Docetaxel in Combination With GVAX ® Immunotherapy Versus Docetaxel and Prednisone in Prostate Cancer Patients

This study has been terminated.

( Accrual and treatment with CG1940/CG8711 stopped due to IDMC recommendation. )

First Received: August 19, 2005 Last Updated: September 19, 2008 History of Changes

Sponsor:	Cell Genesys
Information provided by:	Cell Genesys
ClinicalTrials.gov Identifier:	NCT00133224

Purpose

The primary objective of this study is to compare the duration of survival between patients receiving docetaxel in combination with the GVAX® vaccine for prostate cancer versus patients receiving docetaxel and prednisone treatment in patients with prostate cancer who no longer respond to hormone therapy, who have documented metastases with pain. Patients may have had up to one prior non-taxane chemotherapy treatment.

Condition	Intervention	Phase
Prostate Cancer	Biological: Immunotherapy allogeneic GM-CSF secreting cellular vaccine Drug: Chemotherapy (docetaxel and prednisone)	Phase III

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 Docetaxel in Combination With CG1940 and CG8711 Versus Docetaxel and Prednisone in Taxane-Naïve Patients With Metastatic Hormone-Refractory Prostate Cancer With Pain

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

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

U.S. FDA Resources

Further study details as provided by Cell Genesys:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Time to disease progression. Time to pain progression. [ Time Frame: 0 ] [ Designated as safety issue: No ]

Enrollment:	408
Study Start Date:	July 2005
Estimated Study Completion Date:	June 2009
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Biological: Immunotherapy allogeneic GM-CSF secreting cellular vaccine Immunotherapy allogeneic GM-CSF secreting cellular vaccine
2	Drug: Chemotherapy (docetaxel and prednisone) Chemotherapy (docetaxel and prednisone)

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
ECOG performance status ≤2 (Performance status of 3 if due to bone pain)
Any Gleason score
Only one prior treatment with systemic chemotherapy
No prior treatment with gene therapy
No prior immunotherapy for prostate cancer
Taxane naïve
Experiencing cancer-related pain

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00133224

Show 115 Study Locations

Sponsors and Collaborators

Cell Genesys

More Information

No publications provided

Responsible Party:	Cell Genesys, Inc. ( Cell Genesys, Inc. )
Study ID Numbers:	G-0034, VITAL-2
Study First Received:	August 19, 2005
Last Updated:	September 19, 2008
ClinicalTrials.gov Identifier:	NCT00133224 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Cell Genesys:

Advanced Prostate Cancer
HRPC
Prostate
Cancer
Metastatic
Hormone-refractory
GVAX

Chemotherapy
Taxotere
Docetaxel
Prednisone
Vaccine
Allogeneic cells

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Prednisone
Antineoplastic Agents, Hormonal
Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms

Genital Diseases, Male
Glucocorticoids
Hormones
Pharmacologic Actions
Docetaxel
Neoplasms
Neoplasms by Site
Therapeutic Uses
Prostatic Neoplasms

ClinicalTrials.gov processed this record on November 09, 2009