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Interleukin-2 in Treating Patients With Metastatic Kidney Cancer

This study has been completed.
Sponsor:
Collaborators:
Chiron Corporation
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00006864
First received: December 6, 2000
Last updated: January 8, 2014
Last verified: January 2014

December 6, 2000
January 8, 2014
July 2000
July 2007   (final data collection date for primary outcome measure)
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Not Provided
Complete list of historical versions of study NCT00006864 on ClinicalTrials.gov 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.

OBJECTIVES:

  • 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.

Interventional
Phase 4
Primary Purpose: Treatment
Kidney Cancer
Biological: aldesleukin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
July 2007
July 2007   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • Not specified

Hematopoietic:

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

Hepatic:

  • Not specified

Renal:

  • Creatinine no greater than 1.8 mg/dL

Cardiovascular:

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

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

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

Chemotherapy:

  • 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

Radiotherapy:

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

Surgery:

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

Other:

  • 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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006864
CHIR1899, CWRU-CHIR-1899, CHIR-MA-99-01, CWRU-010002, NCI-G00-1875
Yes
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