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

Cell Genesys

Status and phase: Terminated; Phase 3

Conditions: Prostate Cancer

Treatments: Drug: Chemotherapy (docetaxel and prednisone); Biological: Immunotherapy allogeneic GM-CSF secreting cellular vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00133224

G-0034

VITAL-2

Details and patient eligibility

About

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.

Enrollment: 408 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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408 participants in 2 patient groups

1

Experimental group

Treatment:

Biological: Immunotherapy allogeneic GM-CSF secreting cellular vaccine

2

Other group

Treatment:

Drug: Chemotherapy (docetaxel and prednisone)