Two-Arm Study of a DNA Vaccine Encoding Prostatic Acid Phosphatase (PAP) in Patients With Non-Metastatic Castrate-Resistant Prostate Cancer - Full Text View

Sponsors and Collaborators:	University of Wisconsin, Madison National Cancer Institute (NCI)
Information provided by:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00849121

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

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:	March 2014
Estimated Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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
2: Experimental 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.

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	Recruiting
Madison, Wisconsin, United States, 53792
Contact: Clinical Trials Office (Cancer Connect) 800-622-8922

Sponsors and Collaborators

University of Wisconsin, Madison

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Douglas McNeel, MD

University of Wisconsin, Madison

More Information

No publications provided

Responsible Party:	University of Wisconsin Paul P. Carbone Comprehensive Cancer Center ( Douglas McNeel, MD, PhD )
Study ID Numbers:	2008-0102, CO08802
Study First Received:	February 19, 2009
Last Updated:	April 13, 2009
ClinicalTrials.gov Identifier:	NCT00849121 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:

Vaccine
pTVG-HP
Prostate Cancer
Castrate Resistant

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on August 30, 2009