Thalidomide in Treating Patients With Gynecologic Sarcomas
|ClinicalTrials.gov Identifier: NCT00006005|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 21, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Cancer Sarcoma||Drug: thalidomide||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Phase II Study of Thalidomide (NSC #66847) in Patients With Sarcomas of Gynecologic Origin|
|Study Start Date :||September 2000|
|Study Completion Date :||August 2006|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006005
|United States, New York|
|Cancer Center of Albany Medical Center|
|Albany, New York, United States, 12208|
|Albert Einstein Clinical Cancer Center|
|Bronx, New York, United States, 10461|
|North Shore University Hospital|
|Manhasset, New York, United States, 11030|
|St. Vincent's Comprehensive Cancer Center|
|New York, New York, United States, 10011|
|NYU School of Medicine's Kaplan Comprehensive Cancer Center|
|New York, New York, United States, 10016|
|St. Luke's-Roosevelt Hospital Center - Roosevelt Division|
|New York, New York, United States, 10019|
|New York Weill Cornell Cancer Center at Cornell University|
|New York, New York, United States, 10021|
|Mount Sinai School of Medicine|
|New York, New York, United States, 10029|
|New York Medical College|
|Valhalla, New York, United States, 10595|
|United States, Wisconsin|
|University of Wisconsin Comprehensive Cancer Center|
|Madison, Wisconsin, United States, 53792-6164|
|Study Chair:||Scott Wadler, MD||Weill Medical College of Cornell University|