Safety of PDT-Photofrin® Prior to Lung Surgery

NCT ID: NCT03344861

Last Updated: 2020-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-14
• Study Completion Date: 2019-03-22

Brief Summary

This research study is being conducted to assess the safety of PDT in subjects with peripherally located malignant tumors in lung parenchyma prior to surgical resection. It will involve up to 10 sites in USA. Participation will last 4 months.

Detailed Description

Lung cancer accounts for almost one-third of cancer deaths. Cancer screening strategies have the potential to achieve a 20% reduction in death rates. Newly developed bronchoscopic technologies (such as navigational bronchoscopy) have been shown to enable physicians to safely reach lesions in peripheral regions of the lung and obtain diagnosis. This new technology may now potentially offer bronchoscopic therapeutic interventions, such as photodynamic therapy, to tumors that were previously unreachable due to their peripheral anatomic location.

Photodynamic therapy (PDT) uses a combination of a photosensitizing drug (a drug that is activated by light), called porfimer sodium (Photofrin®), and a light from a laser that emits no heat. This technique works to allow the medical doctor to specifically target and destroy abnormal or cancer cells while limiting damage to surrounding healthy tissue. The activation of the drug is done by lightning the abnormal area using a fiber optic device (very fine fiber [like a fishing line] that permits light transmission) inserted into a flexible tube with a light, called bronchoscope for the lung. The light activates the porfimer sodium concentrated in the abnormal tissue, leading to its destruction.

The purpose of this study is to assess the safety of using photodynamic therapy prior to surgical resection of tumors located in the periphery of the lung.

Conditions

Lung Cancer; Lung Cancer Metastatic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Photodynamic therapy-Photofrin

Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor.

Group Type: EXPERIMENTAL

Porfimer Sodium

Intervention Type: DRUG

Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.

Fiber optic

Intervention Type: DEVICE

After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.

Interventions

Porfimer Sodium

Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.

Intervention Type: DRUG

Fiber optic

After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.

Intervention Type: DEVICE

Other Intervention Names

Photofrin

Eligibility Criteria

Inclusion Criteria

• Male or female aged 18-79
• Diagnosed with primary or metastatic tumor < 5 cm located in peripheral lung that can be completely resectable
• Candidate for surgical resection
• Candidate for bronchoscopy
• Tumor is accessible for unrestricted illumination of PDT
• Subject is deemed likely to survive for at least 3 months
• Non-menopausal/non-sterile female subject of childbearing potential has negative B-HCG (Human chorionic gonadotropin) at time of study entry
• Non-menopausal/non-sterile female subject of childbearing potential uses medically acceptable form of birth control
• Subject is able and willing to provide written informed consent to participate in the study, which must comply with ICH (International Council for Harmonisation) guidelines & local requirements

Exclusion Criteria

• Diagnosis of small cell lung cancer or carcinoid tumors
• Primary or metastatic lung tumor located in central lung or near vertebral body
• Tumor invades a major blood vessel
• Presence of concurrent non-solid malignancy
• Tumor previously treated with radiation therapy
• Chemotherapy in the last four weeks
• Tumor treated with PDT within the last 3 months
• Abnormal blood results
• Subject with porphyria or hypersensitivity to Photofrin
• Coexisting ophthalmic disease likely to required slit-lamp exam within next 90 days
• Acute or chronic medical or psychological illness as judged clinical significant to PI to preclude bronchoscopy procedures
• female who is breast-feeding or intends to breast-feed during study
• subject who participated in another study within last 30 days or intends to participate in another study during this study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Concordia Laboratories Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erin O'Neil

Role: STUDY_CHAIR

Concordia Laboratories Inc.

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

University of Colorado

Denver, Colorado, United States

Moffitt Cancer Center

Tampa, Florida, United States

Cancer Treatment Centers of America/Southeastern

Atlanta, Georgia, United States

AMITA Health Alexian Brothers Medical Center

Elk Grove Village, Illinois, United States

Dubois Medical Center

DuBois, Pennsylvania, United States

UT MD Anderson Cancer Center

Houston, Texas, United States

Providence Health & Services

Spokane, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CLI-PHO1701

Identifier Type: -

Identifier Source: org_study_id