CompletedNCT00087984Updated Feb 18, 2013

RNA-Loaded Dendritic Cell Cancer Vaccine

A Phase 1/2 interventional study of MB-002 in Renal Cell Carcinoma, sponsored by Argos Therapeutics. Completed at 5 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-02-18.

Sponsored by Argos Therapeutics · Phase 1/2, Interventional, and Treatment

Phase: Phase 1/2
Study type: Interventional
Enrollment: 26
Allocation: Non-randomized
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

Renal Cell Carcinoma

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Keywords

Kidney cancer
Renal cancer

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 26 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.

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Lead sponsor

Argos Therapeutics is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

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

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Single group
Masking: None (open label)
Enrollment: 26 participants (actual)

Study arms

Experimental
MB-002-003
Biological: MB-002

Interventions

BiologicalMB-002
Dendritic Cell Immunotherapy

What researchers measure

Primary outcomes

To examine the safety of multiple administrations of MB-002 in patients with newly diagnosed, metastatic renal cell carcinoma.
Time frame: 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).
Time frame: From registration until disease progression or withdrawal from study

Study locations

5 sites

University of California - Irvine
Orange, California 92868, United States
Roswell Park Cancer Institute
Buffalo, New York 14263, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599, United States
Princess Margaret Hospital
Toronto, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada

References and documents

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 18, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00087984
Lead sponsor: Argos Therapeutics
Responsible party: Sponsor
First posted: Jul 20, 2004
Start date: Jan 2004
Primary completion: Sep 2008
Completion: Sep 2008
Last update: Feb 18, 2013

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

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