Using light therapy after radiation to treat blocked airways from cancer
A Phase I/II Study of Interstitial Photodynamic Therapy Following Palliative Radiotherapy for Patients With Inoperable Malignant Central Airway Obstruction
This study is testing if a light therapy treatment after radiation can help people with advanced cancer who have blocked airways breathe better and improve their quality of life.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Roswell Park Cancer Institute Academic / other |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 2 sites (Buffalo, New York and 1 other locations) |
| Trial ID | NCT06306638 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with inoperable solid malignancies causing airway obstruction who are amenable to palliative radiotherapy.
Not a fit: Patients with operable tumors or those not requiring bronchoscopic intervention may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve breathing and quality of life for patients with advanced cancer-related airway obstructions.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in using photodynamic therapy for cancer treatment, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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 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 diagnosed with porphyria * Patients with known allergy to eggs * Patients unwilling or unable to follow protocol requirements
Where this trial is running
Buffalo, New York and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.