RPI.4610 in Treating Patients With Metastatic Kidney Cancer

Phase 2

Completed

• Conditions: Kidney Cancer

• Registration Number: NCT00021021
• Lead Sponsor: Ribozyome

Brief Summary

RATIONALE: RPI.4610 may stop the growth of metastatic kidney cancer by stopping blood flow to the tumor.

PURPOSE: Phase II trial to study the effectiveness of RPI.4610 in treating patients who have metastatic kidney cancer.

Detailed Description

OBJECTIVES: I. Determine the response rate of patients with metastatic renal cell cancer treated with RPI.4610. II. Determine the percentage of these patients with stable disease at 16 weeks after starting treatment with this drug. III. Assess the safety and tolerability of this drug in these patients.

OUTLINE: This is a multicenter study. Patients receive RPI.4610 subcutaneously daily. Treatment continues for 16 weeks in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may continue treatment after 16 weeks. Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Study Timeline

• Study First Submitted: 2001-07-11
• Study Start: 2001-09
• Status Verified: 2002-05
• Study Completion: 2004-02
• Study First Submitted QC: 2004-02-13
• Study First Posted: 2004-02-16
• Last Update Submitted: 2013-03-25
• Last Update Posted: 2013-03-26

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 (1)

Jonsson Comprehensive Cancer Center, UCLA; 🇺🇸 Los Angeles, California, United States