A Randomized Controlled Phase III Adjuvant Trial of High-Dose Bolus IL-2 in Patients With High-Risk Renal Cell Carcinoma
16 Years
N/A
Both
Kidney Cancer
Trial Information
A Randomized Controlled Phase III Adjuvant Trial of High-Dose Bolus IL-2 in Patients With High-Risk Renal Cell Carcinoma
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
Joseph I. Clark, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Loyola University
Authority:
United States: Federal Government
Study ID:
CDR0000065887
NCT ID:
NCT00003126
Start Date:
June 1997
Completion Date:
August 2002
Related Keywords:
- Kidney Cancer
- stage III renal cell cancer
- stage IV renal cell cancer
- Carcinoma, Renal Cell
- Kidney Neoplasms
Name | Location |
|---|---|
| University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
| Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
| Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
| Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
| University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
| Norris Cotton Cancer Center | Lebanon, New Hampshire 03756 |
| Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
| Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
| Loyola University Medical Center | Maywood, Illinois 60153 |
| Cancer Center and Beckman Research Institute, City of Hope | Duarte, California 91010-3000 |
| USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
| Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
| Summit Medical Center | Oakland, California 94609 |
| Our Lady of Mercy Medical Center | Bronx, New York 10466 |
| Earle A. Chiles Research Institute at Providence Portland Medical Center | Portland, Oregon 97213-2967 |
