Clinical trial NCT03344861: Safety of PDT-Photofrin® Prior to Lung Surgery
Official title: A Multicenter, Prospective, Open-label, Non-randomized Single-arm Clinical Study of the Safety and Tissue Response to Photodynamic Therapy Using Porfimer Sodium for Injection as Treatment for Solid Lung Tumor Prior to Surgical Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lung Cancer
Lung Cancer Metastatic
Keywords: lung cancer
lung carcinoma
lung metastases
Lead sponsor: Concordia Laboratories Inc.
Sponsor class: INDUSTRY
First posted: 2017-11-17
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Safety: Number of Participants With at Least One Adverse Event
timeFrame: 108 days (to 3 months post surgery)
measure: Safety: Physical Examination Summaries of Non-normal Findings for Each Subject
timeFrame: 108 days (to 3 months post surgery)
measure: Safety: Vital Sign Summary of Abnormal Findings for Each Subject
timeFrame: 108 days (to 3 months post surgery)
measure: Safety: Laboratory Tests Summaries of Abnormal Findings for Each Subject
timeFrame: 108 days (to 3 months post surgery)
measure: Safety: Skin Photosensitivity Events Summaries of Abnormal Findings for Each Subject
timeFrame: 108 days (to 3 months post surgery)
Secondary outcomes:
measure: Macroscopic Tissue Examination
timeFrame: Day 13 to 18
measure: Summary of Microscopic Tissue Examination: Percentage of Participants With Complete Response After Surgery
timeFrame: Day 13 to 18
measure: Microscopic Tissue Examination: Percent Tumor Cell Necrosis in Tumor Area After Surgery
timeFrame: Day 13 to 18
measure: Microscopic Tissue Examination: Brisk Inflammatory Reaction After Surgery
timeFrame: Day 13 to 18
measure: Microscopic Tissue Examination: Number of Participants With Cavitation in Normal Lung Area After Surgery
timeFrame: Day 13 to 18
measure: Microscopic Tissue Examination: Number of Participants With Hemorrhage Seen After Surgery
timeFrame: Day 13 to 18
measure: Microscopic Tissue Examination: Number of Participants With Pneumonitis in the Normal Lung After Surgery
timeFrame: Day 13 to 18
measure: Microscopic Tissue Examination: Number of Participants With Increased Alveolar Macrophages in the Normal Lung After Surgery
timeFrame: Day 13 to 18
measure: Microscopic Tissue Examination: Number of Participants With Atypical/Reactive Type 2 Pneumocytes in the Normal Lung After Surgery
timeFrame: Day 13 to 18
measure: Microscopic Tissue Examination: Number of Participants With Mucus Plugging/Mucositis in the Normal Lung After Surgery
timeFrame: Day 13 to 18
measure: Microscopic Tissue Examination: Number of Participants With Interstitial Fibrosis in the Normal Lung After Surgery
timeFrame: Day 13 to 18
measure: Microscopic Tissue Examination: Number of Participants With Necrosis in the Normal Lung After Surgery
timeFrame: Day 13 to 18
measure: Microscopic Tissue Examination: Number of Participants With Large Vessel Damage Indicated by Fibrinoid Necrosis, Thrombus, Vasculitis in the Normal Lung After Surgery
timeFrame: Day 13 to 18
measure: Microscopic Tissue Examination: Number of Participants With Acute Alveolar Damage in the Normal Lung After Surgery
timeFrame: Day 13 to 18
measure: Microscopic Tissue Examination: Number of Participants With Organizing Pneumonia Pattern in the Normal Lung After Surgery
timeFrame: Day 13 to 18
measure: ECOG (Eastern Cooperative Oncology Group) Performance Status: Baseline
timeFrame: Baseline (-30 to -1 Days)
measure: ECOG Performance Status: Period 1 PDT Day 3
timeFrame: Day 3
measure: ECOG Performance Status: Period II Surgery (Day 13-18)
timeFrame: Day 13 to 18
measure: ECOG Performance Status: Period III Follow-up (Day 20-25)
timeFrame: Day 20 to 25
measure: ECOG Performance Status: Period III Follow-up (Day 43 -48)
timeFrame: Day 43 to 48
measure: ECOG Performance Status: Period III Follow-up (Day 103 - 108)
timeFrame: 108 days (to 3 months post surgery)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Denver
country: United States
facility: University of Colorado
state: Colorado
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Atlanta
country: United States
facility: Cancer Treatment Centers of America/Southeastern
state: Georgia
city: Elk Grove Village
country: United States
facility: AMITA Health Alexian Brothers Medical Center
state: Illinois
city: DuBois
country: United States
facility: Dubois Medical Center
state: Pennsylvania
city: Houston
country: United States
facility: UT MD Anderson Cancer Center
state: Texas
city: Spokane
country: United States
facility: Providence Health & Services
state: Washington
Study officials:
affiliation: Concordia Laboratories Inc.
name: Erin O'Neil
role: STUDY_CHAIR
References: