Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	16 and over	NCI	NCI-04-C-0134 NCT00082914

Objectives

Primary

1. Determine the clinical response in patients with metastatic melanoma or metastatic kidney cancer treated with denileukin diftitox.

Secondary

1. 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.
2. Determine the toxicity profile of this drug in these patients.

Entry 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

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

Patient Characteristics:

Age

• 16 and over

Performance status

• ECOG 0-2

Life expectancy

• More than 3 months

Hematopoietic

• WBC ≥ 3,000/mm³
• Platelet count ≥ 90,000/mm³
• Lymphocyte count ≥ 500/mm³
• 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

Expected Enrollment

A total of 10-96 patients (5-48 per stratum) will be accrued for this study within 3-4 years.

Outcomes

Clinical response

Changes in levels of CD4-positive CD25-positive lymphocytes in the peripheral blood
Toxicity

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.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

Steven Rosenberg, MD, PhD, Protocol chair		Ph: 866-820-4505 Email: sar@nih.gov

Registry Information
Official Title		Phase II Evaluation of Denileukin Diftitox in Patients With Metastatic Melanoma or Metastatic Kidney Cancer
Trial Start Date		2004-03-11
Registered in ClinicalTrials.gov		NCT00082914
Date Submitted to PDQ		2004-03-11
Information Last Verified		2005-12-20

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