Phase I and pharmacokinetic study of photodynamic therapy for high-grade gliomas using a novel boronated porphyrin

Purpose: To determine the recommended dose, toxicity profile, end pharmacok inetics of a novel boronated porphyrin (BOPP) for photodynamic therapy (PDT ) of intracranial tumors. Patients and Methods: BOPP was administered alone in increasing doses (0.25 , 0.5, 1.0, 2.0, 4.0, or 8.0 mg/kg) preoperatively in patients with intracr anial tumors undergoing postresection PDT until dose-limiting toxicity (DLT ) was observed. Results: Twenty-nine assessable patients with intracranial tumors received BOPP intravenously 24 hours before surgery. The recommended dose was 4 mg/k g. Dose escalation was limited by thrombocytopenia. The most common nonhema tologic toxicity was skin photosensitivity. Pharmacokinetic parameters show ed increased area under the plasma concentration-time curve and maximum con centration with increased dose. Tumor BOPP concentrations also increased wi th increased dose. Conclusion: BOPP at a dose of 4 mg/kg was well tolerated. DLT was thrombocy topenia, and photosensitivity was the only other toxicity of note. The effi cacy of PDT using BOPP requires further exploration. J Clin Oncol 19:519-52 4, (C) 2001 by American Society of Clinical Oncology.