Interleukin-2 Combined With Monoclonal Antibody Therapy in Treating Patients With Kidney, Bladder, or Lung Cancer That Has Not Responded to Previous Treatment

Phase 1

Completed

• Conditions: Lung Cancer; Bladder Cancer; Kidney Cancer

• Registration Number: NCT00016237
• Lead Sponsor: EMD Serono

Brief Summary

RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Interleukin-2 combined with a monoclonal antibody may be an effective treatment for kidney, bladder, or lung cancer.

PURPOSE: Phase I trial to study the effectiveness of interleukin-2 combined with a monoclonal antibody in treating patients who have kidney, bladder, or lung cancer that has not responded to previous treatment.

Detailed Description

OBJECTIVES: I. Determine the maximum tolerated dose of KSA-interleukin-2 in patients with refractory epithelial carcinoma. II. Characterize the pharmacokinetics of this drug in these patients. III. Assess the overall toxicity and safety of this drug in these patients. IV. Determine the rate of objective response in patients treated with this drug.

OUTLINE: This is a dose-escalation, multicenter study. Patients receive KSA-interleukin-2 (KSA-IL-2) IV over 1 hour on days 1-5. Treatment repeats every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of KSA-IL-2 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which more than 33% of the patients experience a dose-limiting toxicity. Patients are followed at 30 days.

PROJECTED ACCRUAL: Approximately 12-24 patients will be accrued for this study within 6-12 months.

Study Timeline

• Study Start: 2000-12
• Study First Submitted: 2001-05-06
• Status Verified: 2002-06
• Study First Submitted QC: 2004-01-06
• Study First Posted: 2004-01-07
• Last Update Submitted: 2013-10-22
• Last Update Posted: 2013-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (2)

Lombardi Cancer Center; 🇺🇸 Washington, District of Columbia, United States

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States