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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-12-31

Study Completion Date

2001-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer

Keywords

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Prostate Cancer Vaccine GVAX Allogeneic cells

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Immunotherapy allogeneic GM-CSF secreting cellular vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Other Identifiers

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G-9705A

Identifier Type: -

Identifier Source: org_study_id