Denileukin Diftitox in Treating Patients With Metastatic Melanoma or Metastatic Kidney Cancer

DISEASE CHARACTERISTICS:

• Diagnosis of 1 of the following:

  • Melanoma
  • Kidney cancer
• Metastatic disease
• Measurable disease
• Documented disease progression while receiving standard therapy
• No resectable local or regional disease

PATIENT CHARACTERISTICS:

Age

• 16 and over

Performance status

• ECOG 0-2

Life expectancy

• More than 3 months

Hematopoietic

• WBC ≥ 3,000/mm^3
• Platelet count ≥ 90,000/mm^3
• Lymphocyte count ≥ 500/mm^3
• No concurrent coagulation disorders

Hepatic

• Bilirubin ≤ 2.0 mg/dL (< 3.0 mg/dL for patients with Gilbert's syndrome)
• AST and ALT < 3 times normal
• Albumin ≥ 2.5 g/dL
• Hepatitis B surface antigen negative
• Hepatitis C antibody negative

Renal

• Creatinine ≤ 2.0 mg/dL

Cardiovascular

• Normal thallium stress test*
• No prior myocardial infarction
• No history of severe coronary artery disease
• No major medical illness of the cardiovascular system NOTE: *For patients > 50 years of age OR who have a history of cardiovascular disease

Pulmonary

• No major medical illness of the respiratory system

Immunologic

• HIV negative
• No active systemic infection
• No presence of opportunistic infections
• No primary or secondary immunodeficiency
• No autoimmune disease
• No other known immunodeficiency

Other

• No sensitivity to denileukin diftitox or any of its components (e.g., diphtheria toxin, interleukin-2, or excipients)
• Willing to undergo leukapheresis
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Prior treatment with interleukin-2 allowed provided the patient's disease status required this therapy

Chemotherapy

• Recovered from prior chemotherapy

Endocrine therapy

• No concurrent systemic steroids

Radiotherapy

• Recovered from prior radiotherapy

Surgery

• Not specified

Other

• More than 3 weeks since prior systemic anticancer therapy
• No other concurrent systemic anticancer therapy