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

This study has been completed.

Sponsored by:	Cell Genesys
Information provided by:	Cell Genesys
ClinicalTrials.gov Identifier:	NCT00140387

Purpose

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.

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

MedlinePlus related topics: Cancer Prostate Cancer

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

U.S. FDA Resources

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 Cell Vaccines (Allogeneic Prostate GVAX®) in Hormone-naïve Prostate Cancer Patients

Further study details as provided by Cell Genesys:

Estimated Enrollment:	20
Study Start Date:	May 1999
Estimated Study Completion Date:	March 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
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

Contacts and Locations

No Contacts or Locations Provided

More Information

Study ID Numbers:	G-9802
Study First Received:	August 30, 2005
Last Updated:	August 30, 2005
ClinicalTrials.gov Identifier:	NCT00140387
Health Authority:	United States: Food and Drug Administration

Keywords provided by Cell Genesys:

Prostate
Cancer
GVAX

Metastatic
Vaccine
Allogeneic cells

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 13, 2009