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Monoclonal Antibody Therapy in Treating Patients With Metastatic Renal Cell Cancer

This study has been completed.
National Cancer Institute (NCI)
Information provided by:
National Institutes of Health Clinical Center (CC) Identifier:
First received: April 7, 2003
Last updated: March 14, 2012
Last verified: March 2012

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy in treating patients who have metastatic renal cell cancer (kidney cancer) that is refractory to treatment with interleukin-2 or unable to be treated with interleukin-2.

Condition Intervention Phase
Kidney Cancer
Biological: ipilimumab
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Open-Label Study of Single Agent MDX-010 for the Treatment of IL-2 Refractory or IL-2 Ineligible Patients With Stage IV Renal Cancer

Resource links provided by NLM:

Further study details as provided by National Institutes of Health Clinical Center (CC):

Study Start Date: February 2003
Study Completion Date: February 2008
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Detailed Description:


  • Determine the activity of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody in patients with metastatic clear cell renal cancer who are refractory to or ineligible for interleukin-2.
  • Determine the impact of this drug on T-cell number and phenotype in these patients.

OUTLINE: This is an open-label study.

Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody IV over 90 minutes once every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients with an ongoing partial response may receive additional courses of therapy.

Patients are followed at 4 weeks, every 3 months for 1 year, every 6 months for 2 years, and then annually until disease progression.

PROJECTED ACCRUAL: A total of 21-103 patients will be accrued for this study within 2-4 years.


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


  • Histologically confirmed stage IV clear cell renal carcinoma
  • At least 1 site of measurable disease
  • Meeting criteria for 1 of the following:

    • Disease progression after prior interleukin-2 (IL-2)
    • Ineligible for standard high-dose IV IL-2 due to comorbid medical conditions
    • Minimal disease (lesions ≤ 3 cm that do not pose risk to organ function) such that participation in this study is not likely to compromise the patient's opportunity to receive future high-dose IL-2
    • Indolent disease (defined as an increase in tumor size of < 50% within the past 6 months) such that participation in this study is not likely to compromise the patient's opportunity to receive future high-dose IL-2
    • No true papillary, medullary, chromophobe, collecting duct, or oncocytic renal cancer



  • 16 and over

Performance status

  • ECOG 0-1

Life expectancy

  • At least 3 months


  • WBC ≥ 2,500/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 10 g/dL
  • Hematocrit ≥ 30%


  • AST ≤ 3 times upper limit of normal (ULN)
  • Bilirubin ≤ ULN (< 3.0 mg/dL for patients with Gilbert's syndrome)
  • Hepatitis B surface antigen negative
  • Hepatitis C antibody negative


  • Creatinine < 2.0 mg/dL


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative
  • No other malignancy except adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or any other cancer from which the patient has been disease free for at least 5 years
  • No autoimmune disease (including uveitis and autoimmune inflammatory eye disease)
  • No active uncontrolled infection
  • No other medical condition that would preclude study participation


Biologic therapy

  • See Disease Characteristics
  • No prior anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody
  • At least 3 weeks since prior immunotherapy for renal cancer


  • At least 3 weeks since prior chemotherapy for renal cancer
  • No concurrent chemotherapy

Endocrine therapy

  • At least 3 weeks since prior hormonal therapy for renal cancer
  • More than 4 weeks since prior corticosteroids
  • No concurrent systemic or topical corticosteroids


  • At least 3 weeks since prior radiotherapy for renal cancer


  • Not specified


  • Recovered from prior therapy
  • At least 3 weeks since other prior therapy for renal cancer
  • No concurrent immunosuppressive agents (e.g., cyclosporine and its analog)
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Please refer to this study by its identifier: NCT00057889

United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
National Cancer Institute (NCI)
Study Chair: James C. Yang, MD NCI - Surgery Branch
  More Information Identifier: NCT00057889     History of Changes
Obsolete Identifiers: NCT00053729
Other Study ID Numbers: 030094
Study First Received: April 7, 2003
Last Updated: March 14, 2012

Keywords provided by National Institutes of Health Clinical Center (CC):
clear cell renal cell carcinoma
stage IV renal cell cancer
recurrent renal cell cancer

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases processed this record on May 23, 2017