The Clinical Development of Thalidomide as an Angiogenesis Inhibitor Therapy for Prostate Cancer
Abstract
The purpose of this award id to evaluate the: 1) Safety and toxicity of neo-adjuvant thalidomide therapy prior to radical prostatectomy in patients with locally advanced prostate carcinoma (PCa); 2) Efficacy of neo-adjuvant thalidomide treatment, as measured by the rate of tumor reduction/ PSA decline; 3) Qualitative measurements of the in vivo effect of thalidomide therapy on the Endothelial and Epithelial compartment. Significance: The ability to assess in vivo the effects of thalidomide as well as identify surrogate markers of anti-angiogenic activity is in valuable to the design of new effective therapies. Prior to the DOD's final decision (April 2002) to sponsor the correlative studies proposed in the grant 18 patients had been entered in this study. Their clinical information is attached. Pending some additional HSRRB required amendments, the patients' research tissue was stored but the funds awarded were not used to perform any of the studies until we obtained the final DOD approval. After April 2002 (when DOD was cited as a partial sponsor) and until we solved all the remaining issues and obtained DOD clearance to proceed (9/2003) we held accrual in this trial. We have re-activated the study and are confident that we will complete patient accrual within 1 year. We are requesting a no-cost extension of 1 year to allow completion of the planned studies.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2003
- Accession Number
- ADA420780
Entities
People
- Danai D. Daliani
Organizations
- The University of Texas MD Anderson Cancer Center