Interleukin-2 in Treating Patients With Metastatic or Recurrent Kidney Cancer

Phase 2

• Conditions: Kidney Cancer

• Registration Number: NCT00002846
• Lead Sponsor: Blumenthal Cancer Center at Carolinas Medical Center

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 low-dose interleukin-2 in treating patients with metastatic or recurrent kidney cancer.

Detailed Description

OBJECTIVES:

* Assess the response rate and survival of patients with metastatic renal cell carcinoma treated with low-dose intravenous interleukin-2.

* Assess the toxicity associated with this treatment.

OUTLINE: Patients receive low-dose intravenous interleukin-2 every 8 hours for a maximum of 15 doses in week 1 and again in week 3. Stable and responding patients receive a second course beginning approximately 2 months after initiation of the first course. Responding patients may continue therapy every 2 months provided toxicity is limited.

Patients whose diseased kidney comprises the bulk of the tumor burden at entry undergo nephrectomy.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 14 patients will be accrued for this study.

Study Timeline

• Study Start: 1995-09
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Status Verified: 2003-12
• Last Update Submitted: 2013-12-18
• Last Update Posted: 2013-12-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Carolinas Medical Center; 🇺🇸 Charlotte, North Carolina, United States