title: A multicenter Phase I safety study of intratumoral photoactivation of talaporfin sodium in patients with refractory solid tumors.
abstract: 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.
authors.affiliation: Department of Radiation Oncology, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, USA.
authors.forename: Robert A
authors.initials: RA
authors.lastname: Lustig
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: Vogl
authors.forename: David
authors.initials: D
authors.lastname: Fromm
authors.forename: Rosa
authors.initials: R
authors.lastname: Cuenca
authors.forename: R
authors.initials: R
authors.lastname: Alex Hsi
authors.forename: Anil K
authors.initials: AK
authors.lastname: D'Cruz
authors.forename: Zdenko
authors.initials: Z
authors.lastname: Krajina
authors.forename: Marko
authors.initials: M
authors.lastname: Turić
authors.forename: Anil
authors.initials: A
authors.lastname: Singhal
authors.forename: James C
authors.initials: JC
authors.lastname: Chen
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy*; D010778:Photochemotherapy / Q000009:adverse effects*; D017319:Photosensitizing Agents / Q000008:administration & dosage*; D011166:Porphyrins / Q000008:administration & dosage*
chemical_list: D017319:Photosensitizing Agents; D011166:Porphyrins