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A Phase I Study of Vaccine Replicon Particles (VRP) Expressing Prostate-Specific Membrane Antigen (PSMA) in Patients with Prostate Cancer
[Protocol 08-028]
- Full Title :
- A PHASE I DOSE ESCALATION TRIAL OF VACCINE REPLICON PARTICLES (VRP) EXPRESSING PROSTATE-SPECIFIC MEMBRANE ANTIGEN (PSMA) IN SUBJECTS WITH PROSTATE CANCER
- Purpose :
The purpose of this research is to find the highest dose of a new cancer vaccine that can be given safely in men with advanced prostate cancer that does not respond to hormonal therapy. This vaccine is a genetically modified immunotherapeutic agent designed to slow the growth of prostate cancer.
The vaccine is comprised of two components: a protein called prostate-specific membrane antigen (PSMA) and an inactivated virus called VRP (vaccine replicon particles). Researchers want to learn what dose of the vaccine is necessary to induce an immune response in patients. This will be determined by blood tests (to determine levels of PSA, antibodies, and white blood cells) and imaging tests.
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have a diagnosis of metastatic prostate cancer that is no longer responding to hormonal therapy.
- At least 4 weeks must have passed since completion of prior radiation therapy or chemotherapy and entry into the study, and patients must have recovered from any side effects.
- Patients may not have previously received gene therapy, immunotherapy, or a PSMA-based vaccine.
- Patients must be age 18 or older.
For more information and to inquire about eligibility for this study, please contact Dr. Susan F. Slovin at 646-422-4470.
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