Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatments ptvg-hp with rhgm-csf
Phase phase 2
Sponsor University of Wisconsin, Madison
Collaborator National Cancer Institute (NCI)
Start date March 2009
End date February 2014
Trial size 17 participants
Trial identifier NCT00849121, CO08802

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then every 12 weeks until disease progression.
ptvg-hp with rhgm-csf DNA-based vaccine encoding PAP
pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for 6 total doses, followed by pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. every 3 months until radiographic disease progression
(Experimental)
Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then given every 2-week, 4-week, or 3-month intervals as dictated by cellular immune response measurement.
ptvg-hp with rhgm-csf DNA-based vaccine encoding PAP
pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for a minimum of 6 total doses, and continuing biweekly until evidence of T-cell immune response, and then following a booster schedule as defined by evidence of T-cell immune response.

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.
time frame: 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
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.
time frame: 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.
time frame: Starting at Treatment Day 0 and continuing every 4-6 weeks until end of treatment period, an average of 2 years
The Number of Participants Who Are Metastasis-free at One Year.
time frame: one year from study entry

Eligibility Criteria

Male participants at least 18 years old.

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

Additional Information

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
Principal investigator Douglas McNeel, MD
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by University of Wisconsin, Madison.