RNA-Loaded Dendritic Cell Cancer Vaccine

NCT ID: NCT00087984

Last Updated: 2013-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2008-09-30

Brief Summary

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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

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Conditions

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Renal Cell Carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MB-002-003

Group Type EXPERIMENTAL

MB-002

Intervention Type BIOLOGICAL

Dendritic Cell Immunotherapy

Interventions

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MB-002

Dendritic Cell Immunotherapy

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Argos Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of California - Irvine

Orange, California, United States

Site Status

Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Princess Margaret Hospital

Toronto, Ontario, Canada

Site Status

Jewish General Hospital

Montreal, Quebec, Canada

Site Status

Countries

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United States Canada

Related Links

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http://www.nkca.org

Kidney Cancer Association

Other Identifiers

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MB-002-003

Identifier Type: -

Identifier Source: org_study_id

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