Radioimmunotherapy (RIT) Dose-Escalation Studies in Prostate Cancer Using Anti-PSMA Antibody 177Lu-J591: RIT Alone and RIT in Combination with Docetaxel
Abstract
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 and/or metastatic disease, 177Lu dose (20-40 mCi/m2) was escalated in 5 different dose levels (3-6 patients at each dose level). At each dose level, the patients received two doses of 177Lu-J591 mab (20 mg/dose), 2 weeks apart. A total of 22 patients have been treated and the MTD with the dose fractionation is regarded as 40 mCi/m2 dose given twice two weeks apart. The results of this study clearly demonstrate that administration of 177Lu-J591 treatment dose in a fractionated dose regimen is relatively safe with reduced hematologic toxicity than a single dose treatment. Building upon this data, a phase I fractionated-dose 177Lu-J591 plus docetaxel, has begun enrollment. This protocol represents the intent of the SOW-4 in the original grant application. Patients will receive docetaxel, 75 mg/m2 every 21 days As of July 2009, two patients were recruited in group 1 (20 mCi/m2). Due to protocol amendments, the revised protocol was resubmitted to HSRRB for review. We plan to complete recruitment in this trial before September 2010.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2009
- Accession Number
- ADA518243
Entities
People
- Shankar Vallabhajosula
Organizations
- Cornell University