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| ID | Type | Description | Link |
|---|---|---|---|
| RPCI-I-98707 | Other Identifier | Roswell Park Cancer Institute |
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drug cannot be prepared commercially
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Photodynamic therapy uses a drug, such as HPPH, that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. This may be an effective treatment for advanced non-small cell lung cancer that blocks the air passages.
PURPOSE: This phase II trial is studying how well photodynamic therapy using HPPH works in treating patients with advanced non-small cell lung cancer that blocks the air passages.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive HPPH IV over 1 hour on day 1. On day 3, patients undergo photodynamic therapy (PDT) comprising laser light delivered by flexible, fiberoptic fibers passed through the biopsy channel of an endoscope. Patients undergo endoscopic debridement on day 5. If viable tumor is found outside of the initial treatment area, patients may receive another dose of laser light without additional HPPH.
Patients may undergo tumor biopsies periodically during study for optional biomarker/correlative studies. Tumor tissue samples are analyzed for STAT3 cross-links by western blotting; apoptosis and inflammation biomarkers by immunohistochemistry, TUNEL, and other immunological laboratory methods; and tumor concentrations of HPPH by fluorescence emission spectroscopy.
After completion of study treatment, patients are followed at 4-6 weeks and then periodically thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HPPH | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HPPH | Drug | 4 mg/m2 IV |
| |
| endoscopic procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Response | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Palliation of Symptoms as Assessed by the Pulmonary Symptom Scale | 2 months | |
| Photosensitizer (HPPH) Concentration in Tumor | 2 months | |
| STAT3 Cross-links as Assessed by Western Blotting |
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DISEASE CHARACTERISTICS:
Biopsy confirmed advanced obstructing endobronchial non-small cell lung cancer
Ineligible for or refused surgical resection
Local endobronchial recurrence after prior surgical resection, radiotherapy, or chemotherapy allowed
No evidence of tumor encasement of major pulmonary vessels on CT scan of the chest
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Todd L. Demmy, MD | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263-0001 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All treated and eligible patients
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Tumor Response | Due to the study's early termination and inadequate number of patients, no patients were analyzed. | Posted | 6 months |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
Due to the study's early termination and inadequate number of patients, no patients were analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Administrator, Compliance - Clinical Research Services | Roswell Park Cancer Institute | 716-845-2300 |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D000077192 | Adenocarcinoma of Lung |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C083998 | 2-(1-hexyloxyethyl)-2-devinyl pyropheophorbide-a |
| D004724 | Endoscopy |
| ID | Term |
|---|---|
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
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| Procedure |
Treatment with 150 joules from laser |
|
| 2 months |
| Inflammation and Apoptosis as Assessed by Immunohistochemistry | 2 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Secondary | Palliation of Symptoms as Assessed by the Pulmonary Symptom Scale | Due to the study's early termination and inadequate number of patients, no patients were analyzed. | Posted | 2 months |
|
|
| Secondary | Photosensitizer (HPPH) Concentration in Tumor | Due to the study's early termination and inadequate number of patients, no patients were analyzed. | Posted | 2 months |
|
|
| Secondary | STAT3 Cross-links as Assessed by Western Blotting | Due to the study's early termination and inadequate number of patients, no patients were analyzed. | Posted | 2 months |
|
|
| Secondary | Inflammation and Apoptosis as Assessed by Immunohistochemistry | Due to the study's early termination and inadequate number of patients, no patients were analyzed. | Posted | 2 months |
|
|
| 5 |
| 6 |
| 4 |
| 6 |
| Supraventricular tachycardia | Cardiac disorders | Systematic Assessment |
|
| Death | General disorders | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Intubation complication | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Neuropathy | Nervous system disorders | Systematic Assessment |
|
| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hospitalisation | Surgical and medical procedures | Systematic Assessment |
|
| Tracheostomy | Surgical and medical procedures | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | Systematic Assessment |
|
| White blood cell disorder | Blood and lymphatic system disorders | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
|
| Asthenia | General disorders | Systematic Assessment |
|
| Pyrexia | General disorders | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Sunburn | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Haemoglobin | Investigations | Systematic Assessment |
|
| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D013514 | Surgical Procedures, Operative |