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Phase I and Pharmacokinetic Study of Photodynamic Therapy for High-Grade Gliomas Using a Novel Boronated Porphyrin

From the Centre for Developmental Cancer Therapeutics; Victorian College of Pharmacy Monash University, Parkville; Institute of Drug Technology, Melbourne, Victoria; Department of Medical Oncology and Clinical Hematology, Royal Melbourne Hospital; Department of Surgery, University of Melbourne, Melbourne; Centre for Pharmaceutical Research, University of South Australia, Adelaide, Australia; and Department of Pharmaceutical Chemistry, School of Pharmacy, University of California, San Francisco, CA.

Address reprint requests to Mark A. Rosenthal, MD, PhD, Department of Medical Oncology and Clinical Oncology, c/o Post Office. Royal Melbourne Hospital, Parkville, Victoria 3050, Australia; email mark.rosenthal{at}ludwig.edu.au

PURPOSE: To determine the recommended dose, toxicity profile, and pharmacokinetics 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 intracranial 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/kg. Dose escalation was limited by thrombocytopenia. The most common nonhematologic toxicity was skin photosensitivity. Pharmacokinetic parameters showed increased area under the plasma concentration-time curve and maximum concentration with increased dose. Tumor BOPP concentrations also increased with increased dose.

CONCLUSION: BOPP at a dose of 4 mg/kg was well tolerated. DLT was thrombocytopenia, and photosensitivity was the only other toxicity of note. The efficacy of PDT using BOPP requires further exploration.

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