Vaccination Priming and Vaccine Boosting Trial of Allogeneic Human GM-CSF Gene Transduced Irradiated Prostate Cancer Cell Vaccines (GVAX® Vaccine for 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

NCT00140374

G-9705A

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 GVAX® Vaccine for Prostate Cancer. Clinical observations and laboratory measurements will be monitored to evaluate safety and toxicity. Additionally, the antitumor effects of GVAX® Vaccine for Prostate Cancer 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 that has recurred after surgery by PSA
• No evidence of measurable metastatic disease
• An ECOG performance status of 0 or 1

Exclusion criteria

• Transitional cell, small cell or squamous cell prostate carcinomas
• Any previous radiation therapy, prior anti-androgens or prior investigational therapy
• Previous hormonal therapy of any type for prostate cancer
• Previous biological therapy for cancer

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)