Prime-Boost Dose Scheduling Trial for Human GM-CSF Gene Transduced Irradiated Prostate Allogeneic Cancer Cell Vaccines (Allogeneic Prostate GVAX®)

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

NCT00140387

G-9802

Details and patient eligibility

About

The objective of this study is to evaluate the safety and efficacy of priming vaccinations, and subsequent boosting vaccinations with Human GM-CSF Gene Transduced Irradiated Prostate Allogeneic Cancer Cell Vaccines (Allogeneic Prostate GVAX®). Clinical observations and laboratory measurements will be monitored to evaluate safety and toxicity. Additionally, the antitumor effects of Allogeneic Prostate GVAX® on serum PSA levels will be evaluated and antitumor responses will be quantitated.

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of adenocarcinoma prostate cancer
• No evidence of measurable metastatic disease
• An ECOG performance status of 0 or 1

Exclusion criteria

• Previous hormonal therapy of any type for prostate cancer
• Any previous chemotherapy, or prior investigational therapy for prostate cancer
• Prior Immunotherapy
• Prior treatment with gene therapy

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)