Vaccine Immunotherapy for Prostate Cancer
Abstract
The goal of this Clinical Trial Developmental Award (CTDA) was to develop and complete the required administrative tasks necessary to begin a Phase II clinical trial of an adenovirus/PSA (Ad/PSA) vaccine in men with recurrent prostate cancer and a Phase I clinical trial of the combination of the Ad/PSA vaccine along with immunostimulatory CpG ODN. The tasks included the design and construction of the clinical protocols, informed consent forms, submission to the institutional committees that include the Protocol Review and Monitoring Committee, Human Subjects Committee (IRB), Biosafety Committee, Pharmacy and Therapeutics Committee; the NIH Recombinant DNA Advisory Committee (RAC), and the food and Drug Administration (FDA). In addition, although not funded by the CTDA, we were required by the FDA to perform Pharmacology/Toxicology and Histopathology Studies and to obtain a complete DNA sequence of the Ad/PSA vaccine.
Document Details
- Document Type
- Technical Report
- Publication Date
- Jul 01, 2006
- Accession Number
- ADA462829
Entities
People
- David Lubaroff
Organizations
- University of Iowa