Adjuvant Immunotherapy for Patients at High Risk of Recurrence Following Radiation Therapy for Prostate Cancer
Abstract
Pre-clinical testing has shown that subcutaneous injection of an Ad-sig-TAA/ecdCD40L adenoviral vaccine strategy overcomes anergy to tumor associated antigens (TAA) in mice which are genetically engineered to be tolerant of these antigens. Two injections of the vector confer up to a year's immunity and induce regressions of TAA positive tumor even in old (18mo. Old) mice which are known to be poorly responsive to vaccination. This is important since diminished response to vaccine has been seen clinically in human subjects in the age range of peak prevalence of prostate cancer. We have chosen to use hMUC-1, an antigen which is a marker of poor prognosis in prostate cancer, for the clinical development of this vaccine. We have completed the development of a phase I clinical protocol of the ad-sig-hMUC-1/ecdCD40L adenoviral vector vaccine for individuals diagnosed with localized prostate cancer who have evidence of recurrence of their prostate cancer (rising PSA) following radiation therapy for clinically localized disease. We are in the midst of completing the pharmacology, toxicology, and biodistribution assays, GMP production of the Ad-sig-hMUC-1/ecdCD40L and the quality control testing of the GMP production, all of which are needed for FDA approval of the phase I trial is arranged.
Document Details
- Document Type
- Technical Report
- Publication Date
- Aug 01, 2005
- Accession Number
- ADA466640
Entities
People
- Albert B. Deisseroth