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Phase I Study of a DNA-based Vaccine Targeting Prostatic Acid Phosphatase (PAP) in Patients With Stage D0 Prostate Cancer

Phase 1
18 Years
Not Enrolling
Prostate Cancer

Thank you

Trial Information

Phase I Study of a DNA-based Vaccine Targeting Prostatic Acid Phosphatase (PAP) in Patients With Stage D0 Prostate Cancer

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 IFN–£-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.

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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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)

Outcome Time Frame:

During study treatment and for 15 year follow-up

Safety Issue:


Principal Investigator

Douglas McNeel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wisconsin, Madison


United States: Food and Drug Administration

Study ID:

HSC 2004-0365



Start Date:

March 2005

Completion Date:

August 2008

Related Keywords:

  • Prostate Cancer
  • Prostate
  • Cancer
  • Stage D0
  • Non-Metastatic
  • Rising PSA
  • Prostatic Neoplasms



University of Wisconsin Madison,, Wisconsin  53792-5666