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
  Purpose

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 Intervention Phase
Kidney Cancer
Biological: aldesleukin
Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Study Start Date: July 2000
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006864

Locations
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
Chiron Corporation
Investigators
Study Chair: Cindy Connell, MD, PhD University Hospitals Seidman Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00006864     History of Changes
Other Study ID Numbers: CHIR1899, CWRU-CHIR-1899, CHIR-MA-99-01, CWRU-010002, NCI-G00-1875
Study First Received: December 6, 2000
Last Updated: January 8, 2014
Health Authority: United States: Federal Government

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:
Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Aldesleukin
Interleukin-2
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on April 23, 2014