Interleukin-2 and Sargramostim After Chemotherapy in Treating Patients With Stage III or Stage IV Melanoma
Melanoma (Skin)
About this trial
This is an interventional treatment trial for Melanoma (Skin) focused on measuring stage III melanoma, stage IV melanoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed melanoma Stage III or IV disease No primary ocular melanoma Stable disease (SD) or partial response (PR) after prior systemic chemotherapy completed at least 4 weeks ago Patients whose second post-chemotherapy evaluation (performed at least 4 weeks after the first evaluation that demonstrated SD or PR AND within 2 weeks before study entry) of disease demonstrates continued tumor shrinkage are not eligible Patients whose second evaluation shows disease progression are eligible unless one of the following is true: Lactic dehydrogenase (LDH) ≥ 2 times upper limit of normal (ULN) LDH > ULN AND is higher than the patient's highest value before systemic chemotherapy Patient has developed a new tumor measuring > 1 cm in diameter Sum of the longest diameters of the existing tumor has increased > 20% Evaluable or measurable disease Not potentially curable by surgery No active CNS metastases Solitary brain metastasis allowed if completely resected or completely ablated with radiosurgery more than 1 month before study entry PATIENT CHARACTERISTICS: Age 16 and over Performance status Karnofsky 60-100% Life expectancy Not specified Hematopoietic WBC ≥ 3,000/mm^3 Platelet count ≥ 100,000/mm^3 No active bleeding Hepatic See Disease Characteristics Bilirubin ≤ 2.0 mg/dL Renal Creatinine ≤ 1.2 mg/dL Cardiovascular Patients ≥ 50 years of age OR those with one or more cardiac risk factors must demonstrate one of the following: Normal exercise stress test Normal stress thallium test Normal comparable cardiac ischemia evaluation LVEF ≥ 40% Other No active infection requiring treatment No concurrent medical or psychiatric condition that would increase the potential toxicity of study treatment Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception PRIOR CONCURRENT THERAPY: Biologic therapy No other concurrent antineoplastic biologic response modifier therapy No concurrent antineoplastic vaccine therapy Chemotherapy See Disease Characteristics No concurrent antineoplastic chemotherapy Endocrine therapy No concurrent steroidal antiemetics No concurrent systemic corticosteroids Radiotherapy See Disease Characteristics No concurrent antineoplastic radiotherapy Surgery See Disease Characteristics Recovered from prior surgery Surgery within the past 4 weeks allowed provided there is no evidence of disease progression Other More than 4 weeks since prior therapy for melanoma No other concurrent antineoplastic experimental therapy
Sites / Locations
- Memorial Sloan-Kettering Cancer Center