Radioimmunotherapy (RIT) Dose-Escalation Studies in Prostate Cancer Using Anti-PSMA Antibody 177Lu-J591: RIT Alone and RIT in Combination With Docetaxel
Abstract
Phase I dose escalation studies with 177Lu-DOTA-huJ591 using dose fractionation regimen will be performed in patients with PCa and who have recurrent and/or metastatic disease. The 177Lu dose (20-45 mCi/m2) will be escalated in 6 different dose levels (3-6 patients at each dose level). At each dose level the patients would receive two doses of 177Lu-J591 Mab, 2 weeks apart. The dose of huJ591 MAb will remain fixed at a total dose of 20 mg/dose. The phase I protocol was initially approved by lRB at New York Cornell Medical Center in Aug 2004. All the paperwork was submitted to HSSRB at DOD, for their approval of the protocol. Finally after 2.5 years of discussions, the protocol was finally approved in by FDA in January 2007 and DOD by June 2007. We hope to start recruiting patients very soon. Six months ago, we prepared a new lot of DOTA-J591 under GMP conditions for clinical studies. All the qc studies were performed to start the clinical trial.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2006
- Accession Number
- ADA477385
Entities
People
- Shankar Vallabhajosula
Organizations
- Cornell University