Trial Information

Summary: Phase I Trial of Adenovirus- Mediated IL-12 Gene Transduction in Patients with Radiorecurrent Prostate Cancer

The purpose of this research study is to test an experimental approach using gene therapy for prostate cancer that has come back after radiation therapy. The overall goal of this research study is to see if prostate cancer cells can be changed to make a substance called Interleukin 12(IL-12). IL-12 stimulates white blood cells to fight infections and possibly cancer cells. The first purpose of this study is to determine the highest dose of IL-12 that can be safely tolerated by research study participants. The second purpose of the study is to find out toxicity or side effects of IL-12. Although there is evidence in laboratory animals that IL-12 can stimulate the immune system to shrink tumors and prolong survival, we do not know if this will work in humans. This study is not designed to provide participants a direct clinical benefit.
There will be no charge for experimental aproach using gene therapy or the monitoring associated with this research study. Monitoring will occur in a specially designated clinical research center.
No Compensation Provided

Patient Inclusion/Exclusion Criteria:

1) A local recurrence of prostate cancer (in or next to gland) following treatment by radiation therapy(either external beam or seed implantation);
2) Rising PSA(Prostate Specific Antigen) on at least three occasions separated by two weeks;
3) Ultrasound guided biopsy to diagnose recurrent disease within the prostate;
4) No evidence of prostate cancer that has spread on bone scan or CT scan;
5) No hormone therapy at time of enrollment to the research study;

1) Radical Prostatectomy for treatment of prostate cancer;
2) Detectable spread of prostate cancer on bone or CT scan;
3) Take immunosuppressive medication within two months of the study;
4) Acute infection (any bacterial, viral, fungal infection requiring specific therapy;
5) HIV Disease;
6) Other significant medical or psychiatic conditions which pose high risk for investigational study

If you would like to learn more about participating in this study, please send an e-mail message using the form below.