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

Cell Genesys

Status and phase: Terminated; Phase 3

Conditions: Prostate Cancer

Treatments: Drug: Chemotherapy (Taxotere and prednisone); Biological: Immunotherapy with allogeneic prostate vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00089856

(VITAL-1)

G-0029

Details and patient eligibility

About

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.

Enrollment: 626 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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626 participants in 2 patient groups

2

Other group

Description:

Standard of care - chemotherapy

Treatment:

Drug: Chemotherapy (Taxotere and prednisone)

1

Experimental group

Description:

Immunotherapy

Treatment:

Biological: Immunotherapy with allogeneic prostate vaccine