT00006005
- Lead Sponsor
- New York University Cancer Institute
- Brief Summary
RATIONALE: Thalidomide may stop the growth of gynecologic sarcomas by stopping blood flow to the tumor.
PURPOSE: Phase II trial to study the effectiveness of thalidomide in treating patients who have recurrent or persistent gynecologic sarcomas.
- Detailed Description
OBJECTIVES:
* Determine the impact on survival and the antitumor effects of thalidomide in patients with sarcomas or carcinosarcoma (mixed mesodermal tumors) of gynecologic origin.
* Determine the safety and side effect profiles of the target dose of this treatment regimen in this patient population.
* Determine the antiangiogenic and immunologic effects of this treatment regimen in these patients.
OUTLINE: Patients receive oral thalidomide daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 18 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
North Shore University Hospital
🇺🇸Manhasset, New York, United States
New York Medical College
🇺🇸Valhalla, New York, United States
Mount Sinai School of Medicine
🇺🇸New York, New York, United States
University of Wisconsin Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
St. Luke's-Roosevelt Hospital Center - Roosevelt Division
🇺🇸New York, New York, United States
New York Weill Cornell Cancer Center at Cornell University
🇺🇸New York, New York, United States
Albert Einstein Clinical Cancer Center
🇺🇸Bronx, New York, United States
Cancer Center of Albany Medical Center
🇺🇸Albany, New York, United States
St. Vincent's Comprehensive Cancer Center
🇺🇸New York, New York, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
🇺🇸New York, New York, United States