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

This is an interventional treatment trial for Kidney Cancer focused on measuring recurrent renal cell cancer, stage IV renal cell cancer, stage III renal cell cancer, recurrent melanoma, stage IV melanoma Read More

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