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

Phase 3

Completed

• Conditions: Kidney Cancer
• Interventions: Drug: Interleukin-2

• Registration Number: NCT00003126
• Lead Sponsor: Loyola University

Brief Summary

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).

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 Timeline

• Study Start: 1997-06
• Study First Submitted: 1999-11-01
• Primary Completion: 2002-08
• Study Completion: 2002-08
• Study First Submitted QC: 2003-10-27
• Study First Posted: 2003-10-28
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-02
• Last Update Posted: 2017-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interleukin-2 (IL-2)	Interleukin-2	Patients randomized to this arm will receive one course of IL-2 \[600,000 U/kg every 8 hours on post-operative days 1 to 5 and days 15 to 19 (maximum 28 doses)\].

Primary Outcome Measures

Name	Time	Method
Disease free survival	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

Name	Time	Method
Overall survival	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.

Trial Locations

Locations (15)

Norris Cotton Cancer Center; 🇺🇸 Lebanon, New Hampshire, United States

Indiana University Cancer Center; 🇺🇸 Indianapolis, Indiana, United States

Summit Medical Center; 🇺🇸 Oakland, California, United States

Carolinas Medical Center; 🇺🇸 Charlotte, North Carolina, United States

Our Lady of Mercy Medical Center; 🇺🇸 Bronx, New York, United States

USC/Norris Comprehensive Cancer Center and Hospital; 🇺🇸 Los Angeles, California, United States

Jonsson Comprehensive Cancer Center, UCLA; 🇺🇸 Los Angeles, California, United States

Loyola University Medical Center; 🇺🇸 Maywood, Illinois, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Earle A. Chiles Research Institute at Providence Portland Medical Center; 🇺🇸 Portland, Oregon, United States

University of Texas Health Science Center at San Antonio; 🇺🇸 San Antonio, Texas, United States

Barbara Ann Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States

Vanderbilt-Ingram Cancer Center; 🇺🇸 Nashville, Tennessee, United States

University of Michigan Comprehensive Cancer Center; 🇺🇸 Ann Arbor, Michigan, United States

Cancer Center and Beckman Research Institute, City of Hope; 🇺🇸 Duarte, California, United States