Chemotherapy Followed by Biological Therapy in Treating Patients With Stage IV Melanoma That Cannot be Treated With Surgery
Melanoma (Skin)

About this trial
This is an interventional treatment trial for Melanoma (Skin) focused on measuring stage IV melanoma, recurrent melanoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed unresectable stage IV melanoma Measurable metastatic disease No uncontrolled brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: More than 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT and SGPT no greater than 3 times ULN Alkaline phosphatase no greater than 3 times ULN Renal: BUN no greater than 1.5 times ULN Creatinine no greater than 1.5 times ULN Cardiovascular: No significant cardiovascular disease Other: No non-malignant systemic disease No acute infection requiring IV antibiotics No alcohol or substance abuse No other condition, disease, or history of other illness that would preclude study participation No hypersensitivity, allergic reactions, or intolerance to study drugs Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy No prior interleukin-2 No other concurrent immunotherapy No concurrent investigational vaccines or immunomodulatory agents No other concurrent growth factors Chemotherapy: At least 4 weeks since prior chemotherapy No prior temozolomide No other concurrent anticancer chemotherapy Endocrine therapy: No concurrent steroids (including corticosteroids) Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: See Disease Characteristics At least 3 weeks since prior major surgery Other: At least 30 days since prior immune-based therapy No concurrent participation in other clinical trials with investigational drugs No other concurrent anticancer drugs No concurrent immunosuppressive therapy No concurrent levamisole or cimetidine
Sites / Locations
- Saint Francis Memorial Hospital
- John Wayne Cancer Institute at Saint John's Health Center
- University of Colorado Cancer Center at University of Colorado Health Sciences Center