Clinical trial NCT02916745: Feasibility Study of Using Navigational Bronchoscopy to Perform PDT-Photofrin® in Unresectable Peripheral Lung Cancer
Official title: Multicenter, Prospective, OL, Single-arm Clinical Study of Safety & Feasibility of Using Navigational Bronchoscopy to Perform Interstitial PD Therapy Using Photofrin® as Treatment in Subjects With Unresectable Solid Tumor in Peripheral Lung
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non-small Cell Lung Cancer (NSCLC)
Lung Metastasis
Keywords: Non-small cell lung cancer
NSCLC
lung cancer
lung carcinoma
lung metastasis
Lead sponsor: Concordia Laboratories Inc.
Sponsor class: INDUSTRY
First posted: 2016-09-27
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Feasibility to Perform Interstitial-Photodynamic Therapy (i-PDT) Into Tumor
timeFrame: Day 3 post-treatment
measure: Adverse Events Incidence Indicating Safety of Navigational Bronchoscopy-interstitial-Photodynamic Therapy (i-PDT)
timeFrame: Up to 6 months
Secondary outcomes:
measure: Tumor Response at 3 Months Post Photodynamic Therapy (PDT)
timeFrame: Up to 3 months
measure: Tumor Response at Study Exit (6 Months) Post Photodynamic Therapy (PDT)
timeFrame: Up to 6 months
measure: Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Screening (Days -14 to -1). Baseline.
timeFrame: up to day 0 (-14 to -1 days)
measure: Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 1 (Date of Photofrin Injection).
timeFrame: 1 day
measure: Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 3 (Day of Photodynamic Therapy)
timeFrame: Day 3
measure: Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 30 (30 Days Post Photofrin Injection)
timeFrame: Day 30
measure: Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at 3 Months Post Photofrin Injection
timeFrame: up to 3 months
measure: Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at 6 Months Post Photofrin Injection
timeFrame: Up to 6 months
measure: Short Form Health Survey (SF-36) Score at Baseline
timeFrame: Baseline
measure: Short-Form Health Survey (SF-36) Score at Follow-up Visit at 3 Months.
timeFrame: up to 3 months
measure: Short-Form Health Survey (SF-36) Score at Study Exit (6 Month Visit)
timeFrame: Up to 6 months
measure: Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Baseline
timeFrame: Baseline
measure: Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Follow-up 3 Months
timeFrame: up to 3 months
measure: Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): 6 Months
timeFrame: Up to 6 months
measure: Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Baseline Score
timeFrame: Baseline
measure: Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Follow-up 3 Month Score
timeFrame: up to 3 months
measure: Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Study Exit (6 Months) Score
timeFrame: Up to 6 months
measure: Number of Participants With Indicated Adverse Events
timeFrame: Up to 6 months post-treatment
measure: Number of Subjects With at Least One Serious Adverse Event
timeFrame: Up to 6 months
measure: Safety: Physical Examination Summaries for Each Subject
timeFrame: Up to 6 months
measure: Safety: Number of Participants With Indicated Vital Sign Summaries
timeFrame: Up to 6 months
measure: Safety: Number of Participants With Indicated Changes to Pulmonary Function Tests (PFTs) Related to Treatment Emergent Adverse Events
timeFrame: Up to 6 months
measure: Safety: Laboratory Test Summaries for Each Subject
timeFrame: Up to 6 months
Other outcomes:
measure: Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported.
timeFrame: Baseline, 10 days post-treatment
measure: Skin Photosensitivity as a Adverse Event of Special Interest: Participants With Event
timeFrame: Up to 6 months
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Atlanta
country: United States
facility: Southeastern Regional Medical Center
state: Georgia
city: Elk Grove Village
country: United States
facility: Alexian Brothers Hospital Network
state: Illinois
city: Tulsa
country: United States
facility: Southwestern Regional Medical Center
state: Oklahoma
city: Spokane
country: United States
facility: Providence Medical Research Center
state: Washington
city: Madison
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
affiliation: at the request of Concordia Laboratories Inc.
name: Michelle Depot, Ph.D.
role: STUDY_DIRECTOR
References: