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Safety of PDT-Photofrin® Prior to Lung Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03344861
Recruitment Status : Completed
First Posted : November 17, 2017
Results First Posted : January 2, 2020
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Concordia Laboratories Inc.

Tracking Information
First Submitted Date  ICMJE November 13, 2017
First Posted Date  ICMJE November 17, 2017
Results First Submitted Date  ICMJE October 26, 2019
Results First Posted Date  ICMJE January 2, 2020
Last Update Posted Date January 13, 2020
Actual Study Start Date  ICMJE August 14, 2017
Actual Primary Completion Date March 22, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 30, 2019)
  • Safety: Number of Participants With at Least One Adverse Event [ Time Frame: 108 days (to 3 months post surgery) ]
    Safety evaluation will include incidence of all adverse events, including serious and non-serious. The count of how many subjects experienced at least one adverse event.
  • Safety: Physical Examination Summaries of Non-normal Findings for Each Subject [ Time Frame: 108 days (to 3 months post surgery) ]
    Safety evaluation will include the physical examinations summary of non-normal findings for each subject.
  • Safety: Vital Sign Summary of Abnormal Findings for Each Subject [ Time Frame: 108 days (to 3 months post surgery) ]
    Safety evaluation will include vital sign summary for each subject. Only abnormal counts are included.
  • Safety: Laboratory Tests Summaries of Abnormal Findings for Each Subject [ Time Frame: 108 days (to 3 months post surgery) ]
    Safety evaluation will include laboratory tests summarized for each subject with any abnormal lab results considered an AE (adverse event) to be listed.
  • Safety: Skin Photosensitivity Events Summaries of Abnormal Findings for Each Subject [ Time Frame: 108 days (to 3 months post surgery) ]
    Safety evaluation will include incidence of skin photosensitivity summarized for each subject.
Original Primary Outcome Measures  ICMJE
 (submitted: November 15, 2017)
Proportion of patients with serious and non-serious adverse events [ Time Frame: Up to 6 months ]
Safety evaluation will include incidence of adverse events.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 6, 2019)
  • Macroscopic Tissue Examination [ Time Frame: Day 13 to 18 ]
    The mean measurement of tumor size after surgery. The largest diameter seen is measured.
  • Summary of Microscopic Tissue Examination: Percentage of Participants With Complete Response After Surgery [ Time Frame: Day 13 to 18 ]
    The Percentage of Participants with Complete Response in Tumor area (no non-viable/necrotic tumor) after surgery
  • Microscopic Tissue Examination: Percent Tumor Cell Necrosis in Tumor Area After Surgery [ Time Frame: Day 13 to 18 ]
    The mean with standard deviation of the percent of tumor cell necrosis in the tumor area after surgery. The tumor itself was examined after it was removed to determine the percent of necrosis seen.
  • Microscopic Tissue Examination: Brisk Inflammatory Reaction After Surgery [ Time Frame: Day 13 to 18 ]
    The number of participants showing a brisk inflammatory reaction in the tumor area after surgery. This is determined through a histological examination. Brisk Inflammatory Reaction is defined as lymphocytes that infiltrate diffusely the entire tumor and/or infiltrate across the entire base of the tumor.
  • Microscopic Tissue Examination: Number of Participants With Cavitation in Normal Lung Area After Surgery [ Time Frame: Day 13 to 18 ]
    The number of participants with cavitation seen in the normal lung area from the microscopic tissue examination after surgery
  • Microscopic Tissue Examination: Number of Participants With Hemorrhage Seen After Surgery [ Time Frame: Day 13 to 18 ]
    The Number of Participants with hemorrhage seen during the microscopic tissue examination after surgery
  • Microscopic Tissue Examination: Number of Participants With Pneumonitis in the Normal Lung After Surgery [ Time Frame: Day 13 to 18 ]
    The Number of Participants with pneumonitis seen in the normal lung area after surgery following the microscopic tissue examination
  • Microscopic Tissue Examination: Number of Participants With Increased Alveolar Macrophages in the Normal Lung After Surgery [ Time Frame: Day 13 to 18 ]
    The number of participants with increased alveolar macrophages post surgery determined in the microscopic tissue examination.
  • Microscopic Tissue Examination: Number of Participants With Atypical/Reactive Type 2 Pneumocytes in the Normal Lung After Surgery [ Time Frame: Day 13 to 18 ]
    Number of Participants with Atypical/Reactive Type 2 pneumocytes seen in the normal lung after surgery during the Microscopic Tissue Examination:
  • Microscopic Tissue Examination: Number of Participants With Mucus Plugging/Mucositis in the Normal Lung After Surgery [ Time Frame: Day 13 to 18 ]
    Number of Participants with Mucus Plugging/Mucositis seen in the normal lung after surgery during the Microscopic Tissue Examination.
  • Microscopic Tissue Examination: Number of Participants With Interstitial Fibrosis in the Normal Lung After Surgery [ Time Frame: Day 13 to 18 ]
    Number of participants with interstitial fibrosis in the normal lung after surgery seen during the Microscopic Tissue Examination
  • Microscopic Tissue Examination: Number of Participants With Necrosis in the Normal Lung After Surgery [ Time Frame: Day 13 to 18 ]
    Number of Participants with Necrosis seen in the normal lung after surgery during the Microscopic Tissue Examination
  • Microscopic Tissue Examination: Number of Participants With Large Vessel Damage Indicated by Fibrinoid Necrosis, Thrombus, Vasculitis in the Normal Lung After Surgery [ Time Frame: Day 13 to 18 ]
    Number of Participants with Large Vessel Damage indicated by fibrinoid necrosis, thrombus, vasculitis in the normal lung after surgery seen during Microscopic Tissue Examination
  • Microscopic Tissue Examination: Number of Participants With Acute Alveolar Damage in the Normal Lung After Surgery [ Time Frame: Day 13 to 18 ]
    Number of Participants with Acute Alveolar damage in the normal lung after surgery seen during the Microscopic Tissue Examination
  • Microscopic Tissue Examination: Number of Participants With Organizing Pneumonia Pattern in the Normal Lung After Surgery [ Time Frame: Day 13 to 18 ]
    Number of Participants with Organizing pneumonia pattern in the normal lung after surgery seen during Microscopic Tissue Examination
  • ECOG (Eastern Cooperative Oncology Group) Performance Status: Baseline [ Time Frame: Baseline (-30 to -1 Days) ]
    Number of Participants with ECOG Performance at Baseline showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead).
  • ECOG Performance Status: Period 1 PDT Day 3 [ Time Frame: Day 3 ]
    Number of Participants with ECOG Performance Status at Period 1 PDT Day 3, showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead).
  • ECOG Performance Status: Period II Surgery (Day 13-18) [ Time Frame: Day 13 to 18 ]
    Number of Participants with ECOG Performance Status at Period II Surgery (Day 13-18) showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead).
  • ECOG Performance Status: Period III Follow-up (Day 20-25) [ Time Frame: Day 20 to 25 ]
    Number of Participants with ECOG Performance Status at Period III Follow-up (Day 20-25) showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead).
  • ECOG Performance Status: Period III Follow-up (Day 43 -48) [ Time Frame: Day 43 to 48 ]
    Number of Participants with ECOG Performance Status at Period III Follow-up (Day 43 -48) showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead).
  • ECOG Performance Status: Period III Follow-up (Day 103 - 108) [ Time Frame: 108 days (to 3 months post surgery) ]
    Number of Participants with ECOG Performance Status at Period III Follow-up (Day 103 - 108) showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead).
Original Secondary Outcome Measures  ICMJE
 (submitted: November 15, 2017)
Histological tissue response [ Time Frame: Day 13 ]
Macroscopic and microscopic examinations will be tabulated and summarized for tumor tissue and healthy tissue
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety of PDT-Photofrin® Prior to Lung Surgery
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Lung Cancer
  • Lung Cancer Metastatic
Intervention  ICMJE
  • Drug: Porfimer Sodium
    Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.
    Other Name: Photofrin
  • Device: 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.
Study Arms  ICMJE Experimental: 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.
Interventions:
  • Drug: Porfimer Sodium
  • Device: Fiber optic
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 15, 2017)
10
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 22, 2019
Actual Primary Completion Date March 22, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03344861
Other Study ID Numbers  ICMJE CLI-PHO1701
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: This is a phase 2 study with only 10 subjects which is of minor use to other researchers.
Responsible Party Concordia Laboratories Inc.
Study Sponsor  ICMJE Concordia Laboratories Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Erin O'Neil Concordia Laboratories Inc.
PRS Account Concordia Laboratories Inc.
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP