RATIONALE: Thalidomide may stop the growth of cancer 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 cancer of the uterus.

OBJECTIVES:

• Determine the antitumor cytostatic activity of thalidomide, as measured by the probability of progression-free survival (PFS) for at least 6 months, in patients with recurrent or persistent uterine leiomyosarcoma.
• Determine the nature and degree of the toxicity of this drug in these patients.
• Determine the partial and complete response rates in patients treated with this drug.
• Determine the duration of PFS and overall survival of patients treated with this drug.
• Determine the effect of this drug on initial performance status in these patients.
• Determine the effects of this drug at 4 weeks on endogenous angiogenesis factors (vascular endothelial growth factor and basic fibroblast growth factor) in plasma and urine of these patients.
• Assess the association of endogenous angiogenesis factors with clinical outcome (PFS) in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive oral thalidomide once daily on days 1-28. Courses repeat every 4 weeks 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 22-60 patients will be accrued for this study within 7-21 months.

DISEASE CHARACTERISTICS:

• Histologically confirmed primary uterine leiomyosarcoma (LMS) that is refractory to curative therapy or established treatments

  • Recurrent or persistent disease

• At least 1 unidimensionally measurable target lesion

  • At least 20 mm by conventional techniques, including palpation, plain x-ray, CT scan, or MRI OR at least 10 mm by spiral CT scan
  • Tumors within a previously irradiated field are considered non-target lesions
• No smooth muscle tumor of uncertain malignant potential, including metastatic or recurrent disease from such a tumor
• Must have received 1 prior initial chemotherapy regimen (including high-dose, consolidation, or extended therapy after surgical or nonsurgical assessment) for uterine LMS
• Ineligible for a higher priority Gynecological Oncology Group (GOG) protocol (if one exists), including any active phase III protocol for the same patient population

• No documented brain metastases since diagnosis of cancer

  • Patients with stable CNS deficits are allowed provided there are no brain metastases, as confirmed by CT scan or MRI

PATIENT CHARACTERISTICS:

Age:

• Not specified

Performance status:

• GOG 0-2 if received 1 prior therapy regimen
• GOG 0-1 if received 2 prior therapy regimens

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• SGOT no greater than 2.5 times ULN
• Alkaline phosphatase no greater than 2.5 times ULN

Renal:

• Creatinine no greater than 1.5 times ULN OR
• Creatinine clearance greater than 60 mL/min

Other:

• No documented seizure disorders since diagnosis of cancer
• Patients with a history of seizure disorders are allowed provided that the seizures have been stable (i.e., no seizure within the past 12 months)while on an appropriately monitored treatment regimen
• No active infection requiring antibiotics
• No greater than grade 1 sensory or motor neuropathy
• No other prior invasive malignancy within the past 5 years except nonmelanoma skin cancer
• Not pregnant
• Negative pregnancy test
• Fertile patients must use at least 1 highly active method and 1 additional effective method of contraception for at least 4 weeks before, during, and for at least 4 weeks after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior thalidomide
• At least 3 weeks since prior immunologic agents for uterine LMS

Chemotherapy:

• See Disease Characteristics
• At least 3 weeks since other prior chemotherapy for uterine LMS and recovered
• No more than 1 prior cytotoxic chemotherapy regimen for recurrent or persistent uterine LMS
• No prior non-cytotoxic chemotherapy for recurrent or persistent uterine LMS

Endocrine therapy:

• At least 1 week since prior hormonal therapy for uterine LMS
• Concurrent hormone replacement therapy allowed

Radiotherapy:

• See Disease Characteristics
• At least 3 weeks since prior radiotherapy for uterine LMS and recovered
• No prior radiotherapy to more than 25% of bone marrow

Surgery:

• See Disease Characteristics
• Recovered from recent prior surgery

Other:

• No prior anticancer therapy that would preclude study therapy
• At least 3 weeks since other prior therapy for uterine LMS
• No concurrent bisphosphonates (e.g., zoledronate)