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Dose Escalation and Efficacy Trial of GVAX® Prostate Cancer Vaccine

NCT ID: NCT00140348

Last Updated: 2007-12-24

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

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-12-31

Study Completion Date

2005-04-30

Brief Summary

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The purpose of this study is to evaluate clinical and laboratory safety in patients receiving 4 different doses of GVAX® Prostate Cancer Vaccine in order to determine a maximum tolerated dose.

Detailed Description

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Conditions

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Prostate Cancer

Keywords

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Prostate Cancer Advanced Prostate Cancer Metastatic Hormone-refractory GVAX Vaccine Allogeneic cells

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Immunotherapy allogeneic GM-CSF secreting cellular vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of adenocarcinoma of the prostate
* Metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy
* Detectable metastases
* ECOG performance status of 0 or 1

Exclusion Criteria

* Transitional cell, small cell, neuroendocrine, or squamous cell prostate cancer
* Significant cancer related pain
* Prior gene therapy, chemotherapy, or immunotherapy
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Cell Genesys

INDUSTRY

Sponsor Role lead

Locations

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South Orange County Medical Research Center

Laguna Woods, California, United States

Site Status

UCSF

San Francisco, California, United States

Site Status

West Coast Clinical Research

Tarzana, California, United States

Site Status

South Florida Medical Research

Aventura, Florida, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

Carle Cancer Center

Urbana, Illinois, United States

Site Status

Northeast Indiana Research

Fort Wayne, Indiana, United States

Site Status

University of Michigan Medical Center

Ann Arbor, Michigan, United States

Site Status

Fox Chase cancer Center

Philadelphia, Pennsylvania, United States

Site Status

Urology San Antonio

San Antonio, Texas, United States

Site Status

Virginia Mason Med. Crt.

Seattle, Washington, United States

Site Status

Seattle Cancer Care Alliance

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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G-0010

Identifier Type: -

Identifier Source: org_study_id