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

Cell Genesys20 enrolled

Overview

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.

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 * 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

Data from ClinicalTrials.gov

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