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

This is an interventional treatment trial for Melanoma (Skin) focused on measuring recurrent melanoma, stage IV melanoma Read More

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