Feasibility Study of Using Navigational Bronchoscopy to Perform PDT-Photofrin® in Unresectable Peripheral Lung Cancer

NCT ID: NCT02916745

Last Updated: 2020-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-26
• Study Completion Date: 2019-04-12

Brief Summary

This research study is being conducted to assess the safety and feasibility of using a new developed bronchoscopic technology called electronavigational bronchoscopy to treat subjects with solid tumor in peripheral lung, who are inoperable or refused surgery. It will involve 10 sites in USA and Canada. Participation will last 6 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 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 lighting the abnormal area using a fiber optic device (very fine fiber [like a fishing line] that permits light transmission) inserted into a flexible tube called bronchoscope. The light activates the porfimer sodium, which is concentrated in the abnormal tissue, leading to its destruction.

The purpose of this study is to determine if physicians can reach the tumors in the periphery of the lung via electronavigational bronchoscopy and deliver the photodynamic therapy by placing the optical fiber into the tumor.

Conditions

Non-small Cell Lung Cancer (NSCLC); Lung Metastasis

Study Design

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

Study Groups

Photodynamic therapy-Photofrin

Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor.

Group Type: EXPERIMENTAL

Porfimer sodium

Intervention Type: DRUG

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). A light dose of 200 J/cm of diffuser length will be delivered.

Fiber optic

Intervention Type: DEVICE

A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.

Interventions

Porfimer sodium

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). A light dose of 200 J/cm of diffuser length will be delivered.

Intervention Type: DRUG

Fiber optic

A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.

Intervention Type: DEVICE

Other Intervention Names

Photofrin

Eligibility Criteria

Inclusion Criteria

• Male or female aged 18 or older
• Diagnosed with histologically confirmed solid tumor located in the peripheral lung
• Not candidate for curative surgery, is unfit for surgery, or does not wish to undergo curative surgery
• May be candidate for, have failed, or does not wish to undergo radiation therapy
• The tumor is ≤ 3 cm in size and clearly observable in computerized tomography (CT scan)
• Able to sign an informed consent

Exclusion Criteria

• Diagnostic of small cell lung cancer
• Solid tumor located in central lung
• Presence of concurrent non-solid malignancy
• Abnormal blood results
• Received chemotherapy/immunotherapy in the last 4 weeks
• Tumor invades a major blood vessel
• Porphyria or known hypersensitivity to Photofrin® or porphyrin-like compounds or to any of its excipients
• Planned surgical procedure within the next 90 days
• Coexisting ophthalmic disease likely to require slit-lamp examination within the next 90 days
• Acute or chronic medical or psychological illnesses that prevent endoscopy procedures
• Pregnant or intend to become pregnant, breastfeeding or intend to breastfeed during the study
• Received PDT during the past 3 months
• Severe impairment of your kidney or liver function
• Participates or intends to participate in another drug study (other than observational studies) during the study

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

Sponsors

Concordia Laboratories Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michelle Depot, Ph.D.

Role: STUDY_DIRECTOR

at the request of Concordia Laboratories Inc.

Locations

University of Florida

Gainesville, Florida, United States

Southeastern Regional Medical Center

Atlanta, Georgia, United States

Alexian Brothers Hospital Network

Elk Grove Village, Illinois, United States

Southwestern Regional Medical Center

Tulsa, Oklahoma, United States

Providence Medical Research Center

Spokane, Washington, United States

University of Wisconsin-Madison

Madison, Wisconsin, United States

Toronto General Hospital

Toronto, Ontario, Canada

Countries

United States; Canada

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CLI-PHO1601

Identifier Type: -

Identifier Source: org_study_id