Prime-Boost Dose Scheduling Trial for Human GM-CSF Gene Transduced Irradiated Prostate Allogeneic Cancer Vaccine (Allogeneic Prostate GVAX®) in Patients With Hormone-Refractory Prostate Cancer

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

NCT00140400

G-9803

Details and patient eligibility

About

The objective of this study is to evaluate the safety and efficacy of a prime-boost dose schedule of Human GM-CSF Gene Transduced Irradiated Prostate Allogeneic Cancer Vaccine (Allogeneic Prostate GVAX®) as measured by standard toxicity evaluation, changes in PSA, and tumor responses. Additional objectives are to measure the time to PSA and/or clinical disease progression as well as local and systemic immune responses to the vaccine.

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of adenocarcinoma prostate cancer
• Prostate cancer deemed to be unresponsive or refractory to hormone therapy
• An ECOG performance status of 0 or 1

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)