Phase 1
N=5
Feasibility Study of Using Navigational Bronchoscopy to Perform PDT-Photofrin® in Unresectable Peripheral Lung Cancer
Non-small Cell Lung Cancer (NSCLC) · Lung Metastasis
Bottom Line
View on ClinicalTrials.gov: NCT02916745 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: Feasibility to Perform Interstitial-Photodynamic Therapy (i-PDT) Into Tumor — 3; 0; 1; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Porfimer sodium (Drug); Fiber optic (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Concordia Laboratories Inc.
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility to Perform Interstitial-Photodynamic Therapy (i-PDT) Into Tumor |
3; 0; 1; 1 | — |
| PRIMARY Adverse Events Incidence Indicating Safety of Navigational Bronchoscopy-interstitial-Photodynamic Therapy (i-PDT) |
5; 2; 2; 2; 3; 3 | — |
| SECONDARY Tumor Response at 3 Months Post Photodynamic Therapy (PDT) |
1; 0; 4; 0; 1 | — |
| SECONDARY Tumor Response at Study Exit (6 Months) Post Photodynamic Therapy (PDT) |
1; 0; 3; 1; 1 | — |
| SECONDARY Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Screening (Days -14 to -1). Baseline. |
1; 2; 2; 0; 0; 0 | — |
| SECONDARY Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 1 (Date of Photofrin Injection). |
1; 4; 0; 0; 0; 0 | — |
| SECONDARY Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 3 (Day of Photodynamic Therapy) |
0; 3; 1; 0; 0; 0 | — |
| SECONDARY Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 30 (30 Days Post Photofrin Injection) |
1; 2; 2; 0; 0; 0 | — |
| SECONDARY Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at 3 Months Post Photofrin Injection |
2; 2; 1; 0; 0; 0 | — |
| SECONDARY Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at 6 Months Post Photofrin Injection |
3; 1; 1; 0; 0; 0 | — |
| SECONDARY Short Form Health Survey (SF-36) Score at Baseline |
49.27; 29.47 | — |
| SECONDARY Short-Form Health Survey (SF-36) Score at Follow-up Visit at 3 Months. |
46.83; 30.04 | — |
| SECONDARY Short-Form Health Survey (SF-36) Score at Study Exit (6 Month Visit) |
48.33; 31.90 | — |
| SECONDARY 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 |
55.0; 73.34; 60.02; 80.0; 76.66; 70.0 | — |
| SECONDARY 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 |
70.0; 68.0; 63.34; 80.02; 73.34; 80.0 | — |
| SECONDARY 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 |
71.66; 58.66; 66.68; 75.0; 76.66; 76.68 | — |
| SECONDARY 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 |
39.98; 33.32; 6.66; 6.66; 20.0; 19.98 | — |
| SECONDARY 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 |
40.0; 26.64; 0; 13.32; 13.32; 19.98 | — |
| SECONDARY 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 |
40.0; 39.98; 0; 6.66; 23.66; 33.32 | — |
| SECONDARY Number of Participants With Indicated Adverse Events |
1; 1; 1; 1; 1; 1 | — |
| SECONDARY Number of Subjects With at Least One Serious Adverse Event |
— | — |
| SECONDARY Safety: Physical Examination Summaries for Each Subject |
1; 1; 2; 2; 2; 1 | — |
| SECONDARY Safety: Number of Participants With Indicated Vital Sign Summaries |
1; 1; 1; 1; 1 | — |
| SECONDARY Safety: Number of Participants With Indicated Changes to Pulmonary Function Tests (PFTs) Related to Treatment Emergent Adverse Events |
1; 1; 1; 1; 1; 1 | — |
| SECONDARY Safety: Laboratory Test Summaries for Each Subject |
2; 1; 1; 1; 2; 1 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02916745). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.