Interleukin-21 in Treating Patients With Metastatic or Recurrent Malignant Melanoma

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed cutaneous malignant melanoma
• •* Recurrent or metastatic disease that is not curable by surgical or other means
• •Clinically and/or radiologically documented disease defined as at least one site of disease unidimensionally measurable ≥ 20 mm by x-ray, physical exam, or nonspiral CT scan OR ≥ 10 mm by spiral CT scan
• •Must have nonbulky metastatic disease defined as the largest measurable lesion ≤ 50 mm in maximum diameter
• •Must have primary diagnosis tumor tissue or previously resected metastatic melanoma tissue available (i.e., paraffin block or unstained slides)
• •No known brain metastases
• •PATIENT CHARACTERISTICS:
• •ECOG performance status 0-2
• •Life expectancy ≥ 12 weeks
• •Absolute granulocytes count ≥ 1,500/mm\^3
• •Platelet count ≥ 100,000/mm\^3
• •Bilirubin normal
• •Serum creatinine ≤ 1.5 times upper limit of normal (ULN)
• •AST and ALT ≤ 2.5 times ULN
• •Negative pregnancy test
• •Not pregnant or nursing
• •Fertile patients must use effective contraception during study therapy
• •No uncontrolled intercurrent illness or condition including, but not limited to, any of the following:
• •* Ongoing or active infection
• •* Symptomatic congestive heart failure
• •* Unstable angina pectoris
• •* Cardiac arrhythmia
• •* Psychiatric illness or social situation that would limit compliance with study requirements
• •No history of hemolysis or a hemolytic disorder including, but not limited to, any of the following:
• •* Sickle cell anemia
• •* Thalassemia
• •* Autoimmune hemolytic anemia
• •No history of other malignancies within the past 5 years except adequately treated nonmelanoma skin cancer, curatively treated carcinoma in situ of the cervix, or other solid tumors curatively treated with no evidence of disease
• •No known HIV, hepatitis B, or hepatitis C infection
• •Patients must reside within a 2-hour drive from a participating center
• •PRIOR CONCURRENT THERAPY:
• •No previous systemic therapy for metastatic disease
• •At least 3 months since prior adjuvant immunotherapy for recurrent melanoma
• •* No prior immunotherapy for metastatic disease
• •* No prior immunotherapy outside the adjuvant setting
• •At least 4 weeks since prior major surgery
• •At least 4 weeks since prior radiotherapy except low-dose, nonmyelosuppressive radiotherapy and recovered
• •More than 4 weeks since prior and no concurrent investigational agents or anticancer therapy
• •No prior chemotherapy including regional therapy
• •No concurrent systemic corticosteroids (e.g., prednisone or dexamethasone)
• •* Concurrent topical steroids are allowed