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A Multi-Center Adjuvant Trial of Outpatient Moderate-Dose Bolus Interleukin-2 for Renal Cancer

Phase 2
Open (Enrolling)
Kidney Cancer

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Trial Information

A Multi-Center Adjuvant Trial of Outpatient Moderate-Dose Bolus Interleukin-2 for Renal Cancer

OBJECTIVES: I. Determine the disease free survival and overall survival of patients with
resected stage III or IV renal cancer treated with interleukin-2. II. Measure the degree of
rebound lymphocytosis generated by this regimen in these patients.

OUTLINE: This is an open label study. Patients receive interleukin-2 IV over 15-30 minutes
on 3 consecutive days weekly for 6 weeks, followed by 2 weeks of rest. Patients receive 2
treatment courses, each 8 weeks in duration. Patients are followed every 6 months until

PROJECTED ACCRUAL: A total of 20 patients will be accrued within 1 to 2 years.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven stage III or IV renal cancer that has been
completely resected and is at high risk for recurrence, including at least one of the
following: Tumor invades adrenal gland or perinephric tissues but not beyond Gerota's
fascia (T3a) OR Tumor extending into renal vein, vena cava (T3b) OR Tumor grossly extends
into vena cava above diaphragm (T3c) OR Tumor invades beyond Gerota's fascia (T4) OR Any
lymph node involvement totally resected (N1-3) OR Completely resected metastases of all
sites No brain metastases

PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Life expectancy:
Not specified Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3
Hemoglobin at least 9 g/dL Hepatic: Bilirubin less than 3 times upper limit of normal
(ULN) AST or ALT less than 3 times ULN Renal: Creatinine no greater than 1.9 mg/dL
Cardiovascular: No prior myocardial infarction within 6 months No LVEF less than 35% No
primary cardiac arrhythmias beyond occasional PVCs No angina No uncontrolled congestive
heart failure No cerebrovascular accident Pulmonary: No dyspnea at rest or requirement for
supplemental oxygen Oxygen saturation greater than 90% for patients with symptomatic lung
disease Other: Not pregnant or nursing Negative pregnancy test Fetile patients must use
effective contraception Temperatures greater than 100.5 degrees F must have occult
infection excluded No psychiatric disorders

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No concurrent
cyclosporine or methotrexate Endocrine therapy: At least 3 weeks since prior
corticosteroids No concurrent corticosteroids Radiotherapy: Not specified Surgery: At
least 2 weeks since prior surgery Other: At least 3 weeks since prior immunosuppressive
medications No concurrent immunosuppressive medications

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Datchen F. Tai, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Cancer Biotherapy Research Group


United States: Federal Government

Study ID:




Start Date:

October 1997

Completion Date:

Related Keywords:

  • Kidney Cancer
  • stage III renal cell cancer
  • stage IV renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms



Bergan Mercy Medical Center Omaha, Nebraska  68124
Baptist Regional Cancer Center - Knoxville Knoxville, Tennessee  37901
Cancer Care Center for Southern Indiana Bloomington, Indiana  47403