denileukin diftitox in treating patients with metastatic melanoma or metastatic kidney cancer

Conditions: Kidney Cancer; Melanoma (Skin)

Summary: rationale: denileukin diftitox may be able to make the body build an immune response to kill tumor cells. purpose: this phase ii trial is studying how well denileukin diftitox works in treating patients with metastatic melanoma or metastatic kidney cancer.

objectives: primary * determine the clinical response in patients with metastatic melanoma or metastatic kidney cancer treated with denileukin diftitox. secondary * determine whether changes occur in levels of cd4-positive cd25-positive lymphocytes in the peripheral blood of these patients before and after treatment with this drug. * determine the toxicity profile of this drug in these patients. outline: patients are stratified according to disease type (metastatic melanoma vs metastatic kidney cancer). patients receive denileukin diftitox iv over 1 hour on days 1-5, 21-25, 42-46, and 63-67. treatment repeats every 84 days (12 weeks) for up to a maximum total of 5 courses in the absence of disease progression, autoimmune ocular toxicity attributable to denileukin diftitox, or any other unacceptable toxicity. at any time during therapy, patients achieving a complete response receive 1 additional course of therapy after the complete response. projected accrual: a total of 10-96 patients (5-48 per stratum) will be accrued for this study within 3-4 years.

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

Keywords: recurrent renal cell cancer stage iv renal cell cancer recurrent melanoma stage iv melanoma