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REPORT DATE
01-07-2007
REPORT TYPE
Final Addendum
DATES COVERED
Appendices…………………………………………………………………………… 4Lubaroff; final addendum report, page 1.
Vaccine Immunotherapy for Prostate Cancer David M. Lubaroff, PhD Principal Investigator Grant Number PC050647 Final Addendum ReportINTRODUCTION: 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.BODY: We describe below the accomplishments during the one year extension of the award, using the original Statement of Work tasks. The accomplishments include those previously reported at the end of the original one year award.Sequence the Ad5-PSA vaccine -The clinical grade Ad/PSA vaccine was submitted to Lark Technologies. The sequence report indicated that there were no additions to the normal sequences of the PSA insert nor to the adenovirus backbone.Develop protocols, investigator brochures, and IRB forms for the Phase II trial of the Ad/PSA vaccine alone -This task consumed the great majority of time during the first year of the award. Multiple meetings were held among the Principal Investigator (PI) and members of the Clinical Trial Team to make important decisions about the trial protocols. The discussion point included the patient populations to be targeted in the trials, the...