Ignite Creation Date:
2025-12-24 @ 2:11 PM
Ignite Modification Date:
2026-02-03 @ 9:41 PM
Study NCT ID:
NCT03735095
Status:
TERMINATED
Last Update Posted:
2025-04-16
First Post:
2018-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Endobronchial Ultrasound Guided Interstitial Photodynamic Therapy in Treating Patients With Locally Advanced Lung Cancer
Sponsor:
Roswell Park Cancer Institute
Organization:
Study Overview
Official Title:
Endobronchial Ultrasound Transbronchial Needle Guided Interstitial Photodynamic Therapy for Palliation of Locally Advanced Lung Cancer and Advanced Cancers Obstructing the Airway -Phase I/II
Status:
TERMINATED
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
was paused by device company for a long period of time
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This Phase I/Il studies the side effects of endobronchial ultrasound guided interstitial photodynamic therapy work in treating patients with lung cancer that has spread to nearby tissues or lymph nodes. Photodynamic therapy consists of injecting a light sensitive drug called a photosensitizer, such as porfimer sodium, into the vein, waiting for it to accumulate in the tumor, and then activating it with a red laser light. Giving photodynamic therapy with Porfimer sodium may reduce the tumor size in patients with lung cancer.
Detailed Description:
PRIMARY OBJECTIVES PHASE 1:
I. To evaluate the safety and potential efficacy of endobronchial ultrasound with transbronchial needle (EBUS-TBN) guided interstitial photodynamic therapy (EBUS-TBN I-PDT) and/or I-PDT and/or photodynamic therapy (PDT) in patients with malignant airway obstructions using porfimer sodium as a photosensitizer.
PRIMARY OBJECTIVE Phase II
* I. To assess the tumor response to treatment.
* II To observe changes in well being
SECONDARY OBJECTIVES:
* I. To evaluate local progression-free survival (PFS).
* II.To compare the treatment planning in DOSIE™ with the plan generated in COMSOL™ - COHORT A ONLY
* III. To measure changes in tumor pO2, optical properties, and irradiance and fluence in relationship to response
EXPLORATORY OBJECTIVES:
I. Examine porfimer sodium retention in the target tumor tissue. II. Examine the relationship between immune biomarkers and response.
OUTLINE:
Patients receive Porfimer sodium intravenously (IV) over 20 minutes delivery of I-PDT. 20 minutes 48 hours +/- 4 hours before receiving I-PDT. I-PDT is then received over 1-2 hours.
After completion of study treatment, patients are followed up at 4, 8, 12, and 24 weeks.
I. To evaluate the safety and potential efficacy of endobronchial ultrasound with transbronchial needle (EBUS-TBN) guided interstitial photodynamic therapy (EBUS-TBN I-PDT) and/or I-PDT and/or photodynamic therapy (PDT) in patients with malignant airway obstructions using porfimer sodium as a photosensitizer.
PRIMARY OBJECTIVE Phase II
* I. To assess the tumor response to treatment.
* II To observe changes in well being
SECONDARY OBJECTIVES:
* I. To evaluate local progression-free survival (PFS).
* II.To compare the treatment planning in DOSIE™ with the plan generated in COMSOL™ - COHORT A ONLY
* III. To measure changes in tumor pO2, optical properties, and irradiance and fluence in relationship to response
EXPLORATORY OBJECTIVES:
I. Examine porfimer sodium retention in the target tumor tissue. II. Examine the relationship between immune biomarkers and response.
OUTLINE:
Patients receive Porfimer sodium intravenously (IV) over 20 minutes delivery of I-PDT. 20 minutes 48 hours +/- 4 hours before receiving I-PDT. I-PDT is then received over 1-2 hours.
After completion of study treatment, patients are followed up at 4, 8, 12, and 24 weeks.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2018-01969 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| I 279415 | OTHER | Roswell Park Cancer Institute | View | |
| 1R44CA265656 | NIH | None | https://reporter.nih.gov/quic… | View |