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

This study has been completed.

First Received: August 30, 2005 No Changes Posted

Sponsor:	Cell Genesys
Information provided by:	Cell Genesys
ClinicalTrials.gov Identifier:	NCT00140400

Purpose

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.

Condition	Intervention	Phase
Prostate Cancer	Biological: Immunotherapy allogeneic GM-CSF secreting cellular vaccine	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

Genetics Home Reference related topics: Help Me Understand Genetics

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Granulocyte-macrophage colony-stimulating factor Sargramostim

U.S. FDA Resources

Further study details as provided by Cell Genesys:

Estimated Enrollment:	50
Study Start Date:	May 1999
Estimated Study Completion Date:	January 2001

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Study ID Numbers:	G-9803
Study First Received:	August 30, 2005
Last Updated:	August 30, 2005
ClinicalTrials.gov Identifier:	NCT00140400 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Cell Genesys:

Prostate
Cancer
Advanced prostate cancer
Metastatic

Hormone-refractory
GVAX
Vaccine
Allogeneic cells

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists

Urogenital Neoplasms
Genital Diseases, Male
Hormones
Prostatic Neoplasms
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010