Phase II Study of Adenovirus/PSA Vaccine in Men With Hormone - Refractory Prostate Cancer (APP22)
|Hormone Refractory Prostate Cancer||Biological: ADENOVIRUS/PSA VACCINE||Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Adenovirus/PSA Vaccine in Men With Hormone - Refractory Prostate Cancer|
- PSA doubling-time response [ Time Frame: 18 months ]
- Serum PSA levels and Immune response [ Time Frame: 18 months ]
|Study Start Date:||December 2007|
|Estimated Study Completion Date:||July 2017|
|Estimated Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
|Experimental: Arm A||
Biological: ADENOVIRUS/PSA VACCINE
1x10E8 pfu in Gelfoam subcutaneously on days 0, 30, 60
Subjects in this trial will be eligible if they have recent evidence of hormone refractory disease (D3) and either (a) have a positive bone scan or a positive CT scan (with obvious soft tissue metastasis or lymph nodes >1 cm), with a PSA doubling time of >/= 12 months, a total PSA of < 5 mg/ml, and are asymptomatic; or (b) have a negative bone scan with any PSA doubling time, are asymptomatic, and are not a candidate for chemotherapy.
This is a virus vaccine in which the gene for prostate specific antigen (PSA) has been placed into a common cold virus termed adenovirus (Ad) to produce this Ad/PSA product. 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.
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. The investigators 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, the investigators 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00583024
|United States, Iowa|
|Holden Comprehensive Cancer Center|
|Iowa City, Iowa, United States, 52242|
|Principal Investigator:||David M Lubaroff, PhD||University of Iowa|