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Interstitial Photodynamic Therapy for Central Airway Obstruction

This study is testing a treatment for patients with inoperable cancer that is blocking their central airways, making it hard to breathe. The treatment involves interstitial photodynamic therapy (I-PDT), which uses a special light to activate a drug called Visudyne to destroy cancer cells, after you've had palliative radiation therapy. Researchers want to see how safe this combined treatment is and how well it shrinks tumors. You might be eligible if you are at least 18 years old and have a solid tumor blocking your airway that cannot be removed by surgery. The study aims to enroll 42 participants and will measure side effects within 30 days of I-PDT and how much the tumor shrinks after 12 weeks.

Study design
This is a Phase I/II study, meaning it first checks for safety and then for effectiveness. It plans to enroll 42 participants.
What's involved
You would undergo blood and tissue sample collection, CT scans, and endobronchial ultrasound bronchoscopy (EBUS). You would also receive Visudyne intravenously and undergo I-PDT for up to three sessions.
Compensation
Not stated in the trial record.
Follow-up
The study measures side effects within 30 days after I-PDT and tumor response at 12 weeks after I-PDT.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06306638

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Roswell Park Cancer Institute
~42 participants
Updated 2026-04-06 on ClinicalTrials.gov
What's tested:Biospecimen CollectionComputed TomographyEndobronchial Ultrasound BronchoscopyInterstitial Photodynamic TherapyPalliative Radiation TherapyPhysical Performance Testing

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of >= grade 3 adverse events (Phase I)
Measured over Within 30 days post interstitial photodynamic therapy (I-PDT)
+1 more outcome measured

Conditions

Malignant Solid Neoplasm

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Solid Neoplasm

NCT06306638

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Roswell Park Cancer Institute

    Buffalo, New Yorkstudy coordinator listed

    Recruiting

  • Abramson Cancer Center

    Philadelphia, Pennsylvaniano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Nathaniel Ivanick · PRINCIPAL_INVESTIGATOR · Roswell Park Cancer Institute

Who to contact

[email protected]
[email protected]
1-877-275-7724
Email the study team

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Eligibility criteria

Inclusion

Age \>= 18 years of age
Eligibility checklist before registration requires review of case by the interventional pulmonologist/s and radiation oncologist/s to approve anatomic feasibility of an airway intervention and palliative radiotherapy
Patients with pathologic diagnosis of inoperable solid malignancy involving extrabronchial tumor growth that causes airway obstruction and not amenable to curative radiotherapy. All patients will have tumors requiring bronchoscopic intervention with endobronchial ultrasound (EBUS) at the time of I-PDT
Participants have at least one measurable lesion which is also the target lesion for Response Evaluation Criteria in Solid Tumors (RECIST) measurement
Patients amenable to receive standard of care palliative radiotherapy to the target tumor, as determined by the radiation oncologist/s
Amenable to high resolution chest CT (with or without contrast due to contraindication) with 0.625-1.25 mm slice thickness and slice interval 0.5-1 mm
Tumor is accessible and amenable to I-PDT, as determined by the interventional pulmonologist/s
Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 3
Platelets ≥ 100,000 cells/mm\^3 (International System of Units \[SI\] units 100 x 10\^9/L)
International normalized ratio (INR) \< 1.5 and activated partial thromboplastin time (aPTT) \< 1.5 x ULN. PTT or aPTT per institutional standards for participating external sites
Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and for 3 months after receiving the study drug. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion

Pregnant or nursing female participants
Co-existing ophthalmic disease likely to require slit-lamp examination within the next 30 days following I-PDT treatment
Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive the I-PDT
CT imaging suggestive of target tumor invasion into a major blood vessel (typically proximal to segmental vessels)
Known hypersensitivity/allergy to porphyrin
Patients who are not cleared by the anesthesiologist to undergo an advanced bronchoscopy procedure under general anesthesia
Patients diagnosed with porphyria
Patients with known allergy to eggs
Patients unwilling or unable to follow protocol requirements

What this trial measures

  • Incidence of >= grade 3 adverse events (Phase I)Within 30 days post interstitial photodynamic therapy (I-PDT)

    Will will be associated with treatment related adverse events .grade 3 (with attribution of 'possible', 'probable' or 'definite'. Will be assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v 5.0).

  • Overall tumor response (Phase II)At 12 weeks post I-PDT

    Will be assessed by complete response (CR) or partial response (PR) defined by the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1) criteria.