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Interleukin-2 in Treating Patients With Metastatic Kidney Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00018941
First Posted: May 5, 2003
Last Update Posted: June 17, 2013
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.
Information provided by:
National Cancer Institute (NCI)
  Purpose

RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. It is not yet known which regimen of interleukin-2 is most effective for kidney cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of interleukin-2 in treating patients who have metastatic kidney cancer.


Condition Intervention Phase
Kidney Cancer Biological: aldesleukin Phase 3

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase III Randomized Study of Intravenous Low Dose Versus Intravenous High Dose Versus Subcutaneous Interleukin-2 for Metastatic Renal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: April 1991
Study Completion Date: May 2003
Detailed Description:

OBJECTIVES: I. Determine the response rate and overall survival of patients with metastatic renal cell carcinoma treated with either low-dose or high-dose intravenous interleukin-2 (IL-2) or subcutaneous IL-2. II. Compare the toxic effects of these 3 regimens in this patient population.

OUTLINE: This is a randomized study. Patients are stratified according to presence of renal tumor (yes vs no). Patients are randomized to one of three treatment arms. Arm I: Patients receive low dose interleukin-2 (IL-2) IV every 8 hours for up to 15 doses. Treatment repeats in 7-10 days for one complete course. Arm II: Patients receive high dose IL-2 IV every 8 hours for up to 15 doses. Treatment repeats in 7-10 days for one complete course. Arm III: Patients receive IL-2 subcutaneously daily 5 days a week for 6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease receive an additional complete course of therapy.

PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.

  Eligibility

Information from the National Library of Medicine

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

DISEASE CHARACTERISTICS: Histologically proven, metastatic renal cell carcinoma with measurable disease No more than 25% of liver replaced with tumor No CNS involvement or major nerve compression allowed

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: More than 3 months Hematopoietic: Not specified Hepatic: Bilirubin less than 2.0 mg/dL AST and ALT no greater than 3 times normal Renal: Creatinine less than 1.6 mg/dL Cardiovascular: Normal EKG Normal thallium stress test (required of patients 50 years of age and older or as clinically indicated) Pulmonary: FEV1 and VC greater than 65% of predicted (pulmonary function screening required of patients with significant smoking history or suspicion of pulmonary disease) Other: No second malignancy, except: Basal cell skin cancer Carcinoma in situ of the cervix No significant psychiatric disease that would preclude consent or treatment No systemic infection No coagulation disorders or bleeding Not pregnant HIV negative

PRIOR CONCURRENT THERAPY: No prior therapy within 28 days Biologic therapy: No prior interleukin-2 Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No concurrent steroids

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00018941


Locations
United States, Maryland
Surgery Branch
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Study Chair: James C. Yang, MD NCI - Surgery Branch
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00018941     History of Changes
Obsolete Identifiers: NCT00001268
Other Study ID Numbers: CDR0000076799
NCI-91-C-0094
NCI-T91-0053N
First Submitted: July 11, 2001
First Posted: May 5, 2003
Last Update Posted: June 17, 2013
Last Verified: March 2003

Keywords provided by National Cancer Institute (NCI):
stage IV renal cell cancer
recurrent renal cell cancer

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