Inside Clinical Trials: Testing

Inside Clinical Trials Testing Medical Products in People... 

Doxil , of which I had the pleasure of being one of the inventors (1-12), serves as an example of successful passive targeting to tumors in animals and humans (1,3,4,13). The ammonium sulfate (AS) transmembrane inside high/outside low gradient-driven loading is also the basis for doxorubicin (DOX) loading for Targeted Doxil (14), which soon will be tested in clinical trials. 

This prospective phase II trial included 29 consecutive patients with 34 unresectable intrahepatic HCC manifestations. The study population comprised 20 men and 9 women the medium age was 66 years (43-79 years) 23 patients had liver cirrhosis grade Child A, and six Child B. Pre-interventional ascites was present in 7 patients (24%). The mean tumor diameter was 4.5 cm (1.5-10.5 cm). The median minimal dose inside the tumor volume was 20 Gy (12-25 Gy) applied as a single fraction. We used 1-13 brachyther-apy applicators per tumor. During follow-up, MRI was performed 3 days, 6 weeks and every 3 months post treatment, supplemented by clinical examinations and serological liver function tests. Primary endpoints were local tumor control after 12 months as well as safety. Secondary endpoints were progression-free survival and overall survival. 

---