RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who have advanced soft tissue sarcoma.

OBJECTIVES: I. Determine the efficacy, as measured by the response rate, of temozolomide in patients with unresectable, stage IV, or recurrent soft tissue sarcoma who have failed no more than 2 prior treatment regimens. II. Determine the clinical and laboratory toxicities, as well as patient tolerance, of this regimen in this patient population.

PROTOCOL OUTLINE: Patients are stratified according to ECOG performance status (0-1 vs 2), prior surgery (yes vs no), prior radiotherapy (yes vs no), and prior chemotherapy regimens (0 vs 1 vs 2). Patients receive oral temozolomide every 12 hours for 5 days. Courses repeat every 4 weeks for at least 18 months in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for the first 18 months, every 6 months for the next 18 months, and then annually thereafter until death.

PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically, cytologically, or clinically confirmed unresectable, stage IV, or recurrent soft tissue sarcoma; No Ewing's sarcoma, Kaposi's sarcoma, bone sarcomas, mesotheliomas, or primitive neuroectodermal tumors
• Bidimensionally measurable disease by x-ray, CT scan or MRI, or physical examination
• No CNS metastases
• No more than 2 prior chemotherapy regimens for advanced, recurrent, or metastatic disease

--Prior/Concurrent Therapy--

• Biologic therapy: Prior biologic response modifier treatment allowed; At least 4 weeks since prior immunotherapy; At least 4 weeks since prior biologic therapy; No concurrent epoetin alfa
• Chemotherapy: See Disease Characteristics; Prior dacarbazine allowed; At least 4 weeks since prior chemotherapy; No other concurrent chemotherapy
• Endocrine therapy: No concurrent hormonal therapy for malignancy
• Radiotherapy: At least 3 weeks since prior radiotherapy and recovered; No prior radiotherapy to areas of measurable disease unless there is clear progression or there is measurable disease outside the area of prior radiation; No concurrent radiotherapy
• Surgery: At least 4 weeks since prior surgery and recovered
• Other: No other concurrent investigational drugs

--Patient Characteristics--

• Age: 18 and over
• Performance status: ECOG 0-2
• Life expectancy: Greater than 12 weeks
• Hematopoietic: Platelet count at least 100,000/mm3; Hemoglobin greater than 10.0 g/dL; WBC at least 3,500/mm3 OR Absolute neutrophil count at least 1,500/mm3
• Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN); SGOT/SGPT no greater than 1.5 times ULN; Alkaline phosphatase less than 2 times ULN
• Renal: Calcium less than ULN; Creatinine or BUN less than 1.5 times ULN OR Creatinine clearance greater than 60 mL/min
• Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or fully excised and/or treated stage I cancer currently in complete remission; No nonmalignant systemic disease rendering patient a poor medical risk; No acute infection requiring IV antibiotics HIV negative; No AIDS-related illness; No frequent vomiting or medical condition that could interfere with oral medication intake (e.g., partial bowel obstruction)