Combined VM26 (teniposide) with radiotherapy for postoperative brain neurospongioma: phase I clinical study

Objective To determine the toxicity, maximal dose and clinical practicality of VM26 (teniposide) plus radiotherapy for postoperative brain neurospongioma. Methods Twenty patients were alloted in phase Ⅰ trial. The total dose was 60 Gy for the field radiotherapy (30 fractions of 2 Gy over six weeks). Teniposide at three dose levels (50 mg/m2, 75 mg/m2 and 100 mg/m2) was given intravenously once a week, totally five weeks. Dose escalation was based on each level, with a minimum of five patients in cohort if severe toxicity was not observed until the maximum tolerance dose(MTD). Results The predominant form of toxicity was hematologic toxicity. Four patients developed grade 3, 4 leucopenia when a second level of MTD (75 mg/m2) was given. Conclusion Combined radiotherapy and teniposide for postoperative brain neurospongioma is well tolerated. The dose of 50 mg/m2 for phase Ⅱ clinical trial was recommended. Key words: Brain neoplasms;  Glioma;  Chemotherapy;  adjuvant;  Radiotherapy;  computer-assisted;  Therapies;  investigational