- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00140400
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
August 30, 2005 updated by: Cell Genesys
Phase I/II Study of a Prime-Boost Schedule of Human GM-CSF Gene Transduced Irradiated Prostate Allogeneic Cancer Vaccine (Allogeneic Prostate GVAX®) in Hormone-Refractory Prostate Cancer
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
50
Phase
- Phase 2
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 1999
Study Completion
January 1, 2001
Study Registration Dates
First Submitted
August 30, 2005
First Submitted That Met QC Criteria
August 30, 2005
First Posted (Estimate)
September 1, 2005
Study Record Updates
Last Update Posted (Estimate)
September 1, 2005
Last Update Submitted That Met QC Criteria
August 30, 2005
Last Verified
August 1, 2005
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- G-9803
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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