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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

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Kidney Cancer Biological: aldesleukin Phase 4

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Interleukin-2 In An Alternative Dose (The Iliad Trial): Treatment Of Patients With Metastatic Renal Cell Carcinoma With Low Dose Proleukin
Study Start Date : July 2000
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00006864

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United States, Connecticut
Northwestern Connecticut Oncology-Hematology Associates
Torrington, Connecticut, United States, 06790
United States, Ohio
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5065
Sponsors and Collaborators
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Chiron Corporation
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Study Chair: Cindy Connell, MD, PhD University Hospitals Seidman Cancer Center

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Responsible Party: Case Comprehensive Cancer Center Identifier: NCT00006864     History of Changes
Other Study ID Numbers: CHIR1899
First Posted: June 2, 2003    Key Record Dates
Last Update Posted: January 9, 2014
Last Verified: January 2014
Keywords provided by Case Comprehensive Cancer Center:
stage IV renal cell cancer
recurrent renal cell cancer
clear cell renal cell carcinoma
Additional relevant MeSH terms:
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Kidney Neoplasms
Carcinoma, Renal Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents