Temozolomide and Thalidomide in Treating Patients With Metastatic, Locally Advanced, or Unresectable Leiomyosarcoma
Sarcoma
About this trial
This is an interventional treatment trial for Sarcoma focused on measuring adult leiomyosarcoma, stage III adult soft tissue sarcoma, recurrent adult soft tissue sarcoma, stage III uterine sarcoma, stage IV uterine sarcoma, recurrent uterine sarcoma, uterine leiomyosarcoma, stage IV adult soft tissue sarcoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed leiomyosarcoma Metastatic, locally advanced, or unresectable Ineligible for other high priority national or institutional study At least 1 unidimensionally measurable lesion documented on radiologic study At least 2 cm by 2 cm Not previously irradiated unless disease progression at the site is evident No brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Life expectancy: More than 2 months Hematopoietic: WBC greater than 3,000/mm^3 Neutrophil count at least 1,500/mm^3 Platelet count greater than 70,000/mm^3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin less than upper limit of normal (ULN) SGOT or SGPT less than 1.5 times ULN* Alkaline phosphatase less than 2 times ULN* NOTE: * Less than 5 times ULN if documented liver disease Renal: Creatinine less than 1.5 times normal OR Creatinine clearance greater than 60 mL/min BUN less than 1.5 times normal Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use 2 forms of effective contraception for 4 weeks before, during, and for 4 weeks after study therapy No acute infection requiring systemic antibiotics No frequent vomiting or medical condition that would preclude intake of oral medication (e.g., partial bowel obstruction) No other serious medical or psychiatric illness that would preclude study participation No prior malignancy except curatively treated carcinoma in situ of the cervix or skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy No more than 3 prior systemic chemotherapy regimens for metastatic, locally advanced, or unresectable leiomyosarcoma Prior dacarbazine allowed Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy No prior radiotherapy to 50% or more of bone marrow Concurrent radiotherapy for local control or palliative therapy for painful bony or soft tissue lesion allowed Surgery: At least 4 weeks since prior surgery and recovered Other: Recovered from all prior therapies No other concurrent investigational drugs
Sites / Locations
- Herbert Irving Comprehensive Cancer Center at Columbia University