Non-small Cell Lung Cancer (NSCLC)Phase 1NCT02916745
Feasibility Study of Using Navigational Bronchoscopy to Perform PDT-Photofrin® in Unresectable Peripheral Lung Cancer
A Phase 1 study testing Porfimer sodium and Fiber optic in people with Non-small Cell Lung Cancer (NSCLC) and Lung Metastasis, run by Concordia Laboratories Inc. at 7 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer (NSCLC), Lung Metastasis
- What is being tested?
- Porfimer sodium and Fiber optic
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 26 Jan 2017to 12 Apr 2019
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States6 sites
Southeastern Regional Medical Center
Atlanta, Georgia, 30265
Alexian Brothers Hospital Network
Elk Grove Village, Illinois, 60007
University of Florida
Gainesville, Florida, 32611
University of Wisconsin-Madison
Madison, Wisconsin, 53715
Providence Medical Research Center
Spokane, Washington, 99204
Southwestern Regional Medical Center
Tulsa, Oklahoma, 74133
About this study
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
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.
Read the 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.
- Being tested
- Porfimer sodium, Fiber optic
- Keywords
- Non-small cell lung cancer, NSCLC, lung cancer, lung carcinoma, lung metastasis
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Porfimer sodiumDrug
Also called Photofrin
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 opticDevice
A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.
| Study group | Role | What they receive |
|---|---|---|
| Photodynamic therapy-Photofrin | Experimental | 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. Receives: Drug: Porfimer sodium; Device: Fiber optic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility to Perform Interstitial-Photodynamic Therapy (i-PDT) Into Tumor
Number of times photodynamic therapy was delivered into the tumor using navigational bronchoscopy for each subject.
Measured: Day 3 post-treatment
Adverse Events Incidence Indicating Safety of Navigational Bronchoscopy-interstitial-Photodynamic Therapy (i-PDT)
The incidence of adverse events following navigational bronchoscopy-iPDT (interstitial-Photodynamic Therapy) will be presented as the primary safety indicator for this treatment.
Measured: Up to 6 months
Secondary outcomes (23)
Tumor Response at 3 Months Post Photodynamic Therapy (PDT)
From the start of treatment until 3 months post-treatment measured as per the Modified RECIST (Response Evaluation Criteria in Solid Tumors) Criteria
Measured: Up to 3 months
Tumor Response at Study Exit (6 Months) Post Photodynamic Therapy (PDT)
From the start of treatment until 6 months post-treatment measured as per the Modified RECIST (Response Evaluation Criteria in Solid Tumors) Criteria
Measured: Up to 6 months
Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Screening (Days -14 to -1). Baseline.
Measured at screening to be the baseline measure. The Eastern Cooperative Oncology Group (ECOG) scores range from 0 to 5. The lowest values mean a better outcome: 0 is fully active with no performance restrictions; 1 is strenuous physical activity restricted but fully ambulatory and able to carry out light work; 2 is capable of all self-care but unable to carry out any work activities - up and about >50% of waking hours; 3 is capable of only limited self-care and confined to bed or chair >50% of waking hours; and 4 is completely disable, cannot carry out any self-care and totally confined to bed or chair.
Measured: up to day 0 (-14 to -1 days)
Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 1 (Date of Photofrin Injection).
Measured at Day 1 which is day of the photofrin injection. The Eastern Cooperative Oncology Group (ECOG) scores range from 0 to 5. The lowest values mean a better outcome: 0 is fully active with no performance restrictions; 1 is strenuous physical activity restricted but fully ambulatory and able to carry out light work; 2 is capable of all self-care but unable to carry out any work activities - up and about >50% of waking hours; 3 is capable of only limited self-care and confined to bed or chair >50% of waking hours; and 4 is completely disable, cannot carry out any self-care and totally confined to bed or chair.
Measured: 1 day
Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 3 (Day of Photodynamic Therapy)
Measured at Day 3. The Eastern Cooperative Oncology Group (ECOG) scores range from 0 to 5. The lowest values mean a better outcome: 0 is fully active with no performance restrictions; 1 is strenuous physical activity restricted but fully ambulatory and able to carry out light work; 2 is capable of all self-care but unable to carry out any work activities - up and about >50% of waking hours; 3 is capable of only limited self-care and confined to bed or chair >50% of waking hours; and 4 is completely disable, cannot carry out any self-care and totally confined to bed or chair.
