Interleukin-2 in Treating Patients With Metastatic Kidney Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00006864
Recruitment Status : Completed
First Posted : June 2, 2003
Last Update Posted : January 9, 2014
National Cancer Institute (NCI)
Chiron Corporation
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

December 6, 2000
June 2, 2003
January 9, 2014
July 2000
July 2007   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00006864 on Archive Site
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Interleukin-2 in Treating Patients With Metastatic Kidney Cancer
Interleukin-2 In An Alternative Dose (The Iliad Trial): Treatment Of Patients With Metastatic Renal Cell Carcinoma With Low Dose Proleukin

RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill kidney cancer cells.

PURPOSE: Phase IV trial to study the effectiveness of interleukin-2 in treating patients who have metastatic kidney cancer.


  • Determine the overall response rate, complete and partial response rates, and duration of response in patients with metastatic renal cell carcinoma treated with low-dose interleukin-2.
  • Determine the overall survival, one-year progression-free survival, and two-year progression-free survival in patients treated with this regimen.
  • Determine the incidence of adverse events in these patients.

OUTLINE: This is a multicenter study.

Patients receive low-dose interleukin-2 subcutaneously 5 days a week for 6 weeks. Courses repeat every 9 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years.

PROJECTED ACCRUAL: A total of 464 patients will be accrued for this study.

Phase 4
Primary Purpose: Treatment
Kidney Cancer
Biological: aldesleukin
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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July 2007
July 2007   (Final data collection date for primary outcome measure)


  • Histologically proven metastatic renal cell carcinoma

    • Clear cell
    • Papillary
    • Sarcomatoid
    • Mixed
  • Measurable or evaluable disease
  • Evidence of disease following surgical resection of metastases
  • No CNS disease



  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • Not specified


  • Hemoglobin at least 10 g/dL
  • WBC at least 4,000/mm3
  • Platelet count at least 100,000/mm3


  • Not specified


  • Creatinine no greater than 1.8 mg/dL


  • No New York Heart Association class III or IV heart disease


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception (barrier plus 1 other method)
  • Thyroid-stimulating hormone normal
  • No known hypersensitivity or allergy to components of recombinant human interleukin-2
  • No known autoimmune disease (e.g., Crohn's disease)
  • No other concurrent medical condition that would preclude study


Biologic therapy:

  • No prior recombinant human interleukin-2
  • No concurrent interferon alfa


  • No concurrent cytoxic chemotherapy

Endocrine therapy:

  • No concurrent hormonal therapy (e.g., medroxyprogesterone) other than estrogen replacement therapy
  • No concurrent prophylactic glucocorticoids (replacement doses and topical use allowed)
  • No concurrent systemic corticosteroids


  • At least 4 weeks since prior radiotherapy
  • No prior radiotherapy to index lesion
  • No concurrent radiotherapy


  • See Disease Characteristics
  • Prior surgery for renal cell carcinoma allowed


  • No prior systemic therapy for renal cell carcinoma
  • At least 4 weeks since prior investigational drugs
  • No other concurrent investigational drugs or participation in another clinical study
  • No concurrent iodinated radiocontrast dye
  • No concurrent drugs for another indication that has purported activity in treatment of neoplasia (e.g., thalidomide)
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
  • National Cancer Institute (NCI)
  • Chiron Corporation
Study Chair: Cindy Connell, MD, PhD University Hospitals Seidman Cancer Center
Case Comprehensive Cancer Center
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP