Know Cancer

or
forgot password

A Randomized Controlled Phase III Adjuvant Trial of High-Dose Bolus IL-2 in Patients With High-Risk Renal Cell Carcinoma


Phase 3
16 Years
N/A
Not Enrolling
Both
Kidney Cancer

Thank you

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