RNA-Loaded Dendritic Cell Cancer Vaccine

Renal Cell Carcinoma Clinical Trial

Official title:

A Phase I/II Study To Examine The Safety, Feasibility, Immunological Response, And Measures Of Clinical Antitumor Activity After Administering Unselected, Autologous, Amplified Tumor Total RNA-Transfected, Dendritic Cell Vaccine (MB-002) To Patients With Metastatic Renal Cell Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00087984
• Other study ID #: MB-002-003
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 16, 2004
• Last updated: February 14, 2013
• Start date: January 2004
• Est. completion date: September 2008

Study information

• Verified date: February 2013
• Source: Argos Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Biological:
• MB-002
Dendritic Cell Immunotherapy

Locations

Country	Name	City	State
Canada	Jewish General Hospital	Montreal	Quebec
Canada	Princess Margaret Hospital	Toronto	Ontario
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	University of California - Irvine	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
Argos Therapeutics

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	No

External Links

•   Kidney Cancer Association