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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00082914
Recruitment Status : Completed
First Posted : May 19, 2004
Last Update Posted : June 20, 2013
Information provided by:
National Cancer Institute (NCI)

Brief 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.

Condition or disease Intervention/treatment Phase
Kidney Cancer Melanoma (Skin) Biological: denileukin diftitox Phase 2

Detailed Description:



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


  • 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.

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Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Evaluation of Denileukin Diftitox in Patients With Metastatic Melanoma or Metastatic Kidney Cancer
Study Start Date : March 2004
Actual Study Completion Date : July 2006

Primary Outcome Measures :
  1. Clinical response

Secondary Outcome Measures :
  1. Changes in levels of CD4-positive CD25-positive lymphocytes in the peripheral blood
  2. Toxicity

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 16 and over

Performance status

  • ECOG 0-2

Life expectancy

  • More than 3 months


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


  • 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


  • Creatinine ≤ 2.0 mg/dL


  • 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


  • No major medical illness of the respiratory system


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


  • 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


Biologic therapy

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


  • Recovered from prior chemotherapy

Endocrine therapy

  • No concurrent systemic steroids


  • Recovered from prior radiotherapy


  • Not specified


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00082914

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United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
NCI - Center for Cancer Research
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
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Study Chair: Steven A. Rosenberg, MD, PhD NCI - Surgery Branch
Layout table for additonal information Identifier: NCT00082914    
Obsolete Identifiers: NCT00078702
Other Study ID Numbers: CDR0000361715
First Posted: May 19, 2004    Key Record Dates
Last Update Posted: June 20, 2013
Last Verified: December 2005
Keywords provided by National Cancer Institute (NCI):
recurrent renal cell cancer
stage IV renal cell cancer
recurrent melanoma
stage IV melanoma
Additional relevant MeSH terms:
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Kidney Neoplasms
Carcinoma, Renal Cell
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplasms, Glandular and Epithelial
Denileukin diftitox
Antineoplastic Agents