[Clinical tolerance trial on recombinant human endostatin adenovirus].

Recently, some phase I trials on endostatin has shown broad antitumor activity with low toxicity. This study was to determine the maximal tolerant dose (MTD) of recombinant human endostatin adenovirus Ad-Es for human.For the sake of safety, 1 patient was treated with 1x10(10) VP Ad-Es single intratumoral injection in advance. A total of 14 patients with malignant tumors received weekly intratumoral injection of Ad-Es in a dose-escalation manner (1x10(11) VP, 5x10(11) VP, 1x10(12) VP) for 2 weeks.Toxicity profiles in all 15 cases were available. All patients tolerated well. No dose-limited toxicity (DLT) and serious adverse event were observed during treatment. Main adverse events were injection reaction (40.0%) and fever (53.3%). One patient with nasopharyngeal carcinoma had a minor response, 12 patients showed stable disease and 2 patients had progressive disease.Ad-Es is well tolerated up to 1x10(12) VP. The recommended dose for phase II trial is 1x10(12) VP intratumor injection for 4 consecutive weeks.