Dose Escalation and Efficacy Trial of GVAX® Prostate Cancer Vaccine

A Phase I/II Dose Escalation and Efficacy Trial of GVAX® Prostate Cancer Vaccine in Patients With Metastatic Hormone-Refractory Prostate Cancer

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00140348

Enrollment

Registered

2005-09-01

Start date

2001-12-31

Completion date

2005-04-30

Last updated

2007-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

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

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.

Interventions

BIOLOGICALImmunotherapy allogeneic GM-CSF secreting cellular vaccine

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026