Biological Therapy and Temozolomide in Treating Patients With Metastatic Melanoma
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 or cytologically confirmed metastatic melanoma No ocular or mucosal melanoma Must meet one of the following criteria: Failed standard or salvage therapy Ineligible for standard therapy due to concurrent illness Declined standard therapy Received at least 1 prior therapy for metastatic disease Brain metastasis as only site of metastatic disease allowed if there is documented evidence of progression after at least 1 prior treatment for metastases No leptomeningeal metastases At least 1 documented site of bidimensionally measurable disease by MRI or CT scan Previously irradiated lesions not considered measurable unless documented disease progression after radiotherapy PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: More than 3 months Hematopoietic: WBC at least 3,000/mm^3 Absolute neutrophil count greater than 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 10 g/dL No coagulation disorder such as thrombophlebitis Hepatic: Bilirubin less than 2.0 mg/dL AST and ALT less than 3 times upper limit of normal (ULN) Alkaline phosphatase less than 3 times ULN Renal: Creatinine less than 1.5 times ULN BUN less than 1.5 times ULN Cardiovascular: Ejection fraction at least 45% No active ischemia No unstable angina No uncontrolled congestive heart failure Pulmonary: Normal pulmonary function tests within the past month FEV1 or FVC more than 65% predicted No uncontrolled pulmonary embolism Gastrointestinal: No frequent vomiting No medical condition that would preclude oral medication intake (e.g., partial bowel obstruction) Other: No prolonged grade 4 myelosuppression from prior dacarbazine lasting more than 3 weeks No uncontrolled cortical dysfunction No other major medical illness (e.g., active systemic infection, autoimmune disease, or uncontrolled thyroid abnormality) No other malignancy within the past 5 years except resected basal cell carcinoma or carcinoma in situ of the cervix No significant psychiatric disease that would preclude study compliance No AIDS-related illness HIV negative Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: See Disease Characteristics Biologic therapy: More than 1 month since prior biologic therapy or immunotherapy Chemotherapy: More than 1 month since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) Endocrine therapy: At least 4 weeks since prior steroid therapy or steroid-containing compounds At least 2 weeks since prior topical or inhaled steroids Radiotherapy: See Disease Characteristics More than 1 month since prior radiotherapy, interstitial brachytherapy, or radiosurgery Surgery: At least 1 week since prior surgery
Sites / Locations
- Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center