Case Analysis on Real Life Incidence of Photodynamic Therapy (PDT) Safety Outcomes (CALIPSO)

Case Analysis on Real Life Incidence of PDT Safety Outcomes: Multicentre, Observational Post-marketing Safety Surveillance Registry of Patients Exposed to Photodynamic Therapy With Porfimer Sodium: The CALIPSO Registry

Three main adverse reactions, namely photosensitivity (reaction that is similar to sunburn), oesophageal stenosis (narrowing or closure of the food pipe), perforation of the treated area (a tear or puncture of the tissue), have been identified in research studies evaluating photodynamic therapy (PDT) with porfimer sodium. Because of the low incidence of the disease or the variation in the occurrence of these adverse reactions among different indications, it is difficult to determine the occurrence and frequency of these safety issues in routine clinical practice.

This post-marketing safety surveillance registry is set-up to evaluate the safety of PDT using porfimer sodium. A registry allows the collection of data to evaluate real-world results in the practice of medicine. The registry will monitor the patient's health and any events, with a main focus on photosensitivity, oesophageal stenosis, and perforation of the treated area. This registry will involve 500 patients, across 20 to 36 hospitals in the US and Europe, scheduled to receive an injection of porfimer sodium with PDT for the treatment of lung cancer, esophageal [food pipe] cancer, or high-grade dysplasia (HGD) (precancerous change in the food pipe tissue) in Barrett's esophagus.

Study Overview

• Status: Withdrawn
• Conditions: Esophageal Cancer; Lung Cancer; Barrett's Esophagus

Detailed Description

Patients will be enrolled in the registry upon injection of the porfimer sodium. During normal medical examination, criteria for entry onto the registry will be verified to confirm eligibility, and medical procedures including demographic information, disease history, medical history, physical exam, and clinical laboratory testing performed under normal practice will be collected. Patients will receive PDT as per current practice and will be repeated as per the physician's judgment. All patients will be assessed as per current practice, that is usually at least three times, after a PDT session. Additional visits will be sought for those patients who are presenting photosensitivity reaction, esophageal stenosis, perforation at the site of laser light application, or any unresolved serious adverse reactions at the third visit after treatment. All patients will be requested by their physician to complete a two-part Daily Diary to record adverse reactions using a check-list form and a general section for reporting any adverse events and intake of concomitant medications at the time of the adverse event.

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients suffering from esophageal cancer, lung cancer, or HGD in Barrett's esophagus and scheduled to undergo PDT with porfimer sodium

Description

Inclusion Criteria:

• Patients scheduled to undergo PDT with Photofrin
• Patients must have the mental, literate, and legal ability to give a written informed consent, which must comply with the International Conference on Harmonization (ICH) guidelines and local requirements.

Exclusion Criteria:

• Patients treated with Photosan®
• Patients being treated with any investigational drug or participating in any interventional studies, with the exception of investigational photoprotection measures.
• Patients who are unable or unwilling to complete the follow-up evaluations required for the registry.

Study Plan

How is the study designed?

Design Details

• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
PDT with porfimer sodium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients experiencing Adverse Reactions of Special Interest	Proportion of patients experiencing photosensitivity reaction, oesophageal stenosis, and/or perforation at the site of laser light application after PDT.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of the photosensitivity reaction in patients with liver insufficiency (disease)	Possible differences in the incidence of the photosensitivity reaction between patients with and without liver insufficiency	3 months
Relationships between photosensitivity reaction and skin color		3 months
Overall safety in patients with renal insufficiency (disease)		3 months

Collaborators and Investigators

• Sponsor: Pinnacle Biologics Inc.

Study record dates

Study Registration Dates

• First Submitted: September 15, 2010
• First Submitted That Met QC Criteria: September 15, 2010
• First Posted (Estimate): September 16, 2010

Study Record Updates

• Last Update Posted (Estimate): May 9, 2012
• Last Update Submitted That Met QC Criteria: May 7, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: NSCLC; esophageal cancer; PDT; porfimer sodium; HGD in BE
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Precancerous Conditions; Esophageal Neoplasms; Barrett Esophagus
• Other Study ID Numbers: MA-PO-PHORC07-01