Clinical Research Directory
Browse clinical research sites, groups, and studies.
Interstitial Photodynamic Therapy Following Palliative Radiotherapy in Treating Patients With Inoperable Malignant Central Airway Obstruction
Sponsor: Roswell Park Cancer Institute
Summary
This phase I/II trial studies the side effects of interstitial photodynamic therapy following palliative radiotherapy and how well it works in treating patients with inoperable malignant central airway obstruction. Patients who have advanced stage cancer tumors in the lung can often have the breathing passages to the lung partially or completely blocked. These tumors could be due to lung cancer or other cancers (e.g., renal, breast, kidney, etc.) that spread to the lung. This blockage puts the patient at a higher risk for respiratory failure, post-obstructive pneumonia, and prolonged hospitalizations. Treatment for these patients may include bronchoscopic intervention (such as mechanical removal, stenting, laser cauterization, or ballooning), radiation therapy with and without chemotherapy. While palliative x-ray radiotherapy may help in shrinking the tumor, high dose curative radiotherapy that can ablate (a localized, nonsurgical destruction) the tumor also has high risk to cause significant toxicity, including bleeding, abnormal connections or passageways between organs or vessels and abnormal scar tissue that can also produce airway obstruction. Photodynamic therapy (PDT) is another possible treatment that can provide local control of the tumor. PDT consists of injecting a light sensitive drug (photosensitizer, PS) into the vein, waiting for the PS to accumulate in the tumor, and then activating it with a red laser light. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Giving interstitial photodynamic therapy following palliative radiotherapy may improve tumor response and survival without the serious side effects that are associated with the typical high dose curative x-ray radiotherapy alone in patients with malignant central airway obstruction.
Official title: A Phase I/II Study of Interstitial Photodynamic Therapy Following Palliative Radiotherapy for Patients With Inoperable Malignant Central Airway Obstruction
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
42
Start Date
2024-10-01
Completion Date
2029-10-01
Last Updated
2026-04-06
Healthy Volunteers
No
Conditions
Interventions
Biospecimen Collection
Undergo blood and tissue sample collection
Computed Tomography
Undergo CT
Endobronchial Ultrasound Bronchoscopy
Undergo EBUS
Interstitial Photodynamic Therapy
Undergo I-PDT
Palliative Radiation Therapy
Undergo palliative radiation therapy
Physical Performance Testing
Ancillary studies
Questionnaire Administration
Ancillary studies
Verteporfin
Given IV
Laser: ML7710-PDT
Delivering the therapeutic 689+/-3 nm laser light during I-PDT. Measuring light transmission.
Locations (2)
Roswell Park Cancer Institute
Buffalo, New York, United States
Abramson Cancer Center
Philadelphia, Pennsylvania, United States