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

Sponsor:	Loyola University
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00003126

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
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:

MedlinePlus related topics: Cancer Kidney Cancer

Drug Information available for: Aldesleukin

U.S. FDA Resources

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

Estimated Enrollment:	68
Study Start Date:	June 1997

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

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
Summit Medical Center
Oakland, California, United States, 94609
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90033-0804
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
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0752
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:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000065887, CWG-LU-8520, NCI-V97-1351
Study First Received:	November 1, 1999
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00003126 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage III renal cell cancer
stage IV renal cell cancer

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-HIV Agents
Neoplasms by Histologic Type
Antineoplastic Agents
Urogenital Neoplasms
Urologic Neoplasms
Antiviral Agents
Pharmacologic Actions
Carcinoma
Neoplasms

Neoplasms by Site
Aldesleukin
Anti-Retroviral Agents
Urologic Diseases
Kidney Neoplasms
Therapeutic Uses
Carcinoma, Renal Cell
Kidney Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009