Using light therapy after radiation to treat blocked airways from cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase I/II trial investigates the safety and efficacy of interstitial photodynamic therapy (I-PDT) following palliative radiotherapy in patients with inoperable malignant central airway obstruction. The study involves two cohorts: one receiving I-PDT after intravenous administration of visudyne, and the other receiving standard palliative radiotherapy before I-PDT. The trial aims to assess tumor response, quality of life, lung function, and immune response, with imaging and biospecimen collection throughout the process. The ultimate goal is to improve treatment outcomes for patients suffering from advanced-stage cancers that obstruct breathing passages.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 computed tomography (CT) scan (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 Criteria:

* 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 who have received 120 Gy total radiation dose delivered to a structure within 1 cm margin of tumor volume to be targeted by p-XRT and I-PDT
* Patients diagnosed with porphyria
* Patients with known allergy to eggs
* Patients unwilling or unable to follow protocol requirements

Where it's running

• Roswell Park Cancer Institute
  Buffalo, New York, United States Recruiting
• Abramson Cancer Center
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Nathaniel Ivanick — Roswell Park Cancer Institute
• Study coordinator: ASKRPCI@RoswellPark.org
• Email: askrpci@roswellpark.org
• Phone: 1-877-275-7724

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.