Safety of Photodynamic Therapy (PDT) in the Ablation of High-grade Dysplasia (HGD) in Barrett's Esophagus (BE)

NCT01209013 | Withdrawn Phase 3

• 1 other identifier: MA-PO-PHOEST07-01
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Photodynamic therapy (PDT) uses a combination of a drug, porfimer sodium, and a light from a non heated laser. The activation of the drug is done by lighting of abnormal areas using a fiber optic device. The fiber optic device is a very fine fiber (like a fishing line) that permits transmission of light. The fiber optic device is inserted into a diffusing balloon device to ensure the good positioning of the fiber optic within the esophagus (food pipe). It is thought that the size and the flexibility of a new diffusing balloon device could improve the safety profile of the photodynamic treatment by reducing the risk of narrowing or closure of the food pipe (esophageal stenosis) sometimes occurring after treatment. This research study will evaluate the safety and effectiveness of PDT with porfimer sodium using a new diffusing balloon device for light application in the removal of high-grade dysplasia (HGD, precancerous change in the food pipe tissue) in Barrett's esophagus (BE). This study will provide advanced knowledge about phototoxicity (reaction similar to sunburn) and esophageal stenosis, main risks with this therapy. It will involve 75 patients with HGD in BE across North America and Europe and will last between 13 and 16 weeks. In addition, concentrations of porfimer sodium in the esophageal tissue will be analyzed in a subgroup of patients.

Conditions

Barrett Esophagus

Keywords

PDT; porfimer sodium; BE

Outcome Measures

Primary Outcomes (2)

• Incidence of phototoxicity reaction

  3 months

• Incidence of esophageal stenosis

  3 months

Secondary Outcomes (3)

• Proportion of patients with complete ablation (removal) of high-grade dysplasia

  3 months

• Proportion of patients with adverse events as a measure of safety

  3 months

• Measure oligomer concentrations

  3 months

Study Arms (1)

Medlight PDT Balloon

EXPERIMENTAL

Device: Medlight PDT Balloon; Procedure: Endoscopy; Procedure: Endoscopy with biopsy; Procedure: Electrocardiogram; Procedure: Chest x-ray; Procedure: Blood collection; Procedure: Tissue sample collection

Interventions

Medlight PDT Balloon DEVICE

Medlight PDT Balloon will be used once to apply the laser light treatment

Medlight PDT Balloon

Endoscopy PROCEDURE

Endoscopy will be performed to confirm eligibility, apply photodynamic therapy, assess esophageal condition and effectiveness of the therapy

Medlight PDT Balloon

Endoscopy with biopsy PROCEDURE

Endoscopy with collection of esophageal tissue will be performed at screening to confirm eligibility and at Week 13 (final visit) to assess effectiveness

Medlight PDT Balloon

Electrocardiogram PROCEDURE

Resting electrocardiogram will be performed at screening (unless one has been performed within 30 days prior to screening) to measure heart function

Medlight PDT Balloon

Chest x-ray PROCEDURE

A chest X-ray will be performed at screening (unless one has been performed within 90 days prior to screening) to provide several pictures of the chest to rule out any lung abnormalities

Medlight PDT Balloon

Blood collection PROCEDURE

Blood samples for laboratory tests will be taken to assess the overall condition

Medlight PDT Balloon

Tissue sample collection PROCEDURE

Esophageal tissue samples will be collected before the porfimer sodium injection and on four separate occasions after the injection (22-26 hour-, 40-50 hour-, 96-120 hour-intervals, and 13 weeks) to measure concentrations of oligomers in a subgroup of 12 patients.

Medlight PDT Balloon

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients are males or females aged 18 or older.
• Patients have been diagnosed with biopsy-proven HGD in BE.
• Non-menopausal or non-surgically sterilized female patients must have a negative serum beta-HCG at the time of entry into the study.
• Non-menopausal or non-surgically sterilized female patients must use a medically acceptable form of birth control.
• Patients must sign an Informed Consent Form, which must comply with the ICH guidelines and local requirements.

You may not qualify if:

• Patients who have previously received PDT for HGD in BE.
• Patients who have previously undergone radiation therapy to the chest.
• Patients with known porphyria or known hypersensitivity to porphyrins or any excipients of the porfimer sodium.
• Patients who have esophageal cancer or in whom esophageal cancer, lymph node involvement, or metastases cannot be ruled out based on the pathology report, endoscopic ultrasonography (EUS), computed tomography (CT) scan or other diagnostic methods used in current practice no more than 30 days prior to date of consent.
• Patients with any acute or chronic medical or psychological illnesses as judged clinically significant by the investigator to preclude PDT procedure.
• Patients with a presence or history of neoplasms (treated during the last five years prior to study entry) other than carcinoma in situ of the cervix or basal carcinoma of the skin.
• Patients with esophageal strictures, esophageal diverticula, esophageal or gastric varices.
• Patients with known contraindications to analgesia or endoscopy.
• Patients with blood parameters of Grade 3 or higher on the Common Terminology Criteria for Adverse Events (CTCAE).
• Patients with unstable cardiovascular disease (Class III and IV cardiovascular disease according to the New York Heart Association's functional criteria).
• Patients with esophageal ulcers \> 1 cm in diameter.
• Patients with tracheoesophageal or bronchoesophageal fistula.
• Patients with chronic/acute dermatologic conditions (e.g., urticaria, eczema, sunburn).
• Patients under anticoagulant therapy (only for the subgroup of 12 patients who will consent to provide tissue samples in order to determine the concentrations of oligomers).
• Patients with severe renal or hepatic impairment with parameters of Grade 3 or higher on the CTCAE.

Sponsors & Collaborators

• Pinnacle Biologics Inc.: lead

MeSH Terms

Conditions

Barrett Esophagus

Interventions

Endoscopy; Biopsy; X-Rays; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Specimen Handling; Investigative Techniques; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing; Punctures

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2010
• First Posted: September 24, 2010
• Last Updated: May 8, 2012

Record last verified: 2012-05