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Prostatic Acid Phosphatase (PAP) Vaccine in Patients With Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00582140
Recruitment Status : Completed
First Posted : December 28, 2007
Last Update Posted : November 19, 2019
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
University of Wisconsin, Madison

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Prostate Cancer Biological: pTVG-HP with rhGM-CSF Phase 1

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2005
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Secondary Outcome Measures :
  1. Efficacy: Immune Response and PSA response [ Time Frame: During treatment and one year follow-up ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00582140


Locations
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United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
United States Department of Defense
Investigators
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Principal Investigator: Douglas McNeel, MD University of Wisconsin, Madison
More Information
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Additional Information:

Publications of Results:

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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00582140    
Other Study ID Numbers: 2004-0365
CO04806 ( Other Identifier: University of Wisconsin Carbone Cancer Center )
DOD-A-13390 ( Other Identifier: DOD )
A534260 ( Other Identifier: UW Madison )
SMPH/MEDICINE ( Other Identifier: UW Madison )
2004-0365 ( Other Identifier: Institutional Review Board )
First Posted: December 28, 2007    Key Record Dates
Last Update Posted: November 19, 2019
Last Verified: July 2015
Keywords provided by University of Wisconsin, Madison:
Prostate
Cancer
Stage D0
Non-Metastatic
Rising PSA
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases