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

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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00003604
Enrollment
20
Registered
2004-07-16
Start date
1997-10-31
Completion date
Unknown
Last updated
2013-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Cancer

Keywords

stage III renal cell cancer, stage IV renal cell cancer

Brief 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.

Detailed 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.

Interventions

BIOLOGICALaldesleukin

Sponsors

Cancer Biotherapy Research Group
Lead SponsorOTHER

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026