Phase 1
N=10
Safety of PDT-Photofrin® Prior to Lung Surgery
Lung Cancer · Lung Cancer Metastatic
Bottom Line
View on ClinicalTrials.gov: NCT03344861 ↗Enrolled (actual)
10
Serious AEs
40.0%
Results posted
Jan 2020
Primary outcome: Primary: Safety: Number of Participants With at Least One Adverse Event — 10 Participants — p=<0.05
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
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety: Number of Participants With at Least One Adverse Event |
10 | <0.05 sig |
| PRIMARY Safety: Physical Examination Summaries of Non-normal Findings for Each Subject |
1; 3; 1 | — |
| PRIMARY Safety: Vital Sign Summary of Abnormal Findings for Each Subject |
— | — |
| PRIMARY Safety: Laboratory Tests Summaries of Abnormal Findings for Each Subject |
1; 9 | — |
| PRIMARY Safety: Skin Photosensitivity Events Summaries of Abnormal Findings for Each Subject |
4 | <0.05 sig |
| SECONDARY Macroscopic Tissue Examination |
2.177 | — |
| SECONDARY Summary of Microscopic Tissue Examination: Percentage of Participants With Complete Response After Surgery |
20 | — |
| SECONDARY Microscopic Tissue Examination: Percent Tumor Cell Necrosis in Tumor Area After Surgery |
22.0 | — |
| SECONDARY Microscopic Tissue Examination: Brisk Inflammatory Reaction After Surgery |
9 | — |
| SECONDARY Microscopic Tissue Examination: Number of Participants With Cavitation in Normal Lung Area After Surgery |
1 | — |
| SECONDARY Microscopic Tissue Examination: Number of Participants With Hemorrhage Seen After Surgery |
6 | — |
| SECONDARY Microscopic Tissue Examination: Number of Participants With Pneumonitis in the Normal Lung After Surgery |
2 | — |
| SECONDARY Microscopic Tissue Examination: Number of Participants With Increased Alveolar Macrophages in the Normal Lung After Surgery |
10 | — |
| SECONDARY Microscopic Tissue Examination: Number of Participants With Atypical/Reactive Type 2 Pneumocytes in the Normal Lung After Surgery |
10 | — |
| SECONDARY Microscopic Tissue Examination: Number of Participants With Mucus Plugging/Mucositis in the Normal Lung After Surgery |
— | — |
| SECONDARY Microscopic Tissue Examination: Number of Participants With Interstitial Fibrosis in the Normal Lung After Surgery |
0; 1; 0; 9 | — |
| SECONDARY Microscopic Tissue Examination: Number of Participants With Necrosis in the Normal Lung After Surgery |
3 | — |
| SECONDARY Microscopic Tissue Examination: Number of Participants With Large Vessel Damage Indicated by Fibrinoid Necrosis, Thrombus, Vasculitis in the Normal Lung After Surgery |
1 | — |
| SECONDARY Microscopic Tissue Examination: Number of Participants With Acute Alveolar Damage in the Normal Lung After Surgery |
— | — |
| SECONDARY Microscopic Tissue Examination: Number of Participants With Organizing Pneumonia Pattern in the Normal Lung After Surgery |
7 | — |
| SECONDARY ECOG (Eastern Cooperative Oncology Group) Performance Status: Baseline |
7; 3 | — |
| SECONDARY ECOG Performance Status: Period 1 PDT Day 3 |
6; 4 | — |
| SECONDARY ECOG Performance Status: Period II Surgery (Day 13-18) |
7; 3 | — |
| SECONDARY ECOG Performance Status: Period III Follow-up (Day 20-25) |
0; 9; 1 | — |
| SECONDARY ECOG Performance Status: Period III Follow-up (Day 43 -48) |
7; 3 | — |
| SECONDARY ECOG Performance Status: Period III Follow-up (Day 103 - 108) |
9; 1 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03344861). 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.