Measured: Day 3
Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 30 (30 Days Post Photofrin Injection)
Measured at Day 3. The Eastern Cooperative Oncology Group (ECOG) scores range from 0 to 5. The lowest values mean a better outcome: 0 is fully active with no performance restrictions; 1 is strenuous physical activity restricted but fully ambulatory and able to carry out light work; 2 is capable of all self-care but unable to carry out any work activities - up and about >50% of waking hours; 3 is capable of only limited self-care and confined to bed or chair >50% of waking hours; and 4 is completely disable, cannot carry out any self-care and totally confined to bed or chair.
Measured: Day 30
Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at 3 Months Post Photofrin Injection
Measured at 3 months. The Eastern Cooperative Oncology Group (ECOG) scores range from 0 to 5. The lowest values mean a better outcome: 0 is fully active with no performance restrictions; 1 is strenuous physical activity restricted but fully ambulatory and able to carry out light work; 2 is capable of all self-care but unable to carry out any work activities - up and about >50% of waking hours; 3 is capable of only limited self-care and confined to bed or chair >50% of waking hours; and 4 is completely disable, cannot carry out any self-care and totally confined to bed or chair.
Measured: up to 3 months
Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at 6 Months Post Photofrin Injection
Measured at 6 months. The Eastern Cooperative Oncology Group (ECOG) scores range from 0 to 5. The lowest values mean a better outcome: 0 is fully active with no performance restrictions; 1 is strenuous physical activity restricted but fully ambulatory and able to carry out light work; 2 is capable of all self-care but unable to carry out any work activities - up and about >50% of waking hours; 3 is capable of only limited self-care and confined to bed or chair >50% of waking hours; and 4 is completely disable, cannot carry out any self-care and totally confined to bed or chair.
Measured: Up to 6 months
Short Form Health Survey (SF-36) Score at Baseline
The Short-Form Health Survey (SF-36) scores range from 0 to 100, with higher scores indicating better health status. SF-36 evaluates 9 dimensions of Health: physical function, role limitations due to physical health problems, body pain, general health, vitality, social functioning, role limitations due to emotional problems domain, and mental health. Summary is provided in the form of physical component score (PCS) and mental component score (MCS) for each of the timepoints.
Measured: Baseline
Short-Form Health Survey (SF-36) Score at Follow-up Visit at 3 Months.
The Short-Form Health Survey (SF-36) scores range from 0 to 100, with higher scores indicating better health status. SF-36 evaluates 9 dimensions of Health: physical function, role limitations due to physical health problems, body pain, general health, vitality, social functioning, role limitations due to emotional problems domain, and mental health. Summary is provided in the form of physical component score (PCS) and mental component score (MCS) for each of the timepoints.
Measured: up to 3 months
Short-Form Health Survey (SF-36) Score at Study Exit (6 Month Visit)
The Short-Form Health Survey (SF-36) scores range from 0 to 100, with higher scores indicating better health status. SF-36 evaluates 9 dimensions of Health: physical function, role limitations due to physical health problems, body pain, general health, vitality, social functioning, role limitations due to emotional problems domain, and mental health. Summary is provided in the form of physical component score (PCS) and mental component score (MCS) for each of the timepoints.
Measured: Up to 6 months
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
Baseline score of EORTC QLQ-C30 which is a multi-dimensional Health Related Quality of Life measure designed for use in lung cancer patients. Includes 5 functional measures (physical, role, emotional, social, cognitive), 8 symptoms (fatigue, pain, nausea/vomiting, appetite loss, constipation, diarrhea, insomnia, dyspnea) and global health status and financial impact. Most items use 4-item scale from "not at all" to "very much". Raw scores are transformed to 0-100 scale with higher scores representing better functioning/Quality of Life and greater symptom burden.
Measured: Baseline
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
3 month score of EORTC QLQ-C30 which is a multi-dimensional Health Related Quality of Life measure designed for use in lung cancer patients. Includes 5 functional measures (physical, role, emotional, social, cognitive), 8 symptoms (fatigue, pain, nausea/vomiting, appetite loss, constipation, diarrhea, insomnia, dyspnea) and global health status and financial impact. Most items use 4-item scale from "not at all" to "very much". Raw scores are transformed to 0-100 scale with higher scores representing better functioning/Quality of Life and greater symptom burden.
