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

Cell Genesys36 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

Immunotherapy allogeneic GM-CSF secreting cellular vaccineBIOLOGICAL

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Data from ClinicalTrials.gov

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