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

AbstractPURPOSE:
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.
AuthorsM A Rosenthal, B Kavar, J S Hill, D J Morgan, R L Nation, S S Stylli, R L Basser, S Uren, H Geldard, M D Green, S B Kahl, A H Kaye
JournalJournal of clinical oncology : official journal of the American Society of Clinical Oncology (J Clin Oncol) Vol. 19 Issue 2 Pg. 519-24 (Jan 15 2001) ISSN: 0732-183X [Print] United States
PMID11208846 (Publication Type: Clinical Trial, Clinical Trial, Phase I, Journal Article)
Chemical References
  • Protoporphyrins
  • Radiation-Sensitizing Agents
  • boron protoporphyrin
Topics
  • Adult
  • Aged
  • Area Under Curve
  • Brain Neoplasms (drug therapy)
  • Drug Administration Schedule
  • Female
  • Glioblastoma (drug therapy)
  • Humans
  • Male
  • Middle Aged
  • Photochemotherapy
  • Protoporphyrins (pharmacokinetics, therapeutic use)
  • Radiation-Sensitizing Agents (pharmacokinetics, therapeutic use)
  • Tissue Distribution

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