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

This study has been completed.
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: May 14, 2004
Last updated: June 18, 2013
Last verified: December 2005

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 Intervention Phase
Kidney Cancer
Melanoma (Skin)
Biological: denileukin diftitox
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Evaluation of Denileukin Diftitox in Patients With Metastatic Melanoma or Metastatic Kidney Cancer

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Clinical response [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in levels of CD4-positive CD25-positive lymphocytes in the peripheral blood [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]

Study Start Date: March 2004
Study Completion Date: July 2006
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.


Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00082914

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)
Study Chair: Steven A. Rosenberg, MD, PhD NCI - Surgery Branch
  More Information Identifier: NCT00082914     History of Changes
Obsolete Identifiers: NCT00078702
Other Study ID Numbers: CDR0000361715  NCI-04-C-0134 
Study First Received: May 14, 2004
Last Updated: June 18, 2013
Health Authority: United States: Federal Government

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:
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
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs processed this record on October 28, 2016