Dose Escalation and Efficacy Trial of GVAX® Prostate Cancer Vaccine

Cell Genesys

Status and phase: Completed; Phase 2; Phase 1

Conditions: Prostate Cancer

Treatments: Biological: Immunotherapy allogeneic GM-CSF secreting cellular vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00140348

G-0010

Details and patient eligibility

About

The purpose of this study is to evaluate clinical and laboratory safety in patients receiving 4 different doses of GVAX® Prostate Cancer Vaccine in order to determine a maximum tolerated dose.

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of adenocarcinoma of the prostate
• Metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy
• Detectable metastases
• ECOG performance status of 0 or 1

Exclusion criteria

• Transitional cell, small cell, neuroendocrine, or squamous cell prostate cancer
• Significant cancer related pain
• Prior gene therapy, chemotherapy, or immunotherapy

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)