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

Inclusion Criteria

• •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