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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

Tracking Information
First Submitted Date  ICMJE December 19, 2007
First Posted Date  ICMJE December 28, 2007
Last Update Posted Date November 19, 2019
Study Start Date  ICMJE March 2005
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 27, 2010)
  • 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 ]
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 19, 2007)
Safety [ Time Frame: During study treatment and for 15 year follow-up ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2007)
Efficacy: Immune Response and PSA response [ Time Frame: During treatment and one year follow-up ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prostatic Acid Phosphatase (PAP) Vaccine in Patients With Prostate Cancer
Official Title  ICMJE Phase I Study of a DNA-based Vaccine Targeting Prostatic Acid Phosphatase (PAP) in Patients With Stage D0 Prostate Cancer
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • 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
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Cohort Level 1
    pTVG-HP (dose 1: 100 μg) with rhGM-CSF (200 μg); administered i.d. biweekly for 6 total doses
    Intervention: Biological: pTVG-HP with rhGM-CSF
  • Experimental: Cohort Level 2
    pTVG-HP (dose 2: 500 μg) with rhGM-CSF (200 μg); administered i.d. biweekly for 6 total doses
    Intervention: Biological: pTVG-HP with rhGM-CSF
  • Experimental: Cohort Level 3
    pTVG-HP (dose 3: 1,500 μg) with rhGM-CSF (200 μg); administered i.d. biweekly for 6 total doses
    Intervention: Biological: pTVG-HP with rhGM-CSF
Publications * Johnson LE, Olson BM, McNeel DG. Pretreatment antigen-specific immunity and regulation - association with subsequent immune response to anti-tumor DNA vaccination. J Immunother Cancer. 2017 Jul 18;5(1):56. doi: 10.1186/s40425-017-0260-3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 19, 2007)
22
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00582140
Other Study ID Numbers  ICMJE 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 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University of Wisconsin, Madison
Original Responsible Party Douglas McNeel MD/Principal Investigator, University of Wisconsin
Current Study Sponsor  ICMJE University of Wisconsin, Madison
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE United States Department of Defense
Investigators  ICMJE
Principal Investigator: Douglas McNeel, MD University of Wisconsin, Madison
PRS Account University of Wisconsin, Madison
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP