Prime-Boost Dose Scheduling Trial for Human GM-CSF Gene Transduced Irradiated Prostate Allogeneic Cancer Vaccine (Allogeneic Prostate GVAX®) in Patients With Hormone-Refractory Prostate Cancer

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00140400

Enrollment

Registered

2005-09-01

Start date

1999-05-31

Completion date

2001-01-31

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, Advanced prostate cancer, Metastatic, Hormone-refractory, GVAX, Vaccine, Allogeneic cells

Brief summary

The objective of this study is to evaluate the safety and efficacy of a prime-boost dose schedule of Human GM-CSF Gene Transduced Irradiated Prostate Allogeneic Cancer Vaccine (Allogeneic Prostate GVAX®) as measured by standard toxicity evaluation, changes in PSA, and tumor responses. Additional objectives are to measure the time to PSA and/or clinical disease progression as well as local and systemic immune responses to the vaccine.

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 * Prostate cancer deemed to be unresponsive or refractory to hormone therapy * An ECOG performance status of 0 or 1

Exclusion criteria

* Transitional cell, small cell, neuroendocrine, or squamous cell prostate cancer * Previous chemotherapy, biological or immunotherapy for cancer * Previous gene therapy for cancer * Significant cancer related pain

Outcome results

None listed

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