Trial Outcomes & Findings for Endobronchial Ultrasound Guided Interstitial Photodynamic Therapy in Treating Patients With Locally Advanced Lung Cancer (NCT NCT03735095)
NCT ID: NCT03735095
Last Updated: 2025-04-16
Results Overview
Number of Participants with Adverse Events That Are \>= Grade 4 According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.0
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
19 participants
Primary outcome timeframe
Up to 4 weeks
Results posted on
2025-04-16
Participant Flow
Participant milestones
| Measure |
Treatment (Porfimer Sodium, EBUS, and Photodynamic Therapy)
Patients received IV of 2 mg/kg porfimer sodium over 3-5 minutes and 48 hours +/- 4 prior the I-PDT. Patients then undergo EBUS-TBN guided I-PDT over a few hours.
Porfimer Sodium: Given IV Ultrasound-Guided Transbronchial Needle-Delivered Interstitial Photodynamic Therapy: Undergo EBUS-TBN guided I-PDT Interstitial Photodynamic Therapy: Undergo EBUS-TBN guided I-PDT
|
|---|---|
|
Overall Study
STARTED
|
19
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Endobronchial Ultrasound Guided Interstitial Photodynamic Therapy in Treating Patients With Locally Advanced Lung Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Porfimer Sodium, EBUS, and Photodynamic Therapy)
n=19 Participants
Patients received IV of 2 mg/kg porfimer sodium over 3-5 minutes and 48 hours +/- 4 prior the I-PDT. Patients then undergo EBUS-TBN guided I-PDT over a few hours.
Porfimer Sodium: Given IV Ultrasound-Guided Transbronchial Needle-Delivered Interstitial Photodynamic Therapy: Undergo EBUS-TBN guided I-PDT
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=113 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=113 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=113 Participants
|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 13.2 • n=113 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=113 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=113 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=113 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=113 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=113 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=113 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=113 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=113 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=113 Participants
|
PRIMARY outcome
Timeframe: Up to 4 weeksPopulation: All treated and eligible patients
Number of Participants with Adverse Events That Are \>= Grade 4 According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.0
Outcome measures
| Measure |
Treatment (Porfimer Sodium, EBUS, and Photodynamic Therapy)
n=19 Participants
Patients received IV of 2 mg/kg porfimer sodium over 3-5 minutes and 48 hours +/- 4 prior the I-PDT. Patients then undergo EBUS-TBN guided I-PDT over a few hours.
Porfimer Sodium: Given IV Ultrasound-Guided Transbronchial Needle-Delivered Interstitial Photodynamic Therapy: Undergo EBUS-TBN guided I-PDT
|
|---|---|
|
Number of Participants With Adverse Events That Are >= Grade 4 According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.0
|
6 Participants
|
PRIMARY outcome
Timeframe: up to 24 weeksPopulation: All treated and eligible patients
Will be reported using frequencies
Outcome measures
| Measure |
Treatment (Porfimer Sodium, EBUS, and Photodynamic Therapy)
n=19 Participants
Patients received IV of 2 mg/kg porfimer sodium over 3-5 minutes and 48 hours +/- 4 prior the I-PDT. Patients then undergo EBUS-TBN guided I-PDT over a few hours.
Porfimer Sodium: Given IV Ultrasound-Guided Transbronchial Needle-Delivered Interstitial Photodynamic Therapy: Undergo EBUS-TBN guided I-PDT
|
|---|---|
|
Number of Participants With Tumor Response
|
0 participants
|
SECONDARY outcome
Timeframe: From initiation of treatment to time of first observed diseased progression or death assessed up to 24 weeksPopulation: All treated and eligible patients
Will be summarized using standard Kaplan-Meier methods, with median progression-free survival (PFS) estimated with 95% confidence intervals. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
Treatment (Porfimer Sodium, EBUS, and Photodynamic Therapy)
n=19 Participants
Patients received IV of 2 mg/kg porfimer sodium over 3-5 minutes and 48 hours +/- 4 prior the I-PDT. Patients then undergo EBUS-TBN guided I-PDT over a few hours.
