ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Denileukin Diftitox in Treating Patients With Metastatic Melanoma or Metastatic Kidney Cancer

This study has been completed.

Sponsors and Collaborators: NCI - Center for Cancer Research-Medical Oncology
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00082914
  Purpose

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)
Drug: denileukin diftitox
Phase II

MedlinePlus related topics:   Cancer    Kidney Cancer    Melanoma   

Drug Information available for:   Denileukin diftitox   

U.S. FDA Resources

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

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

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.

  Eligibility
Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00082914

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

Sponsors and Collaborators
NCI - Center for Cancer Research-Medical Oncology
National Cancer Institute (NCI)

Investigators
Study Chair:     Steven A. Rosenberg, MD, PhD     NCI - Surgery Branch    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000361715, NCI-04-C-0134
First Received:   May 14, 2004
Last Updated:   October 18, 2008
ClinicalTrials.gov Identifier:   NCT00082914
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  

Study placed in the following topic categories:
Urogenital Neoplasms
Renal cancer
Kidney cancer
Urologic Neoplasms
Recurrence
Melanoma
Carcinoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Urologic Diseases
Interleukin-2
Kidney Neoplasms
Denileukin diftitox
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Carcinoma, Renal Cell
Neuroepithelioma
Nevus
Kidney Diseases
Adenocarcinoma
Urinary tract neoplasm
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Antineoplastic Agents
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Nevi and Melanomas
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 30, 2008




Links to all studies - primarily for crawlers