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Status:

COMPLETED

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

Lead Sponsor:

National Cancer Institute (NCI)

Conditions:

Kidney Cancer

Melanoma (Skin)

Eligibility:

All Genders

16+ years

Phase:

PHASE2

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 patie...

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...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    March 1 2004

    Trial Type :

    INTERVENTIONAL

    End Date :

    July 1 2006

    Estimated Enrollment :

    Patients enrolled

    Trial Details

    Trial ID

    NCT00082914

    Start Date

    March 1 2004

    End Date

    July 1 2006

    Last Update

    June 20 2013

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

    Bethesda, Maryland, United States, 20892-1182

    2

    NCI - Center for Cancer Research

    Bethesda, Maryland, United States, 20892