Interleukin-7 in Treating Patients With Metastatic Melanoma or Locally Advanced or Metastatic Kidney Cancer

DISEASE CHARACTERISTICS:

• Histologically confirmed diagnosis of 1 of the following:

  • Melanoma

    • Metastatic disease

  • Renal cell carcinoma

    • Locally advanced and unresectable disease OR metastatic disease
• Refractory to standard therapy OR ineligible to receive standard therapy
• Measurable or evaluable disease
• Previously received high-dose interleukin-2 OR have a contraindication for this treatment
• No previously untreated or unstable brain metastases
• No splenic metastasis

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2
• Life expectancy ≥ 3 months
• Absolute neutrophil count > 1,000/mm\^3
• Platelet count > 100,000/mm\^3
• PT/PTT ≤ 1.5 times upper limit of normal (ULN)
• Creatinine \< 1.5 times ULN
• AST and ALT \< 2.5 times ULN
• Conjugated (Direct) bilirubin ≤ 1.25 times ULN
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

• LVEF ≥ 45% by cardiac stress test (e.g., stress thallium, stress MUGA, dobutamine echocardiogram, or other stress test) for patients meeting any of the following criteria:

  • History of ECG abnormalities
  • Symptoms of cardiac ischemia
  • At least 50 years of age and over
  • Familial or personal history of heart failure
  • Previously treated with antimitotic agents susceptible to trigger heart failure
• FEV_1 > 60% of predicted (for patients with a prolonged smoking history or symptoms of respiratory dysfunction)
• No concurrent cognitive impairment or likelihood of developing cognitive impairment on study therapy
• No concurrent splenomegaly or proliferative hematologic disease
• No documented HIV positivity

• No acute hepatitis A or hepatitis B or C

  • Positive hepatitis B serology indicative of previous immunization (i.e., HBs Ab positive and HBc Ab negative) allowed
  • Positive hepatitis C serology allowed provided HCV RNA load by PCR is negative

• Resting blood pressure ≤ 140/90 mm Hg on standard antihypertensive therapy

  • Untreated hypertensive patients who received standard antihypertensive therapy allowed provided hypertension is well controlled
• No QTc prolongation ≥ 470 msec
• No prior history of cardiovascular disease, arrhythmias, or significant ECG abnormalities

• No active infection requiring systemic treatment and/or hospitalization within the past 28 days

  • Patients who have completed therapy or are clinically stable on therapy, in the opinion of the investigator, are eligible
• No history of autoimmune disease
• No history of severe asthma
• No history of medical or psychiatric disease that would preclude study treatment
• No documented cirrhosis or documented acute hepatitis

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• More than 2 weeks since prior systemic corticosteroid therapy
• More than 4 weeks since prior and no other concurrent cytotoxic therapy, immunotherapy, biological agents (i.e., cytokines, growth factors, or monoclonal antibodies), or antitumor vaccines
• More than 7 days since prior hepatotoxic drugs unless medically necessary
• More than 2 days since prior alcohol consumption
• More than 1 day since prior acetaminophen use
• No prior splenectomy
• No prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation
• No concurrent palliative therapy
• No concurrent chemotherapy

• No concurrent chronic anticoagulation (i.e., high-dose warfarin or heparin)

  • Warfarin dose 1 to 2 mg/day allowed
• No concurrent chronic medications for asthma
• No other concurrent investigational agents