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

June 18, 2013 updated by: National Cancer Institute (NCI)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892-1182
        • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
      • Bethesda, Maryland, United States, 20892
        • NCI - Center for Cancer Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Clinical response

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Study Completion (Actual)

July 1, 2006

Study Registration Dates

First Submitted

May 14, 2004

First Submitted That Met QC Criteria

May 18, 2004

First Posted (Estimate)

May 19, 2004

Study Record Updates

Last Update Posted (Estimate)

June 20, 2013

Last Update Submitted That Met QC Criteria

June 18, 2013

Last Verified

December 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000361715
  • NCI-04-C-0134

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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