Objective  The poor prognosis of patients with malignant gliomas (MG) has led to the search for new therapeutic strategies. Recently, nimotuzumab has been studied as a new anti-EGFR-receptor humanized monoclonal antibody in patients with MG, who showed improvement of outcome and good tolerability. We conducted phase I of our study to determine the toxicity, tolerated dose, and clinical feasibility of nimotuzumab in combination with concurrent chemoradiotherapy for Chinese MG patients after surgical resection.

  Methods  Patients with pathologically proven grades 3 and 4 glioma were enrolled in the study. The protocol included infusions of nimotuzumab plus standard Stupp schedule (postoperative radiotherapy in a total dose of 60 Gy in combination with daily temozolomide). Patients received 6 weekly infusions of nimotuzumab at three levels (100, 200, and 400 mg/week). If none of the first three patients enrolled at a dose level experienced dose-limiting toxicity (DLT), the dose was increased, as appropriate. If DLT was observed, another three patients were added to the dose level.

  Results  Nine patients with MG were enrolled, including 7 with grade 3 MG and 2 with glioblastoma. The treatment was well tolerated, and no evidence of grade 3 or 4 adverse events was detected, even at the highest level (400 mg/week). Grade 1 or 2 myelosuppression was the most common toxicity. Three months after treatment, stable disease occurred in 5 patients, whereas progression disease was observed in 4 patients.

  Conclusion  Nimotuzumab combined with concurrent chemoradiotherapy was associated with mild toxicity in Chinese MG patients.