RNA-Loaded Dendritic Cell Cancer Vaccine

Sponsor

Argos Therapeutics (Industry)

Overall Status

Completed

CT.gov ID

NCT00087984

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

5.2

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Cell Carcinoma	Biological: MB-002	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

26 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Jan 1, 2004

Actual Primary Completion Date :

Sep 1, 2008

Actual Study Completion Date :

Sep 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MB-002-003	Biological: MB-002 Dendritic Cell Immunotherapy

Arm

Intervention/Treatment

Experimental: MB-002-003

Biological: MB-002

Dendritic Cell Immunotherapy

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California - Irvine	Orange	California	United States	92868
2	Roswell Park Cancer Institute	Buffalo	New York	United States	14263
3	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	United States	27599
4	Princess Margaret Hospital	Toronto	Ontario	Canada
5	Jewish General Hospital	Montreal	Quebec	Canada