Measured: up to 3 months
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
6 month score of EORTC QLQ-C30 which is a multi-dimensional Health Related Quality of Life measure designed for use in lung cancer patients. Includes 5 functional measures (physical, role, emotional, social, cognitive), 8 symptoms (fatigue, pain, nausea/vomiting, appetite loss, constipation, diarrhea, insomnia, dyspnea) and global health status and financial impact. Most items use 4-item scale from "not at all" to "very much". Raw scores are transformed to 0-100 scale with higher scores representing better functioning/Quality of Life and greater symptom burden.
Measured: Up to 6 months
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
Baseline measure for EORTC QLQ-LC13 which is a 13-item lung cancer-specific questionnaire module. It is used in conjunction with the QLQ-C30. It is comprised of multi-item and single-item measures of lung cancer associated symptoms (coughing, hemoptysis, dyspnea, pain) and side effects from conventional chem-and radiotherapy (alopecia, neuropathy, sore mouth, dysphagia). For these symptom-oriented scales, a higher score means more severe symptoms. The scale is from 1 (not at all) to 4 (very much). The scoring (as reported here) is from 0 to 100 with the higher score meaning a more severe symptom.
Measured: Baseline
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
3-Month measure for EORTC QLQ-LC13 which is a 13-item lung cancer-specific questionnaire module. It is used in conjunction with the QLQ-C30. It is comprised of multi-item and single-item measures of lung cancer associated symptoms (coughing, hemoptysis, dyspnea, pain) and side effects from conventional chem-and radiotherapy (alopecia, neuropathy, sore mouth, dysphagia). For these symptom-oriented scales, a higher score means more severe symptoms. The scale is from 1 (not at all) to 4 (very much). The scoring (as reported here) is from 0 to 100 with the higher score meaning a more severe symptom.
Measured: up to 3 months
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
6-Month measure for EORTC QLQ-LC13 which is a 13-item lung cancer-specific questionnaire module. It is used in conjunction with the QLQ-C30. It is comprised of multi-item and single-item measures of lung cancer associated symptoms (coughing, hemoptysis, dyspnea, pain) and side effects from conventional chem-and radiotherapy (alopecia, neuropathy, sore mouth, dysphagia). For these symptom-oriented scales, a higher score means more severe symptoms. The scale is from 1 (not at all) to 4 (very much). The scoring (as reported here) is from 0 to 100 with the higher score meaning a more severe symptom.
Measured: Up to 6 months
Number of Participants With Indicated Adverse Events
Adverse events (AEs) noted by number of participants with at least one event. An AE was defined as any untoward medical occurrence in a subject during the course of the study, regardless of causal relationship. AEs were coded using MedDRA Version 21.1
Measured: Up to 6 months post-treatment
Number of Subjects With at Least One Serious Adverse Event
The number of subjects with at least one serious adverse event are listed.
Measured: Up to 6 months
Safety: Physical Examination Summaries for Each Subject
Safety evaluation will include the physical examinations summary of non-normal findings for each subject.
Measured: Up to 6 months
Safety: Number of Participants With Indicated Vital Sign Summaries
Safety evaluation included vital sign summary for each subject. Vital signs included pulse, blood pressure, temperature and respiration rate. Only clinically relevant results, as per the investigator judgement, are included. These would be vital signs that are out of the normal range but could be considered outside enough to be clinically relevant to the subject's health.
