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

This study has been completed.
Sponsor:
Information provided by:
Loyola University
ClinicalTrials.gov Identifier:
NCT00003126
First received: November 1, 1999
Last updated: August 16, 2010
Last verified: August 2010
  Purpose

RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill kidney cancer cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of interleukin-2 with no further therapy in treating patients with stage III or stage IV kidney cancer.


Condition Intervention Phase
Kidney Cancer
Biological: aldesleukin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
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:

Estimated Enrollment: 68
Study Start Date: June 1997
Study Completion Date: August 2002
Primary Completion Date: August 2002 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Compare the disease-free and overall survival of patients with stage III or IV high-risk renal cell carcinoma treated with adjuvant high-dose interleukin-2 vs observation alone.
  • Determine the overall tolerability, toxicity, and safety of adjuvant high-dose interleukin-2 in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease classification (T3b (N0) or N1 (T1-3b) vs T3c or T4 (N0-1) vs N2 or N3 disease (T1-4) vs M1 disease resected to no evaluable disease). Within 3-12 weeks after radical nephrectomy and/or resection of metastases, patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive high-dose interleukin-2 IV over 15 minutes every 8 hours on days 1-5 and 15-19 for a maximum of 28 doses.
  • Arm II: Patients undergo observation alone. Patients may receive treatment as in arm I beginning at the first sign of recurrence.

Patients are followed every 3 months for 2 years, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 68 patients will be accrued for this study within 3 years.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically proven high-risk renal cell carcinoma that has been completely resected within the past 12 weeks

    • T3b (N0); N1 (T1-3b); T3c or T4 (N0-1); N2 or N3 (T1-4) disease OR
    • M1 disease resected to no evaluable disease
  • Postoperative radiographic evaluation must reveal no evidence of detectable residual disease
  • No ascites or pleural effusions
  • No detectable metastases

PATIENT CHARACTERISTICS:

Age

  • 16 and over

Performance status

  • ECOG 0-1 OR
  • Karnofsky 80-100%

Life expectancy

  • Not specified

Hematopoietic

  • WBC at least 4,000/mm3
  • Platelet count at least 100,000/mm3
  • Hemoglobin at least 10 g/dL

Hepatic

  • Bilirubin no greater than 1.5 mg/dL

Renal

  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance at least 60 mL/min

Cardiovascular

  • No congestive heart failure
  • No symptoms of coronary artery disease
  • No serious cardiac arrhythmias
  • No prior myocardial infarction
  • Normal cardiac stress test required if over age 40

Pulmonary

  • FEV1 greater than 2.0 liters or at least 75% predicted for height and age
  • No chronic obstructive pulmonary disease

Other

  • HIV negative
  • No significant detectable infection
  • No other significant medical disease
  • No other invasive malignancy within the past 5 years except surgically cured nonmelanomatous skin cancer or carcinoma in situ or stage I carcinoma of the cervix
  • No contraindication to pressor agents
  • No seizure disorder
  • No psychiatric illness that would preclude informed consent
  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior interleukin-2 for renal cell carcinoma

Chemotherapy

  • No prior systemic chemotherapy for renal cell carcinoma

Endocrine therapy

  • No concurrent steroids

Radiotherapy

  • Prior locoregional radiotherapy to solitary resectable metastases allowed

Surgery

  • See Disease Characteristics
  • Recovered from prior surgical resection
  • No prior organ allografts

Other

  • No other prior systemic therapy for renal cell carcinoma
  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
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90033-0804
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
Investigators
Study Chair: Joseph I. Clark, MD Loyola University
  More Information

Additional Information:
No publications provided

Responsible Party: Joseph Clark, Loyola University Medical Center
ClinicalTrials.gov Identifier: NCT00003126     History of Changes
Other Study ID Numbers: CDR0000065887, CWG-LU-8520, NCI-V97-1351
Study First Received: November 1, 1999
Last Updated: August 16, 2010
Health Authority: United States: Federal Government

Keywords provided by Loyola University:
stage III renal cell cancer
stage IV renal cell cancer

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Kidney Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014