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Sponsors and Collaborators: |
University of Iowa Department of Defense |
Information provided by: | University of Iowa |
ClinicalTrials.gov Identifier: | NCT00583752 |
The purpose of this study is to determine whether vaccination with the Ad/PSA vaccine will induce an anti-PSA immunity that will result in the destruction of the remaining prostate cancer cells.
Condition | Intervention | Phase |
Recurrent Prostate Cancer |
Biological: Adenovirus/PSA Vaccine |
Phase II |
MedlinePlus related topics: | Cancer Prostate Cancer |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | Phase II Study of Adenovirus/PSA Vaccine in Men With Recurrent Prostate Cancer After Local Therapy |
Estimated Enrollment: | 50 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
Arm B: Experimental
On Arm B, subjects will be started on androgen deprivation therapy (ADT) 14 days prior to beginning the vaccinations.
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Biological: Adenovirus/PSA Vaccine
1x10E8pfu in Gelfoam subcutaneously on day 0, 30, 60
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Arm A: Experimental
On Arm A, subjects can begin the three vaccinations immediately.
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Biological: Adenovirus/PSA Vaccine
1x10E8pfu in Gelfoam subcutaneously on day 0, 30, 60
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Subjects will be randomized to Arm A (vaccine only) or Arm B (androgen deprivation therapy plus vaccine). On Arm A, subjects can begin the three vaccinations immediately. On Arm B, subjects will be started on androgen deprivation therapy (ADT) 14 days prior to beginning the vaccinations.
Subjects will be vaccinated three times, each injection administered at 30-day intervals. Based upon our earlier clinical trial, the vaccine is considered safe and should not induce any major side effects. We hope that vaccination with this PSA virus will cause the body to produce immunity to the PSA and that immunity will destroy any cell that produces PSA. Since the only cells left in the body that produce PSA will be the cancer cells, we propose that the vaccination and ensuing anti-PSA immunity will kill the prostate cancer cells. Importantly, this treatment should not cause any major side effects as would treatment with anti-cancer drugs.
Ages Eligible for Study: | 19 Years to 90 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: David M Lubaroff, PhD | 319-335-8423 | david-lubaroff@uiowa.edu |
Contact: Pamela Zehr, RN | 319-353-8914 | pamela-zehr@uiowa.edu |
United States, Iowa | |||||
Holden Comprehensive Cancer Center | Recruiting | ||||
Iowa City, Iowa, United States, 52242 | |||||
Contact: David M Lubaroff, PhD 319-335-8423 david-lubaroff@uiowa.edu | |||||
Contact: Pamela Zehr, RN 319-353-8914 pamela-zehr@uiowa.edu | |||||
Principal Investigator: David M Lubaroff, PhD |
University of Iowa |
Department of Defense |
Principal Investigator: | David M Lubaroff, PhD | University of Iowa |
Responsible Party: | University of Iowa ( David Lubaroff, PhD ) |
Study ID Numbers: | 200605706, PC061667/1 |
First Received: | December 20, 2007 |
Last Updated: | December 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00583752 |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board; United States: Federal Government |
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