Trial Outcomes & Findings for Photodynamic Therapy Using HPPH in Treating Patients With Advanced Non-Small Cell Lung Cancer That Blocks the Air Passages (NCT NCT00528775)
NCT ID: NCT00528775
Last Updated: 2014-06-10
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
6 months
Results posted on
2014-06-10
Participant Flow
Participant milestones
| Measure |
HPPH
Patients will receive 4 mg/m2 HPPH (given light exposure precautions) and approximately 2 days later be treated endoscopically with 150J/cm of 665 +-5nm light.
HPPH: 4 mg/m2 IV
endoscopic procedure: Treatment with 150 joules from laser
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
HPPH
Patients will receive 4 mg/m2 HPPH (given light exposure precautions) and approximately 2 days later be treated endoscopically with 150J/cm of 665 +-5nm light.
HPPH: 4 mg/m2 IV
endoscopic procedure: Treatment with 150 joules from laser
|
|---|---|
|
Overall Study
Other not specified
|
1
|
Baseline Characteristics
Photodynamic Therapy Using HPPH in Treating Patients With Advanced Non-Small Cell Lung Cancer That Blocks the Air Passages
Baseline characteristics by cohort
| Measure |
HPPH
n=6 Participants
Patients will receive 4 mg/m2 HPPH (given light exposure precautions) and approximately 2 days later be treated endoscopically with 150J/cm of 665 +-5nm light.
HPPH: 4 mg/m2 IV
endoscopic procedure: Treatment with 150 joules from laser
|
|---|---|
|
Age, Continuous
|
64 years
STANDARD_DEVIATION 12.52 • n=99 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Due to the study's early termination and inadequate number of patients, no patients were analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 monthsPopulation: Due to the study's early termination and inadequate number of patients, no patients were analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 monthsPopulation: Due to the study's early termination and inadequate number of patients, no patients were analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 monthsPopulation: Due to the study's early termination and inadequate number of patients, no patients were analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 monthsPopulation: Due to the study's early termination and inadequate number of patients, no patients were analyzed.
Outcome measures
Outcome data not reported
Adverse Events
HPPH
Serious events: 5 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HPPH
n=6 participants at risk
Patients will receive 4 mg/m2 HPPH (given light exposure precautions) and approximately 2 days later be treated endoscopically with 150J/cm of 665 +-5nm light.
HPPH: 4 mg/m2 IV
endoscopic procedure: Treatment with 150 joules from laser
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
16.7%
1/6 • Number of events 1
|
|
Cardiac disorders
Supraventricular tachycardia
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Death
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
16.7%
1/6 • Number of events 1
|
|
Injury, poisoning and procedural complications
Intubation complication
|
16.7%
1/6 • Number of events 1
|
|
Nervous system disorders
Neuropathy
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
16.7%
1/6 • Number of events 1
|
|
Surgical and medical procedures
Hospitalisation
|
16.7%
1/6 • Number of events 1
|
|
Surgical and medical procedures
Tracheostomy
|
16.7%
1/6 • Number of events 1
|
|
Vascular disorders
Haemorrhage
|
16.7%
1/6 • Number of events 1
|
Other adverse events
| Measure |
HPPH
n=6 participants at risk
Patients will receive 4 mg/m2 HPPH (given light exposure precautions) and approximately 2 days later be treated endoscopically with 150J/cm of 665 +-5nm light.
HPPH: 4 mg/m2 IV
endoscopic procedure: Treatment with 150 joules from laser
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
16.7%
1/6 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukocytosis
|
16.7%
1/6 • Number of events 1
|
|
Blood and lymphatic system disorders
White blood cell disorder
|
16.7%
1/6 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Asthenia
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Pyrexia
|
16.7%
1/6 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
16.7%
1/6 • Number of events 1
|
|
Injury, poisoning and procedural complications
Sunburn
|
16.7%
1/6 • Number of events 1
|
|
Investigations
Haemoglobin
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
33.3%
2/6 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
16.7%
1/6 • Number of events 1
|
Additional Information
Senior Administrator, Compliance - Clinical Research Services
Roswell Park Cancer Institute
Phone: 716-845-2300
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place