Thalidomide in Treating Patients With Gynecologic Sarcomas
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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|
|Actual Study Completion Date :||August 2006|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|