Prime-Boost Dose Scheduling Trial for Human GM-CSF Gene Transduced Irradiated Prostate Allogeneic Cancer Cell Vaccines (Allogeneic Prostate GVAX®)

Phase I/II Study of a Prime-Boost Schedule of Human GM-CSF Gene Transduced Irradiated Prostate Allogeneic Cancer Cell Vaccines (Allogeneic Prostate GVAX®) in Hormone-naïve Prostate Cancer Patients

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00140387

Enrollment

Registered

2005-09-01

Start date

1999-05-31

Completion date

2001-03-31

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, GVAX, Metastatic, Vaccine, Allogeneic cells

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.

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 * No evidence of measurable metastatic disease * An ECOG performance status of 0 or 1

Exclusion criteria

* 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

Outcome results

None listed

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