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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase II Evaluation of Denileukin Diftitox in Patients With Metastatic Melanoma or Metastatic Kidney Cancer

Conditions
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Kidney Cancer, Melanoma (Skin)

Intervention / Treatment
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* Biological: denileukin diftitox


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: denileukin diftitox|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in levels of CD4-positive CD25-positive lymphocytes in the peripheral blood |  |  | 
| Toxicity |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent renal cell cancer, stage IV renal cell cancer, recurrent melanoma, stage IV melanoma