A multicenter Phase I safety study of intratumoral photoactivation of talaporfin sodium in patients with refractory solid tumors.

BACKGROUND: Photodynamic therapy (PDT) currently is approved for the palliative treatment of malignancies of the aerodigestive tract using laser-activated porfimer sodium. A new approach has been developed, based on intratumoral placement of a nonlaser light device that activates talaporfin sodium, that may expand the use of PDT to include a broader range of treatment-resistant malignancies. The safety of this approach was assessed in a Phase I study in patients with locally advanced, refractory tumors. METHODS: Twenty-one patients with radiation-resistant or chemotherapy-resistant or inoperable malignancies were enrolled in four cohorts representing four light doses. Patients were treated with a single intratumoral light device and a fixed photosensitizer dose. Safety assessments were based on review of adverse events (AEs) and serious adverse events (SAEs), and independent evaluation of computed tomography (CT) images. RESULTS: The observed occurrence of treatment-related AEs and SAEs was minimal. No cutaneous phototoxicity was observed in any patient. The overall observed tumor response rate was 33%. CONCLUSIONS: Photoactivation of talaporfin sodium using intratumoral nonlaser light was found to be safe in the patient population of the current study at all light dose levels tested.