Measured: Up to 6 months
Safety: Number of Participants With Indicated Changes to Pulmonary Function Tests (PFTs) Related to Treatment Emergent Adverse Events
The treatment emergent adverse events related to PFTs are noted. Pulmonary function test measurements were: Diffusion Capacity of Lung for Carbon Monoxide (%), Expiratory Reserve Volume (mL), Forced Vital Capacity (mL), Forced Expiratory Volume in 1 second (mL), Forced Expiratory Flow 25% to 75% (L/min), Functional Residual Capacity (mL), Maximum Voluntary Ventilation (L/min), Residual Volume (mL), Peak Expiratory Flow (L/min), Slow Vital Capacity (mL), Total Lung Capacity (mL)
Measured: Up to 6 months
Safety: Laboratory Test Summaries for Each Subject
Safety evaluation includes laboratory tests summarized for each subject with any abnormal lab results considered an Adverse Event to be listed. The investigators commented on any laboratory value outside the normal reference range. If the value was judged to be an Adverse Event, it is listed. The values analysed were: Hematology (Hemoglobin, Hematocrit, White Blood Cell, Red Blood Cell, Platelet Count, Prothrombin Time) and Chemistry (Glucose (random), Blood Urea Nitrogen, Electrolytes (sodium, potassium, chloride), Creatinine, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase, Total Bilirubin, Albumin, Total Protein)
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2016 (estimated)
- Study start26 Jan 2017
- Primary completion12 Apr 2019
- Study completion12 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-small Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Concordia Laboratories Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michelle Depot, Ph.D., Study director, at the request of Concordia Laboratories Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02916745
- Sponsor's protocol ID
- CLI-PHO1601
- Status last verified
- Feb 2020
- First submitted
- 26 Sep 2016
- Last updated
- 4 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02916745
- Acronym / sponsor ID
- CLI-PHO1601
- Keywords
- Non-small cell lung cancer, NSCLC, lung cancer, lung carcinoma, lung metastasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Concordia Laboratories Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Jan 2017 (actual)
- Primary completion
- 12 Apr 2019 (actual)
- Study completion
- 12 Apr 2019 (actual)
- First posted
- 27 Sep 2016 (estimated)
- Results
- Posted 21 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Photodynamic therapy-Photofrin | Experimental | Drug: Porfimer sodium, Device: Fiber opticPhotodynamic 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Porfimer sodiumAlso: PhotofrinAfter 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. | Drug | Photodynamic therapy-Photofrin |
| Fiber opticA fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance. | Device | Photodynamic therapy-Photofrin |
Primary outcome
Feasibility to Perform Interstitial-Photodynamic Therapy (i-PDT) Into Tumor
Time frame: Day 3 post-treatment
Number of times photodynamic therapy was delivered into the tumor using navigational bronchoscopy for each subject.
Adverse Events Incidence Indicating Safety of Navigational Bronchoscopy-interstitial-Photodynamic Therapy (i-PDT)
Time frame: Up to 6 months
The incidence of adverse events following navigational bronchoscopy-iPDT (interstitial-Photodynamic Therapy) will be presented as the primary safety indicator for this treatment.
23 secondary outcomes
Tumor Response at 3 Months Post Photodynamic Therapy (PDT)
Time frame: Up to 3 months
Tumor Response at Study Exit (6 Months) Post Photodynamic Therapy (PDT)
Time frame: Up to 6 months
Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Screening (Days -14 to -1). Baseline.
Time frame: up to day 0 (-14 to -1 days)
Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 1 (Date of Photofrin Injection).
Time frame: 1 day
Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 3 (Day of Photodynamic Therapy)
Time frame: Day 3
Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 30 (30 Days Post Photofrin Injection)
Time frame: Day 30
Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at 3 Months Post Photofrin Injection
Time frame: up to 3 months
Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at 6 Months Post Photofrin Injection
Time frame: Up to 6 months
Short Form Health Survey (SF-36) Score at Baseline
Time frame: Baseline
Short-Form Health Survey (SF-36) Score at Follow-up Visit at 3 Months.
Time frame: up to 3 months
Short-Form Health Survey (SF-36) Score at Study Exit (6 Month Visit)
Time frame: Up to 6 months
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
Time frame: Baseline
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
Time frame: up to 3 months
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
Time frame: Up to 6 months
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
Time frame: Baseline
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
Time frame: up to 3 months
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
Time frame: Up to 6 months
Number of Participants With Indicated Adverse Events
Time frame: Up to 6 months post-treatment
Number of Subjects With at Least One Serious Adverse Event
Time frame: Up to 6 months
Safety: Physical Examination Summaries for Each Subject
Time frame: Up to 6 months
Safety: Number of Participants With Indicated Vital Sign Summaries
Time frame: Up to 6 months
Safety: Number of Participants With Indicated Changes to Pulmonary Function Tests (PFTs) Related to Treatment Emergent Adverse Events
Time frame: Up to 6 months
Safety: Laboratory Test Summaries for Each Subject
Time frame: Up to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Depot, Ph.D. study director
at the request of Concordia Laboratories Inc.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Porfimer sodium and Fiber optic in people with Non-small Cell Lung Cancer (NSCLC) and Lung Metastasis, run by Concordia Laboratories Inc. at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility to Perform Interstitial-Photodynamic Therapy (i-PDT) Into Tumor (time frame: Day 3 post-treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2020.