Vaccination Priming and Vaccine Boosting Trial of Allogeneic Human GM-CSF Gene Transduced Irradiated Prostate Cancer Cell Vaccines (GVAX® Vaccine for Prostate Cancer)

Phase I/II Study of Vaccination Priming and Vaccine Boosting With Allogeneic Human GM-CSF Gene Transduced Irradiated Prostate Cancer Cell Vaccines in Patients With Prostate Cancer

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00140374

Enrollment

Registered

2005-09-01

Start date

1998-12-31

Completion date

2001-02-28

Last updated

2005-09-01

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, Vaccine, GVAX, Allogeneic cells

Brief summary

The objective of this study is to evaluate the safety and efficacy of priming vaccinations, and subsequent boosting vaccinations with GVAX® Vaccine for Prostate Cancer. Clinical observations and laboratory measurements will be monitored to evaluate safety and toxicity. Additionally, the antitumor effects of GVAX® Vaccine for Prostate Cancer on serum PSA levels, will be evaluated and antitumor responses will be quantitated.

Interventions

BIOLOGICALImmunotherapy allogeneic GM-CSF secreting cellular vaccine

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Diagnosis of adenocarcinoma prostate cancer that has recurred after surgery by PSA * No evidence of measurable metastatic disease * An ECOG performance status of 0 or 1

Exclusion criteria

* Transitional cell, small cell or squamous cell prostate carcinomas * Any previous radiation therapy, prior anti-androgens or prior investigational therapy * Previous hormonal therapy of any type for prostate cancer * Previous biological therapy for cancer

Outcome results

None listed

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