Interleukin-2 in Treating Patients With Stage III or Stage IV Kidney Cancer That Has Been Removed With Surgery

Kidney Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00003604
• Other study ID #: CDR0000066679
• Secondary ID: CBRG-9704NBSG-97
• Status: Active, not recruiting
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: November 5, 2013
• Start date: October 1997

Study information

• Verified date: September 2000
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill kidney cancer cells.

PURPOSE: Phase II trial to study the effectiveness of interleukin-2 in treating patients with stage III or stage IV kidney cancer that has been removed by surgery.

Description:

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 death.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms

Intervention

Biological:
• aldesleukin

Locations

Country	Name	City	State
United States	Cancer Care Center for Southern Indiana	Bloomington	Indiana
United States	Baptist Regional Cancer Center - Knoxville	Knoxville	Tennessee
United States	Bergan Mercy Medical Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Biotherapy Research Group

Country where clinical trial is conducted

United States,