Phase 2
N=17
Two-Arm Study of a DNA Vaccine Encoding Prostatic Acid Phosphatase (PAP) in Patients With Non-Metastatic Castrate-Resistant Prostate Cancer
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00849121 ↗Enrolled (actual)
17
Serious AEs
23.5%
Results posted
Sep 2014
Primary outcome: Primary: Number of Participants With > = Grade 2 Autoimmune Events or >=Toxicities at Least Possibly Related to pTVG-HP With GM-CSF Study Treatment. — 1; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- pTVG-HP with rhGM-CSF (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- Feb 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With > = Grade 2 Autoimmune Events or >=Toxicities at Least Possibly Related to pTVG-HP With GM-CSF Study Treatment. |
1; 0 | — |
| PRIMARY 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. |
3; 6 | — |
| SECONDARY The Number of Participants Who Experience at Least a Two-fold Increase in the PSA Doubling Time During the Treatment Period. |
3; 4 | — |
| SECONDARY The Number of Participants Who Are Metastasis-free at One Year. |
6; 6 | — |
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
Data sourced from ClinicalTrials.gov (NCT00849121). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.