Radioimmunotherapy (RIT) Dose-Escalation Studies in Prostate Cancer Using Anti-PSMA Antibody 177Lu-J591: RIT Alone and RIT in Combination with Docetaxel
Annual rept. 15 Sep 2007-14 Sep 2008
CORNELL UNIV ITHACA NY
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In the fall of 2007, we started the Phase I dose escalation studies with 177Lu-DOTA-huJ591 monoclonal antibodies mAb using dose fractionation regimen. In patients with PCa and who have recurrent andor metastatic disease, 177Lu dose 20-40 mCim2 was escalated in 5 different dose levels 3-6 patients at each dose level. So far we have recruited 17 patients in 5 groups. At each dose level, the patients received two doses of 177Lu-J591 mab, 2 weeks apart. The dose of huJ591 MAb remained fixed at 20 mgdose. We hope to complete this first trial by June 2009 and start the combination therapy protocol almost immediately. The combination therapy protocol was approved by our IRB and was submitted to DOD HSRRB for review and approval. We started recruitment of subjects into the combination therapy protocol. Our goal is to complete the study in by September 2010. The revised SOW is attached.
- Medicine and Medical Research