[Phase I study on infusion of PJ-203 (degradable starch microspheres) into hepatic. PJ-203 Clinical Study Group]

Degradable Starch Microspheres (DSM) are spherical starch microspheres prepared from partially hydrolysed potato starch and then cross-linked by epichlorohydrin. PJ-203 is a transient intra-arterial embolic material and suspended in physiological saline at a concentration of 60 mg/ml starch microspheres. In the present multi-center cooperative Phase I clinical study, we examined the embolic effect and safety in patients with primary liver cancer (14 cases) and those with metastatic liver cancer (18 cases). The dose of DSM per patient was 300 mg in one minute. DSM was infused in increments of 300 mg, with a wash-out period of one minute between the increments, until the dose reached 1,200 mg. In addition to these four dose groups, one group consisting of patients with metastatic liver cancer received 900 mg in three minutes without interruption. DSM was infused via a catheter which had been inserted into the hepatic artery by means of the Seldinger method or laparotomy. In either primary liver cancer or metastatic liver cancer patients, a satisfactory embolization could be obtained with 900 mg or more DSM. Also, it was confirmed that the embolic period was one hour before and after. Pain was noted in all the groups. Other frequently observed adverse reaction were nausea.vomiting, anorexia and fever (38-39 degrees C). However, these symptoms improved within several hours or days. There was no dose-related incidence in these symptoms. Reduced blood pressure.weak pulse, pressure.heavy sensation in the right hypochondriac region, discomfort in the abdominal.chest region, or perspiration.cold sweat, were observed in 2 to 3 patients.(ABSTRACT TRUNCATED AT 250 WORDS)