Interferon Alfa and Thalidomide in Treating Patients With Soft Tissue Sarcoma or Bone Sarcoma
Sarcoma
About this trial
This is an interventional treatment trial for Sarcoma focused on measuring stage III adult soft tissue sarcoma, localized osteosarcoma, metastatic osteosarcoma, stage II adult soft tissue sarcoma, stage IV adult soft tissue sarcoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed primary or metastatic soft tissue sarcoma or bone sarcoma at high risk of recurrence Grade III-IV tumor greater than 8 cm Grade III-IV primary tumor greater than 5 cm with positive surgical margins Grade III-IV primary tumor greater than 5 cm with distant metastases resected within 1 year of primary surgery No more than 8 weeks since prior surgical resection of primary or metastatic disease Ineligible for other high priority national or institutional study 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 10.0 g/dL Hepatic: Bilirubin less than 2.0 mg/dL SGOT or SGPT less than 3 times upper limit of normal (ULN)* Alkaline phosphatase less than 3 times ULN* No decompensated liver disease No autoimmune hepatitis No coagulation disorders NOTE: * Unless due to metastatic disease Renal: Creatinine normal Cardiovascular: No history of severely debilitating cardiovascular disease No unstable angina No uncontrolled congestive heart failure No thrombophlebitis Pulmonary: No history of severely debilitating pulmonary disease No chronic obstructive pulmonary disease No pulmonary embolism 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 No acute infection requiring systemic antibiotics No prior hypersensitivity to interferon alfa or any component of the injection No diabetes mellitus prone to ketoacidosis No severe myelosuppression No history of autoimmune disease No pre-existing thyroid abnormalities with thyroid function that cannot be maintained in the normal range No clinically significant retinal abnormalities No other serious medical or psychiatric illness that would preclude study No prior malignancy except curatively treated carcinoma in situ of the cervix or skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Prior systemic chemotherapy allowed Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy allowed Surgery: See Disease Characteristics
Sites / Locations
- Herbert Irving Comprehensive Cancer Center