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Interleukin-2 in Treating Patients With Stage III or Stage IV Kidney Cancer

This study has been completed.
Sponsor:
Collaborator:
Chiron Corporation
Information provided by (Responsible Party):
Loyola University
ClinicalTrials.gov Identifier:
NCT00003126
First received: November 1, 1999
Last updated: January 2, 2017
Last verified: January 2017
  Purpose
The purpose of this study is to assess the efficacy of post-operative high-dose bolus interleukin-2 (IL-2) in patients with high-risk renal cell carcinoma (RCC).

Condition Intervention Phase
Kidney Cancer
Drug: Interleukin-2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Phase III Adjuvant Trial of High-Dose Bolus IL-2 in Patients With High-Risk Renal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by Loyola University:

Primary Outcome Measures:
  • Disease free survival [ Time Frame: 60 months ]
    Disease free survival will be compared between the two cohorts (i.e., IL-2 versus Observation). Time will be calculated as the difference in months from date of treatment to date of death or recurrence (whichever occurs first). Patients remaining disease-free will be censored at the date of last follow-up.


Secondary Outcome Measures:
  • Overall survival [ Time Frame: 60 months ]
    Overall survival will be compared between the two cohorts (i.e., IL-2 versus Observation). Time will be calculated as the difference in months from date of treatment to date of death. Living patients will be censored at the date of last follow-up.


Enrollment: 69
Study Start Date: June 1997
Study Completion Date: August 2002
Primary Completion Date: August 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Interleukin-2 (IL-2)
Patients randomized to this arm will receive one course of IL-2 [600,000 U/kg every 8 hours on post-operative days 1 to 5 and days 15 to 19 (maximum 28 doses)].
Drug: Interleukin-2
High-dose bolus interleukin-2 is a systemic therapy used to treat metastatic RCC
Other Names:
  • IL-2
  • Aldesleukin
No Intervention: Observation
Patients randomized to this arm will receive their normal medical care

Detailed Description:

The primary objective of this prospective, randomized, controlled trial is to compare the disease-free and overall survival of patients with stage III or IV high-risk renal cell carcinoma (RCC) who were treated with adjuvant high-dose interleukin-2 vs observation alone.

Patients are stratified according to their disease classification and randomized to one course of IL-2 [600,000 U/kg every 8 hours on days 1 to 5 and days 15 to 19 (maximum 28 doses)] or observation.

  Eligibility

Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Adequate organ function as defined by a white blood cell (WBC) count of 4,000/L; a platelet count of 100,000/L; a Hemoglobin level of 10 g/dL; a serum creatinine of 1.5 mg/dL or creatinine clearance of 60 mL/min; and a direct bilirubin level of 1.5 mg/dL.
  • Forced expiratory volume at 1 second more than 2.0 L or 75% of predicted for height and age from pre-enrollment pulmonary function testing.
  • No history or evidence of cardiac disease on ECG
  • No prior systemic treatment for RCC, but patients may have received prior locoregional radiation therapy to solitary resectable metastases, which must have undergone surgical resection before enrollment.
  • No prior history of invasive malignancy in the past 5 years
  • Human immunodeficiency virus (HIV) negative
  • Female patients must not be pregnant or planning to become pregnant

Exclusion criteria

• Age younger than 16

  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: NCT00003126

Locations
United States, California
Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, United States, 91010-3000
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90033-0804
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
Summit Medical Center
Oakland, California, United States, 94609
United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5289
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0752
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
United States, New Hampshire
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756-0002
United States, New York
Our Lady of Mercy Medical Center
Bronx, New York, United States, 10466
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28232-2861
United States, Oregon
Earle A. Chiles Research Institute at Providence Portland Medical Center
Portland, Oregon, United States, 97213-2967
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
United States, Texas
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78284-7811
Sponsors and Collaborators
Loyola University
Chiron Corporation
Investigators
Principal Investigator: Joseph I. Clark, MD Loyola University
  More Information

Publications:

Responsible Party: Loyola University
ClinicalTrials.gov Identifier: NCT00003126     History of Changes
Other Study ID Numbers: 852006
Study First Received: November 1, 1999
Last Updated: January 2, 2017
Individual Participant Data  
Plan to Share IPD: No
Plan Description: There is no plan to share individual participant data

Keywords provided by Loyola University:
renal cell cancer
renal cell carcinoma
interleukin-2

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
Interleukin-2
Antineoplastic Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 21, 2017