Interleukin-2 in Treating Patients With Stage III or Stage IV Kidney Cancer
This study has been completed.
Sponsor:
Loyola University
Information provided by:
Loyola University
ClinicalTrials.gov Identifier:
NCT00003126
First received: November 1, 1999
Last updated: August 16, 2010
Last verified: August 2010
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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) |
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 | |
| 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 Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site |
Kidney Diseases Urologic Diseases Aldesleukin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on May 21, 2013