Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT06306638

Interstitial Photodynamic Therapy Following Palliative Radiotherapy in Treating Patients With Inoperable Malignant Central Airway Obstruction

Led by Roswell Park Cancer Institute · Updated on 2026-04-06

42

Participants Needed

2

Research Sites

260 weeks

Total Duration

On this page

Sponsors

R

Roswell Park Cancer Institute

Lead Sponsor

M

Modulight, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Interstitial Photodynamic Therapy Following Palliative Radiotherapy in Treating Patients With Inoperable Malignant Central Airway Obstruction

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Review and approval by interventional pulmonologist and radiation oncologist for airway intervention and radiotherapy feasibility
  • Diagnosis of inoperable solid tumor causing airway blockage, requiring bronchoscopic intervention with endobronchial ultrasound at I-PDT
  • At least one measurable tumor lesion for response evaluation
  • Suitable to receive standard palliative radiotherapy to target tumor
  • Able to undergo high resolution chest CT scan with 0.625-1.25 mm slice thickness
  • Tumor accessible and suitable for I-PDT as determined by pulmonologists
  • Eastern Cooperative Oncology Group performance status of 3 or less
  • Platelet count of at least 100,000 cells/mm³
  • International normalized ratio less than 1.5 and activated partial thromboplastin time less than 1.5 times the upper limit of normal
  • Participants capable of pregnancy must agree to use effective contraception before and for 3 months after study drug
  • Able to understand and sign informed consent form
Not Eligible

You will not qualify if you...

  • Pregnant or nursing women
  • Eye diseases requiring slit-lamp exam within 30 days after I-PDT
  • Any condition making I-PDT unsafe as judged by investigator
  • CT showing tumor invasion into major blood vessels near segmental vessels
  • Known allergy or sensitivity to porphyrin
  • Not cleared for advanced bronchoscopy under general anesthesia by anesthesiologist
  • Diagnosis of porphyria
  • Known allergy to eggs
  • Unable or unwilling to follow study protocol requirements

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Roswell Park Cancer Institute

Buffalo, New York, United States, 14263

Actively Recruiting

2

Abramson Cancer Center

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

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Research Team

A

ASKRPCI@RoswellPark.org

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

3

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