Sarcoma Clinical Trial
Official title:
Phase II Study of Thalidomide (NSC #66847) in Patients With Sarcomas of Gynecologic Origin
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.
;
Primary Purpose: Treatment
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