A Randomized Phase II Trial of a Mutated gp100 Melanoma Peptide (g209-217(210M) With Hight Dose Interleukin-2 (IL-2) in HLA-A2.1+Patients With Metastatic Melanoma

Date de début de l'étude : 1 novembre 1998

DISEASE CHARACTERISTICS: Histologically confirmed clearly progressive metastatic or unresectable melanoma Must be HLA-A2.1 positive Measurable disease No active brain metastases, leptomeningeal disease, or seizure disorder More than 4 months since prior definitive therapy (surgery or radiotherapy) for brain metastases and must not have evidence of disease on brain CT scan or MRI No ascites or pleural effusions PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 OR Karnofsky 80-100% Life expectancy: Not specified Hematopoietic: WBC at least 3,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin no greater than 2.0 mg/dL Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No congestive heart failure No symptoms of coronary artery disease No serious cardiac arrhythmias No evidence of prior myocardial infarction on EKG Normal cardiac stress test required for all patients over 40 years Pulmonary: FEV_1 greater than 2.0 liters or at least 75% of predicted No chronic obstructive pulmonary disease Other: HIV negative No significant systemic infection No contraindication to use of pressor agents No history of major psychiatric illness No other major illness that would significantly increase the risk of immunotherapy No other active malignancy except surgically cured nonmelanoma skin cancer or carcinoma in situ or stage I carcinoma of the cervix Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No prior interleukin-2 At least 4 weeks since prior vaccine therapy or other cytokine therapy Chemotherapy: One prior chemotherapy regimen allowed At least 4 weeks since prior chemotherapy (6 weeks for carmustine or lomustine) and recovered Endocrine therapy: No concurrent steroids Radiotherapy: See Disease Characteristics No prior radiotherapy to areas of measurable disease unless there has been clearly progressive disease in this site or there is measurable disease outside of areas of prior radiation At least 2 weeks since prior radiotherapy for local control or palliative therapy and recovered Surgery: See Disease Characteristics Recovered from prior major surgery No prior organ allografts Other: No antihypertensive therapy within 24 hours prior to interleukin-2