NCT00140387

Brief Summary

The objective of this study is to evaluate the safety and efficacy of priming vaccinations, and subsequent boosting vaccinations with Human GM-CSF Gene Transduced Irradiated Prostate Allogeneic Cancer Cell Vaccines (Allogeneic Prostate GVAX®). Clinical observations and laboratory measurements will be monitored to evaluate safety and toxicity. Additionally, the antitumor effects of Allogeneic Prostate GVAX® on serum PSA levels will be evaluated and antitumor responses will be quantitated.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for phase_1 prostate-cancer

Timeline
Completed

Started May 1999

Shorter than P25 for phase_1 prostate-cancer

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

May 1, 1999

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2001

Completed
4.5 years 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

September 1, 2005

Status Verified

August 1, 2005

First QC Date

August 30, 2005

Last Update Submit

August 30, 2005

Conditions

Prostate Cancer

Keywords

ProstateCancerGVAXMetastaticVaccineAllogeneic 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 prostate cancer
  • No evidence of measurable metastatic disease
  • An ECOG performance status of 0 or 1

You may not qualify if:

  • Previous hormonal therapy of any type for prostate cancer
  • Any previous chemotherapy, or prior investigational therapy for prostate cancer
  • Prior Immunotherapy
  • Prior treatment with gene therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 30, 2005

First Posted

September 1, 2005

Study Start

May 1, 1999

Study Completion

March 1, 2001

Last Updated

September 1, 2005

Record last verified: 2005-08