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


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

While receiving vaccine treatment

Safety Issue:

Yes

Principal Investigator

Douglas McNeel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wisconsin, Madison

Authority:

United States: Food and Drug Administration

Study ID:

CO08802

NCT ID:

NCT00849121

Start Date:

March 2009

Completion Date:

September 2014

Related Keywords:

  • Prostate Cancer
  • Vaccine
  • pTVG-HP
  • Prostate Cancer
  • Castrate Resistant
  • Prostatic Neoplasms

Name

Location

University of Wisconsin Paul P. Carbone Comprehensive Cancer CenterMadison, Wisconsin  53792-6164