Greenbrae, California 94904

  • Prostate Cancer

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.


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


Study is Available At:


Original ID:

G-0029


NCT ID:

NCT00089856


Secondary ID:

(VITAL-1)


Study Acronym:


Brief Title:

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


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


Overall Status:

Terminated


Study Phase:

Phase 3


Genders:

Male


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Cell Genesys


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:

Based on futility analysis showing <30% c


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

626


Enrollment Type:

Actual


Study Dates

Start Date:July 2004
Completion Date:October 2008
Completion Type:Actual
Primary Completion Date:October 2008
Primary Completion Type:Actual
Verification Date:November 2008
Last Changed Date:November 3, 2008
First Received Date:August 16, 2004

Study Outcomes

Outcome Type:Primary Outcome
Measure:Survival
Time Frame:0
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Bone pain and bone related events
Time Frame:0
Safety Issues:False

Study Interventions

Intervention Type:Biological
Name:Immunotherapy with allogeneic prostate vaccine
Description:Immunotherapy with allogeneic prostate vaccine
Arm Name:1
Intervention Type:Drug
Name:Chemotherapy (Taxotere and prednisone)
Description:Chemotherapy (Taxotere and prednisone)
Arm Name:2

Study Arms

Study Arm Type:Other
Arm Name:2
Description:Standard of care - chemotherapy
Study Arm Type:Experimental
Arm Name:1
Description:Immunotherapy

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Cell Genesys

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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