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

Argos Therapeutics5 sites in 2 countries26 target enrollmentJanuary 2004

ConditionsRenal Cell Carcinoma

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Renal Cell Carcinoma
Sponsor: Argos Therapeutics
Enrollment: 26
Locations: 5
Primary Endpoint: To examine the safety of multiple administrations of MB-002 in patients with newly diagnosed, metastatic renal cell carcinoma.
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2004

End Date

September 2008

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Argos Therapeutics

Responsible Party

Sponsor

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

Exclusion Criteria

Not provided

Outcomes

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