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.
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.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
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New York, New York, United States
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