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

January 2, 2017 updated by: Loyola University

A Randomized Controlled Phase III Adjuvant Trial of High-Dose Bolus IL-2 in Patients With High-Risk Renal Cell Carcinoma

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • Aldesleukin
  • IL-2
No Intervention: Observation
Patients randomized to this arm will receive their normal medical care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
60 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loyola University

Collaborators

Chiron Corporation

Investigators

  • Principal Investigator: Joseph I. Clark, MD, Loyola University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 1997

Primary Completion (Actual)

August 1, 2002

Study Completion (Actual)

August 1, 2002

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

October 27, 2003

First Posted (Estimate)

October 28, 2003

Study Record Updates

Last Update Posted (Estimate)

January 4, 2017

Last Update Submitted That Met QC Criteria

January 2, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 852006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

There is no plan to share individual participant data

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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