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

NCT ID: NCT00003604

Last Updated: 2013-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-10-31

Brief Summary

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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

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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.

Conditions

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Kidney Cancer

Keywords

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stage III renal cell cancer stage IV renal cell cancer

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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aldesleukin

Intervention Type BIOLOGICAL

Eligibility Criteria

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Exclusion Criteria

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cancer Biotherapy Research Group

OTHER

Sponsor Role lead

Principal Investigators

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Datchen F. Tai, MD

Role: STUDY_CHAIR

Cancer Biotherapy Research Group

Locations

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Cancer Care Center for Southern Indiana

Bloomington, Indiana, United States

Site Status

Bergan Mercy Medical Center

Omaha, Nebraska, United States

Site Status

Baptist Regional Cancer Center - Knoxville

Knoxville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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CBRG-9704

Identifier Type: -

Identifier Source: secondary_id

NBSG-9704

Identifier Type: -

Identifier Source: secondary_id

NCI-V98-1482

Identifier Type: -

Identifier Source: secondary_id

CDR0000066679

Identifier Type: -

Identifier Source: org_study_id