Porfimer Sodium: Given IV Ultrasound-Guided Transbronchial Needle-Delivered Interstitial Photodynamic Therapy: Undergo EBUS-TBN guided I-PDT
|
|---|---|
|
Progression-free Survival (PFS) Assessed Using Modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Criteria
|
2.6 months
Interval 0.9 to 5.9
|
Adverse Events
Treatment (Porfimer Sodium, EBUS, and Photodynamic Therapy)
Serious events: 12 serious events
Other events: 16 other events
Deaths: 17 deaths
Serious adverse events
| Measure |
Treatment (Porfimer Sodium, EBUS, and Photodynamic Therapy)
n=19 participants at risk
Patients received IV of 2 mg/kg porfimer sodium over 3-5 minutes and 48 hours +/- 4 prior the I-PDT. Patients then undergo EBUS-TBN guided I-PDT over a few hours.
Porfimer Sodium: Given IV Ultrasound-Guided Transbronchial Needle-Delivered Interstitial Photodynamic Therapy: Undergo EBUS-TBN guided I-PDT
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
5.3%
1/19 • Number of events 1 • Up to 4 months
|
|
Gastrointestinal disorders
Esophageal fistula
|
5.3%
1/19 • Number of events 1 • Up to 4 months
|
|
Infections and infestations
Lung infection
|
10.5%
2/19 • Number of events 3 • Up to 4 months
|
|
Investigations
Platelet count decreased
|
5.3%
1/19 • Number of events 1 • Up to 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
15.8%
3/19 • Number of events 3 • Up to 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.3%
1/19 • Number of events 1 • Up to 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
10.5%
2/19 • Number of events 3 • Up to 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
10.5%
2/19 • Number of events 4 • Up to 4 months
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
5.3%
1/19 • Number of events 1 • Up to 4 months
|
Other adverse events
| Measure |
Treatment (Porfimer Sodium, EBUS, and Photodynamic Therapy)
n=19 participants at risk
Patients received IV of 2 mg/kg porfimer sodium over 3-5 minutes and 48 hours +/- 4 prior the I-PDT. Patients then undergo EBUS-TBN guided I-PDT over a few hours.
Porfimer Sodium: Given IV Ultrasound-Guided Transbronchial Needle-Delivered Interstitial Photodynamic Therapy: Undergo EBUS-TBN guided I-PDT
|
|---|---|
|
Blood and lymphatic system disorders
Leukocytosis
|
5.3%
1/19 • Number of events 1 • Up to 4 months
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
15.8%
3/19 • Number of events 3 • Up to 4 months
|
|
Gastrointestinal disorders
Constipation
|
5.3%
1/19 • Number of events 2 • Up to 4 months
|
|
Gastrointestinal disorders
Diarrhea
|
5.3%
1/19 • Number of events 1 • Up to 4 months
|
|
Gastrointestinal disorders
Dysphagia
|
10.5%
2/19 • Number of events 2 • Up to 4 months
|
|
Gastrointestinal disorders
Esophageal fistula
|
5.3%
1/19 • Number of events 1 • Up to 4 months
|
|
Gastrointestinal disorders
Esophageal ulcer
|
5.3%
1/19 • Number of events 1 • Up to 4 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
5.3%
1/19 • Number of events 2 • Up to 4 months
|
|
Gastrointestinal disorders
Nausea
|
10.5%
2/19 • Number of events 2 • Up to 4 months
|
|
Gastrointestinal disorders
Oral pain
|
5.3%
1/19 • Number of events 1 • Up to 4 months
|
|
Gastrointestinal disorders
Stomach pain
|
5.3%
1/19 • Number of events 1 • Up to 4 months
|
|
Gastrointestinal disorders
Vomiting
|
10.5%
2/19 • Number of events 2 • Up to 4 months
|
|
General disorders
Edema limbs
|
21.1%
4/19 • Number of events 5 • Up to 4 months
|
|
General disorders
Facial pain
|
5.3%
1/19 • Number of events 1 • Up to 4 months
|
|
General disorders
Fatigue
|
26.3%
5/19 • Number of events 6 • Up to 4 months
|
|
General disorders
Fever
|
10.5%
2/19 • Number of events 2 • Up to 4 months
|
|
General disorders
Malaise
|
5.3%
1/19 • Number of events 1 • Up to 4 months
|
|
General disorders
Non-cardiac chest pain
|
21.1%
4/19 • Number of events 4 • Up to 4 months
