PMID- 14534895
OWN - NLM
STAT- MEDLINE
DCOM- 20031030
LR  - 20041117
IS  - 0008-543X (Print)
IS  - 0008-543X (Linking)
VI  - 98
IP  - 8
DP  - 2003 Oct 15
TI  - A multicenter Phase I safety study of intratumoral photoactivation of talaporfin 
      sodium in patients with refractory solid tumors.
PG  - 1767-71
AB  - 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.
CI  - Copyright 2003 American Cancer Society.
FAU - Lustig, Robert A
AU  - Lustig RA
AD  - Department of Radiation Oncology, Hospital of the University of Pennsylvania, 
      Philadelphia, Pennsylvania, USA.
FAU - Vogl, Thomas J
AU  - Vogl TJ
FAU - Fromm, David
AU  - Fromm D
FAU - Cuenca, Rosa
AU  - Cuenca R
FAU - Alex Hsi, R
AU  - Alex Hsi R
FAU - D'Cruz, Anil K
AU  - D'Cruz AK
FAU - Krajina, Zdenko
AU  - Krajina Z
FAU - Turic, Marko
AU  - Turic M
FAU - Singhal, Anil
AU  - Singhal A
FAU - Chen, James C
AU  - Chen JC
LA  - eng
PT  - Clinical Trial
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Multicenter Study
PL  - United States
TA  - Cancer
JT  - Cancer
JID - 0374236
RN  - 0 (Photosensitizing Agents)
RN  - 0 (Porphyrins)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Neoplasms/*drug therapy
MH  - Photochemotherapy/*adverse effects
MH  - Photosensitizing Agents/*administration & dosage
MH  - Porphyrins/*administration & dosage
EDAT- 2003/10/10 05:00
MHDA- 2003/10/31 05:00
CRDT- 2003/10/10 05:00
PHST- 2003/10/10 05:00 [pubmed]
PHST- 2003/10/31 05:00 [medline]
PHST- 2003/10/10 05:00 [entrez]
AID - 10.1002/cncr.11708 [doi]
PST - ppublish
SO  - Cancer. 2003 Oct 15;98(8):1767-71. doi: 10.1002/cncr.11708.