RNA-Loaded Dendritic Cell Cancer Vaccine

Phase 1

Completed

• Conditions: Renal Cell Carcinoma
• Interventions: Biological: MB-002

• Registration Number: NCT00087984
• Lead Sponsor: Argos Therapeutics

Brief Summary

The purpose of this trial is to examine the safety, feasibility, immunological response, and clinical antitumor activity of administering a dendritic cell vaccine to patients with metastatic renal cell carcinoma.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2004-07-16
• Study First Submitted QC: 2004-07-19
• Study First Posted: 2004-07-20
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Disposition First Submitted: 2013-01-22
• Status Verified: 2013-02
• Disposition First Submitted QC: 2013-02-14
• Last Update Submitted: 2013-02-14
• Disposition First Posted: 2013-02-18
• Last Update Posted: 2013-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• Have a new diagnosis of metastatic renal cell carcinoma;
• Must be at least 18 years or older;
• Have a scheduled unilateral nephrectomy;
• ECOG of 0 or 1;
• Free of brain metastases by CT or MRI;
• Normal renal function in contralateral kidney;
• Male or non-pregnant/non-lactating female on appropriate birth control methods while on study;
• Clinically acceptable screening results.
• No immunosuppressive therapy not limited to corticosteroids (including topical steroids or steroid containing inhalers), azathioprine cyclosporine two months prior to study entry;
• No active autoimmune disease

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MB-002-003	MB-002	-

Primary Outcome Measures

Name	Time	Method
To examine the safety of multiple administrations of MB-002 in patients with newly diagnosed, metastatic renal cell carcinoma.	From registration until disease progression or withdrawal from study
To measure clinical antitumor activity including objective tumor response and an estimate of time to tumor progression (or progression-free interval).	From registration until disease progression or withdrawal from study

Trial Locations

Locations (5)

University of California - Irvine; 🇺🇸 Orange, California, United States

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

Jewish General Hospital; 🇨🇦 Montreal, Quebec, Canada

Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States