|
|
General disorders
Pain
|
10.5%
2/19 • Number of events 2 • Up to 4 months
|
|
Infections and infestations
Lung infection
|
5.3%
1/19 • Number of events 1 • Up to 4 months
|
|
Infections and infestations
Sepsis
|
5.3%
1/19 • Number of events 1 • Up to 4 months
|
|
Infections and infestations
Urinary tract infection
|
5.3%
1/19 • Number of events 1 • Up to 4 months
|
|
Injury, poisoning and procedural complications
Fall
|
10.5%
2/19 • Number of events 2 • Up to 4 months
|
|
Investigations
Cardiac troponin T increased
|
5.3%
1/19 • Number of events 1 • Up to 4 months
|
|
Investigations
Investigations - Other, specify
|
5.3%
1/19 • Number of events 1 • Up to 4 months
|
|
Metabolism and nutrition disorders
Anorexia
|
5.3%
1/19 • Number of events 1 • Up to 4 months
|
|
Metabolism and nutrition disorders
Dehydration
|
5.3%
1/19 • Number of events 1 • Up to 4 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.3%
1/19 • Number of events 1 • Up to 4 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.3%
1/19 • Number of events 1 • Up to 4 months
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
5.3%
1/19 • Number of events 1 • Up to 4 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.3%
1/19 • Number of events 1 • Up to 4 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
10.5%
2/19 • Number of events 2 • Up to 4 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
5.3%
1/19 • Number of events 1 • Up to 4 months
|
|
Nervous system disorders
Dizziness
|
10.5%
2/19 • Number of events 2 • Up to 4 months
|
|
Nervous system disorders
Headache
|
5.3%
1/19 • Number of events 1 • Up to 4 months
|
|
Psychiatric disorders
Anxiety
|
10.5%
2/19 • Number of events 2 • Up to 4 months
|
|
Psychiatric disorders
Insomnia
|
5.3%
1/19 • Number of events 1 • Up to 4 months
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
5.3%
1/19 • Number of events 1 • Up to 4 months
|
|
Renal and urinary disorders
Acute kidney injury
|
5.3%
1/19 • Number of events 1 • Up to 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
5.3%
1/19 • Number of events 2 • Up to 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.8%
3/19 • Number of events 3 • Up to 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
47.4%
9/19 • Number of events 11 • Up to 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
5.3%
1/19 • Number of events 1 • Up to 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
15.8%
3/19 • Number of events 3 • Up to 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
10.5%
2/19 • Number of events 2 • Up to 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
10.5%
2/19 • Number of events 2 • Up to 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
15.8%
3/19 • Number of events 3 • Up to 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
5.3%
1/19 • Number of events 1 • Up to 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
15.8%
3/19 • Number of events 3 • Up to 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
5.3%
1/19 • Number of events 1 • Up to 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal stenosis
|
5.3%
1/19 • Number of events 1 • Up to 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
10.5%
2/19 • Number of events 2 • Up to 4 months
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
5.3%
1/19 • Number of events 2 • Up to 4 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.3%
1/19 • Number of events 1 • Up to 4 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
10.5%
2/19 • Number of events 2 • Up to 4 months
|
|
Vascular disorders
Hypotension
|
10.5%
2/19 • Number of events 3 • Up to 4 months
|
Additional Information
Senior Administrator, Compliance - Clinical Research Services
Roswell Park Comprehensive Cancer Center
Phone: 716-845-2300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place