GVAX® Vaccine for Prostate Cancer vs Docetaxel & Prednisone in Patients With Metastatic Hormone-Refractory Prostate Cancer - Full Text View

Purpose

The purpose of this study is to compare the duration of survival between GVAX® immunotherapy for prostate cancer and chemotherapy treatment in patients with prostate cancer who no longer respond to hormone therapy, who have documented metastases, and who have not been treated with chemotherapy in the past.

As this is a survival trial and it is difficult to predict when deaths or the primary/secondary endpoints will occur, the anticipated completion dates provided represent the actual completion of accrual, and the timeframes for the primary/secondary endpoints cannot be accurately estimated.

Condition	Intervention	Phase
Prostate Cancer	Biological: Immunotherapy with allogeneic prostate vaccine Drug: Chemotherapy (Taxotere and prednisone)	Phase III

MedlinePlus related topics:

Cancer Prostate Cancer

ChemIDplus related topics:

Docetaxel Prednisone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Phase III Randomized, Open-Label Study of CG1940 and CG8711 Versus Docetaxel and Prednisone in Patients With Metastatic Hormone-Refractory Prostate Cancer Who Are Chemotherapy-Naïve

Further study details as provided by Cell Genesys:

Primary Outcome Measures:

Survival [ Time Frame: 0 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Bone pain and bone related events [ Time Frame: 0 ] [ Designated as safety issue: No ]

Estimated Enrollment:	600
Study Start Date:	July 2004
Estimated Study Completion Date:	September 2007
Estimated Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2 Standard of care - chemotherapy	Drug: Chemotherapy (Taxotere and prednisone) Chemotherapy (Taxotere and prednisone)
1: Experimental Immunotherapy	Biological: Immunotherapy with allogeneic prostate vaccine Immunotherapy with allogeneic prostate vaccine

Eligibility

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

Criteria

Inclusion Criteria:

Confirmed diagnosis of or clinical history consistent with adenocarcinoma of the prostate
Metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy
Detectable metastases
Any Gleason score
ECOG performance status 0-2

Exclusion Criteria:

Prior treatment with chemotherapy
Prior Immunotherapy
Prior treatment with gene therapy
Significant cancer related pain

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00089856

Show 127 Study Locations

Sponsors and Collaborators

Cell Genesys

More Information

Responsible Party:	Cell Genesys, Inc. ( Cell Genesys, Inc )
Study ID Numbers:	G-0029, (VITAL-1)
First Received:	August 16, 2004
Last Updated:	December 19, 2007
ClinicalTrials.gov Identifier:	NCT00089856
Health Authority:	United States: Food and Drug Administration

Keywords provided by Cell Genesys:

Prostate

Cancer

Metastatic

Hormone-refractory

GVAX

Chemotherapy

Taxotere

Docetaxel

Prednisone

Vaccine

Allogeneic cells

Advanced Prostate Cancer

Study placed in the following topic categories:

Docetaxel

Prednisone

Prostatic Diseases

Genital Neoplasms, Male

Urogenital Neoplasms

Prostatic Neoplasms

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Neoplasms

Neoplasms by Site

Antineoplastic Agents, Hormonal

Antineoplastic Agents

Therapeutic Uses

Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists

Genital Diseases, Male

Hormones

Glucocorticoids

Pharmacologic Actions

ClinicalTrials.gov processed this record on July 03, 2008

Sponsored by:	Cell Genesys
Information provided by:	Cell Genesys
ClinicalTrials.gov Identifier:	NCT00089856