Prime-Boost Dose Scheduling Trial for Human GM-CSF Gene Transduced Irradiated Prostate Allogeneic Cancer Vaccine (Allogeneic Prostate GVAX®) in Patients With Hormone-Refractory 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

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-05-31

Study Completion Date

2001-01-31

Brief Summary

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The objective of this study is to evaluate the safety and efficacy of a prime-boost dose schedule of Human GM-CSF Gene Transduced Irradiated Prostate Allogeneic Cancer Vaccine (Allogeneic Prostate GVAX®) as measured by standard toxicity evaluation, changes in PSA, and tumor responses. Additional objectives are to measure the time to PSA and/or clinical disease progression as well as local and systemic immune responses to the vaccine.

Detailed Description

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Conditions

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Prostate Cancer

Keywords

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Prostate Cancer Advanced prostate cancer Metastatic Hormone-refractory GVAX 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
* Prostate cancer deemed to be unresponsive or refractory to hormone therapy
* An ECOG performance status of 0 or 1

Exclusion Criteria

* Transitional cell, small cell, neuroendocrine, or squamous cell prostate cancer
* Previous chemotherapy, biological or immunotherapy for cancer
* Previous gene therapy for cancer
* Significant cancer related pain

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Other Identifiers

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G-9803

Identifier Type: -

Identifier Source: org_study_id