NCT00140348

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P75+ for phase_1 prostate-cancer

Timeline
Completed

Started Dec 2001

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2001

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2005

Completed
Last Updated

December 24, 2007

Status Verified

December 1, 2007

First QC Date

August 30, 2005

Last Update Submit

December 18, 2007

Conditions

Prostate Cancer

Keywords

ProstateCancerAdvanced Prostate CancerMetastaticHormone-refractoryGVAXVaccineAllogeneic cells

Interventions

Immunotherapy allogeneic GM-CSF secreting cellular vaccineBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Transitional cell, small cell, neuroendocrine, or squamous cell prostate cancer
  • Significant cancer related pain
  • Prior gene therapy, chemotherapy, or immunotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

South Orange County Medical Research Center

Laguna Woods, California, 92637, United States

Location

UCSF

San Francisco, California, 94115, United States

Location

West Coast Clinical Research

Tarzana, California, 91356, United States

Location

South Florida Medical Research

Aventura, Florida, 33180, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Northeast Indiana Research

Fort Wayne, Indiana, 46825, United States

Location

University of Michigan Medical Center

Ann Arbor, Michigan, 48109, United States

Location

Fox Chase cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Urology San Antonio

San Antonio, Texas, 78229, United States

Location

Virginia Mason Med. Crt.

Seattle, Washington, 98101, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Prostatic NeoplasmsNeoplasmsNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 30, 2005

First Posted

September 1, 2005

Study Start

December 1, 2001

Study Completion

April 1, 2005

Last Updated

December 24, 2007

Record last verified: 2007-12

Locations

US(12)