Clinical trial NCT00849121: Two-Arm Study of a DNA Vaccine Encoding Prostatic Acid Phosphatase (PAP) in Patients With Non-Metastatic Castrate-Resistant Prostate Cancer
Official title: A Pilot Randomized Two-Arm Study of a DNA Vaccine Encoding Prostatic Acid Phosphatase (PAP) in Patients With Non-Metastatic Castrate-Resistant Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Vaccine
pTVG-HP
Prostate Cancer
Castrate Resistant
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-02-23
Enrollment: 17
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators are trying to find new methods to treat prostate cancer. The approach 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.

The vaccine, called pTVG-HP, is a piece of DNA genetic material that contains genetic code for a protein that is made by the prostate gland, called prostatic acid phosphatase (PAP). The vaccine will be given together with a substance called an adjuvant. Adjuvants are typically given with vaccines and can improve the effect of the vaccine. The adjuvant that will be used in this study is called granulocyte-macrophage colony-stimulating factor (GM-CSF).

The main purpose of this study is to find out whether the vaccine generates long-lived immune responses, and whether a better schedule of vaccination can be found by doing frequent laboratory testing for immune responses. The investigators also want to see if the vaccine stimulates any immune reaction against cancer cells.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With > = Grade 2 Autoimmune Events or >=Toxicities at Least Possibly Related to pTVG-HP With GM-CSF Study Treatment.
timeFrame: From the time the patient begins treatment until 30 days after the last treatment with pTVG-HP vaccine, up to a maximum of 2 years
measure: Number of Participants Who Experience at Least a 3-fold Higher PAP-specific T-cell Frequency or Proliferation Index at One Year Compared to Baseline.
timeFrame: Baseline and 1 year.
Secondary outcomes:
measure: The Number of Participants Who Experience at Least a Two-fold Increase in the PSA Doubling Time During the Treatment Period.
timeFrame: Starting at Treatment Day 0 and continuing every 4-6 weeks until end of treatment period, an average of 2 years
measure: The Number of Participants Who Are Metastasis-free at One Year.
timeFrame: one year from study entry
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Douglas McNeel, MD
role: PRINCIPAL_INVESTIGATOR
References: