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

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-05-31

Study Completion Date

2001-03-31

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 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.

Detailed Description

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Conditions

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Prostate Cancer

Keywords

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Prostate Cancer GVAX Metastatic Vaccine 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
* 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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Other Identifiers

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G-9802

Identifier Type: -

Identifier Source: org_study_id