Thalidomide in Treating Patients With 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.

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed sarcoma or carcinosarcoma (mixed mesodermal tumors) of gynecologic origin not amenable to resection or radiotherapy
• Measurable disease

• Lesions accurately measured in at least 1 dimension of at least 20 mm in longest diameter with conventional techniques or at least 10 mm with helical CT scan
• Histologically or cytologically confirmed neoplastic nature if solitary lesion
• No nonmeasurable disease, defined as:

• Bone lesions
• Leptomeningeal disease
• Ascites
• Pleural/pericardial effusion
• Inflammatory breast disease
• Lymphangitis cutis/pulmonis
• Unconfirmed abdominal masses not followed by imaging techniques
• Cystic lesions
• Documented recurrence or persistence following appropriate surgery, radiotherapy, and/or chemotherapy
• Postmenopausal or status post hysterectomy

PATIENT CHARACTERISTICS:

Age:

• Not specified

Performance status:

• ECOG 0-1

Life expectancy:

• Not specified

Hematopoietic:

• Granulocyte count at least 1,000/mm^3
• Platelet count at least 50,000/mm^3

Hepatic:

• Bilirubin normal
• Transaminases less than 2.5 times upper limit of normal

Renal:

• Creatinine less than 1.5 mg/dL

Other:

• No grade 2 or greater peripheral neuropathy
• No medical or social factors that would preclude study, including inability to take oral medication
• No other serious illness requiring immediate therapy
• Not pregnant

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics
• At least 4 weeks since prior chemotherapy (6 weeks since mitomycin or nitrosoureas)

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics
• At least 4 weeks since prior radiotherapy
• No concurrent radiotherapy

Surgery:

• See Disease Characteristics

Other:

• At least 30 days since any prior noncytotoxic experimental antiemetic or antifungal investigational drug