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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2000 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003604
First received: November 1, 1999
Last updated: November 5, 2013
Last verified: September 2000
  Purpose

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.


Condition Intervention Phase
Kidney Cancer
Biological: aldesleukin
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Multi-Center Adjuvant Trial of Outpatient Moderate-Dose Bolus Interleukin-2 for Renal Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 20
Study Start Date: October 1997
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003604

Locations
United States, Indiana
Cancer Care Center for Southern Indiana
Bloomington, Indiana, United States, 47403
United States, Nebraska
Bergan Mercy Medical Center
Omaha, Nebraska, United States, 68124
United States, Tennessee
Baptist Regional Cancer Center - Knoxville
Knoxville, Tennessee, United States, 37901
Sponsors and Collaborators
Cancer Biotherapy Research Group
Investigators
Study Chair: Datchen F. Tai, MD Cancer Biotherapy Research Group
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00003604     History of Changes
Other Study ID Numbers: CDR0000066679, CBRG-9704, NBSG-9704, NCI-V98-1482
Study First Received: November 1, 1999
Last Updated: November 5, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III renal cell cancer
stage IV renal cell cancer

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Aldesleukin
Interleukin-2
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on August 20, 2014