Two-Arm Study of a DNA Vaccine Encoding Prostatic Acid Phosphatase (PAP) in Patients With Non-Metastatic Castrate-Resistant Prostate Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
University of Wisconsin, Madison
Collaborator:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00849121
First received: February 19, 2009
Last updated: April 17, 2013
Last verified: April 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The investigators are trying to find new methods to treat prostate cancer. The approach 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.
The vaccine, called pTVG-HP, is a piece of DNA genetic material that contains genetic code for a protein that is made by the prostate gland, called prostatic acid phosphatase (PAP). The vaccine will be given together with a substance called an adjuvant. Adjuvants are typically given with vaccines and can improve the effect of the vaccine. The adjuvant that will be used in this study is called granulocyte-macrophage colony-stimulating factor (GM-CSF).
The main purpose of this study is to find out whether the vaccine generates long-lived immune responses, and whether a better schedule of vaccination can be found by doing frequent laboratory testing for immune responses. The investigators also want to see if the vaccine stimulates any immune reaction against cancer cells.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Biological: pTVG-HP with rhGM-CSF |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Pilot Randomized Two-Arm Study of a DNA Vaccine Encoding Prostatic Acid Phosphatase (PAP) in Patients With Non-Metastatic Castrate-Resistant Prostate Cancer |
Resource links provided by NLM:
Further study details as provided by University of Wisconsin, Madison:
Primary Outcome Measures:
- To determine the safety of serial intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant, in patients with non-metastatic castrate-resistant prostate cancer. [ Time Frame: While receiving vaccine treatment ] [ Designated as safety issue: Yes ]
- To determine if the vaccine generates long-lived immune responses. [ Time Frame: Immune responses will be evaluated during treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To determine if immunization with a DNA vaccine encoding PAP prolongs PSA doubling time in patients with non-metastatic castrate-resistant prostate cancer [ Time Frame: PSA will be obtained about every 4-6 weeks while on treatment ] [ Designated as safety issue: No ]
- To determine the 1-year metastasis-free survival in patients with non-metastatic castrate-resistant prostate cancer treated with a DNA vaccine encoding PAP [ Time Frame: one year from study entry ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 34 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then every 12 weeks until disease progression.
|
Biological: pTVG-HP with rhGM-CSF
pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for 6 total doses, followed by pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. every 3 months until radiographic disease progression
Other Name: DNA-based vaccine encoding PAP
|
|
Experimental: 2
Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then given every 2-week, 4-week, or 3-month intervals as dictated by cellular immune response measurement.
|
Biological: pTVG-HP with rhGM-CSF
pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for a minimum of 6 total doses, and continuing biweekly until evidence of T-cell immune response, and then following a booster schedule as defined by evidence of T-cell immune response.
Other Name: DNA-based vaccine encoding PAP
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of Prostate Cancer
- Castrate Resistant Disease with rising PSA despite continuous treatment with orchiectomy or a LHRH agonist
- Rising PSA after treatment and withdrawal of anti-androgen
- Serum Testosterone <50ng/mL
- Normal organ function per laboratory tests
Exclusion Criteria:
- No evidence of immunosuppression or on treatment with immunosuppressive agents
- Cannot have discontinued LHRH agonist treatment (if not previously treated by orchiectomy) within 6 months prior to study entry
- Must not be concurrently taking other medications or supplements with known hormonal effects (other than the LHRH agonist noted above).
- Cannot have any evidence for metastatic disease on bone or CT scan
- Unable or unwilling to undergo two leukapheresis procedure
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00849121
Locations
| United States, Wisconsin | |
| University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | |
| 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: | University of Wisconsin, Madison |
| ClinicalTrials.gov Identifier: | NCT00849121 History of Changes |
| Other Study ID Numbers: | CO08802, CO08802 |
| Study First Received: | February 19, 2009 |
| Last Updated: | April 17, 2013 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by University of Wisconsin, Madison:
|
Vaccine pTVG-HP Prostate Cancer Castrate Resistant |
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 May 19, 2013