Denileukin Diftitox in Treating Patients With Metastatic Melanoma or Metastatic Kidney Cancer
Kidney Cancer, Melanoma (Skin)
About this trial
This is an interventional treatment trial for Kidney Cancer focused on measuring recurrent renal cell cancer, stage IV renal cell cancer, recurrent melanoma, stage IV melanoma
Eligibility Criteria
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
Sites / Locations
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
- NCI - Center for Cancer Research