Prostatic Acid Phosphatase (PAP) Vaccine in Patients With Prostate Cancer
This study has been completed.
Sponsor:
University of Wisconsin, Madison
Collaborator:
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00582140
First received: December 19, 2007
Last updated: March 24, 2011
Last verified: March 2011
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Purpose
The investigators are trying to find new methods to treat prostate cancer. The approach they investigators are taking is to try to enhance patients own immune response against the cancer. In this study the investigators will be testing the safety of a vaccine that may be able to help the body fight prostate cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Biological: pTVG-HP with rhGM-CSF |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Study of a DNA-based Vaccine Targeting Prostatic Acid Phosphatase (PAP) in Patients With Stage D0 Prostate Cancer |
Resource links provided by NLM:
Further study details as provided by University of Wisconsin, Madison:
Primary Outcome Measures:
- The primary objective of this phase I study is to determine if the vaccination with serial intradermal vaccinations of a DNA-based vaccine targeting PAP, with GM-CSF is safe (the investigators will be evaluating the degree of toxicity seen) [ Time Frame: During study treatment and for 15 year follow-up ] [ Designated as safety issue: Yes ]
- To determine whether PAP-specific IFNγ-secreting CD8+ T cells can be generated in patients with stage D0 prostate cancer by means of immunization with a plasmid DNA vaccine encoding PAP. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Efficacy: Immune Response and PSA response [ Time Frame: During treatment and one year follow-up ] [ Designated as safety issue: No ]
| Enrollment: | 22 |
| Study Start Date: | March 2005 |
| Study Completion Date: | August 2008 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Cohort Level 1
pTVG-HP (dose 1: 100 μg) with rhGM-CSF (200 μg); administered i.d. biweekly for 6 total doses
|
Biological: pTVG-HP with rhGM-CSF
pTVG-HP (dose 1: 100 μg) with rhGM-CSF (200 μg); administered i.d. biweekly for 6 total doses
|
|
Experimental: Cohort Level 2
pTVG-HP (dose 2: 500 μg) with rhGM-CSF (200 μg); administered i.d. biweekly for 6 total doses
|
Biological: pTVG-HP with rhGM-CSF
pTVG-HP (dose 2: 500 μg) with rhGM-CSF (200 μg); administered i.d. biweekly for 6 total doses
|
|
Experimental: Cohort Level 3
pTVG-HP (dose 3: 1,500 μg) with rhGM-CSF (200 μg); administered i.d. biweekly for 6 total doses
|
Biological: pTVG-HP with rhGM-CSF
pTVG-HP (dose 3: 1,500 μg) with rhGM-CSF (200 μg); administered i.d. biweekly for 6 total doses
|
Detailed Description:
The purpose of this research is to determine the safety of serial intradermal vaccinations of a DNA vaccine encoding human PAP, with GM-CSF as a vaccine adjuvant, in subjects with stage D0 prostate cancer. In addition, to determine whether PAP-specific IFNУ-secreting CD8+ T cells can be augmented in subjects with stage D0 prostate cancer by means of immunization with a plasmid DNA vaccine encoding PAP.
This is a phase I design where patients will receive the vaccine pTVG-HP with rhGM-CSF administered i.d. biweekly for 6 total doses. There will be three escalating dose cohorts. The dosing cohort considered to be the maximum tolerated dose level will be expanded up to a total of 16 patients.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Must have histologic diagnosis of adenocarcinoma of the prostate
- Must have completed local therapy by surgery and/or ablative radiation therapy at least 2 months prior to entry.
- Must have clinical stage D0 disease defined by the following: In patients treated by surgery, serum PSA values must be > 2 ng/ml by two measurements at least two weeks apart. In patients treated with ablative radiation therapy, three consecutive increases in serum PSA must be documented, with at least a one month interval between values with the finalPSA > 2ng/ml.
- Prior history of a second malignancy is allowed if treated with curative intent disease free for > 5 years.
- Karnofsky performance score of > 70
Exclusion Criteria:
- No evidence of immunosuppression or have been treated with immunosuppressive therapy, such as chemotherapy, chronic treatment dose corticosteroids (greater than the equivalent of 10 mg prednisone per day), or radiation therapy to >30% of the bone marrow, within 6 months of the first vaccination.
- Must not be on concurrent androgen ablative (hormonal) therapy, or must have completed this therapy at least one month prior to study entry.
- Must not have demonstrated PSA progression during any prior hormonal therapy or chemotherapy.
- Must not have known evidence of bone metastases or non-regional lymph node involvement (stage D2 disease) as determined by bone scan or CT scan. -Must not have been treated previously with another investigational anti- tumor vaccine.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00582140
Locations
| United States, Wisconsin | |
| University of Wisconsin | |
| Madison, Wisconsin, United States, 53792 | |
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
| Principal Investigator: | Douglas McNeel, MD | University of Wisconsin, Madison |
More Information
No publications provided
| Responsible Party: | Douglas McNeel MD/Principal Investigator, University of Wisconsin |
| ClinicalTrials.gov Identifier: | NCT00582140 History of Changes |
| Other Study ID Numbers: | HSC 2004-0365, CO04806, DOD-A-13390 |
| Study First Received: | December 19, 2007 |
| Last Updated: | March 24, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Wisconsin, Madison:
|
Prostate Cancer Stage D0 Non-Metastatic Rising PSA |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on June 18, 2013