A Phase II safety and effect on time to tumor progression study of intratumoral light infusion technology using talaporfin sodium in patients with metastatic colorectal cancer.
OBJECTIVE
Twenty-seven patients with refractory liver metastases from colorectal cancer took part in a Phase II study of the light infusion technology (Litx) light-activated drug/device system to assess safety and evaluate time to tumor progression (TTP).


METHODS
Litx consists of the light-activated drug, talaporfin sodium (LS11), activated intratumorally by a catheter-like array of light-emitting diodes (LEDs). After placement of the array via ultrasound or computed tomography (CT) guidance, LS11 was administered intravenously, followed 15-60 min later by light infusion for 2.8 hr. Patients were assessed for adverse events and tumor response using physical examination, laboratory values, and CT scan evaluation over a period of 60 days.


RESULTS
The observed occurrence of Litx treatment-related adverse events was minimal and cumulative toxicity did not occur when combined with chemotherapy. Assessment of TTP and tumor response rate, although statistically non-robust, suggest potential improvement.


CONCLUSIONS
The Litx system was shown to be safe for treating liver metastases from colorectal cancer and there was no cumulative toxicity when combined with standard systemic therapy. Preliminary assessments of TTP and tumor response rate justify further evaluation in a Phase III follow-up study.
Department of Medicine, Division of Gastroenterology, University Hospital Dubrava, Zagreb, Croatia.
M
M
Kujundzić
T J
TJ
Vogl
D
D
Stimac
N
N
Rustemović
R Alex
RA
Hsi
M
M
Roh
M
M
Katicić
R
R
Cuenca
R A
RA
Lustig
S
S
Wang
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D015179:Colorectal Neoplasms / Q000473:pathology*; D003131:Combined Modality Therapy; D018450:Disease Progression; D005260:Female; D006801:Humans; D008113:Liver Neoplasms / Q000556:secondary / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D017319:Photosensitizing Agents / Q000627:therapeutic use*; D010789:Phototherapy / Q000009:adverse effects / Q000379:methods*; D011166:Porphyrins / Q000276:immunology / Q000627:therapeutic use*; D013997:Time Factors
D000970:Antineoplastic Agents; D017319:Photosensitizing Agents; D011166:Porphyrins; C053434:Talaporfin