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

• ClinicalTrials.gov Identifier: NCT00582140
• Recruitment Status: Completed
• First Posted: December 28, 2007
• Last Update Posted: November 19, 2019
• Sponsor: University of Wisconsin, Madison
• Collaborator: United States Department of Defense
• Information provided by (Responsible Party): University of Wisconsin, Madison

Tracking Information

• First Submitted Date: December 19, 2007
• First Posted Date: December 28, 2007
• Last Update Posted Date: November 19, 2019
• Study Start Date: March 2005
• Actual Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: December 19, 2007): Safety [ Time Frame: During study treatment and for 15 year follow-up ]
• Current Secondary Outcome Measures (submitted: December 19, 2007): Efficacy: Immune Response and PSA response [ Time Frame: During treatment and one year follow-up ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Prostatic Acid Phosphatase (PAP) Vaccine in Patients With Prostate Cancer
• Official Title: 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Prostate Cancer

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 19, 2007): 22
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: August 2008
• Actual Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: 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 )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: University of Wisconsin, Madison
• Original Responsible Party: Douglas McNeel MD/Principal Investigator, University of Wisconsin
• Current Study Sponsor: University of Wisconsin, Madison
• Original Study Sponsor: Same as current
• Collaborators: United States Department of Defense

Investigators

• Principal Investigator: Douglas McNeel, MD; University of Wisconsin, Madison

• PRS Account: University of Wisconsin, Madison
• Verification Date: July 2015