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

Inclusion Criteria

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