Safety of PDT-Photofrin® Prior to Lung Surgery

Concordia Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Lung Cancer Metastatic; Lung Cancer

Treatments: Device: Fiber optic; Drug: Porfimer Sodium

Study type: Interventional

Funder types: Industry

Identifiers

NCT03344861

CLI-PHO1701

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Photodynamic therapy-Photofrin

Experimental group

Description:

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.

Treatment:

Device: Fiber optic

Drug: Porfimer Sodium