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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014