protocolSection identificationModule nctId: NCT06306638, orgStudyIdInfo id: I-3901323, secondaryIdInfos id: NCI-2024-01239, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: I-3901323, type: OTHER, domain: Roswell Park Cancer Institute, briefTitle: Interstitial Photodynamic Therapy Following Palliative Radiotherapy in Treating Patients With Inoperable Malignant Central Airway Obstruction, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2029-04-01, completionDateStruct date: 2029-04-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Roswell Park Cancer Institute, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Malignant Solid Neoplasm, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 39, type: ESTIMATED, armsInterventionsModule interventions name: Biospecimen Collection, interventions name: Computed Tomography, interventions name: Endobronchial Ultrasound Bronchoscopy, interventions name: Interstitial Photodynamic Therapy, interventions name: Palliative Radiation Therapy, interventions name: Physical Performance Testing, interventions name: Questionnaire Administration, interventions name: Verteporfin, outcomesModule primaryOutcomes measure: Incidence of >= grade 3 adverse events (Phase I), primaryOutcomes measure: Overall tumor response (Phase II), secondaryOutcomes measure: Overall tumor response (Phase I), secondaryOutcomes measure: Quality of life (Phase I and II), secondaryOutcomes measure: Functional lung capacity (Phase I and II), secondaryOutcomes measure: Change in the therapeutic laser light transmission (Phase I and II), secondaryOutcomes measure: Association between immune markers and tumor response (Phase I and II), secondaryOutcomes measure: Progression free survival (Phase I and II), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Roswell Park Cancer Institute, city: Buffalo, state: New York, zip: 14263, country: United States, contacts name: Nathaniel Ivanick, role: CONTACT, phone: 716-845-5873, email: Nathaniel.Ivanick@RoswellPark.org, contacts name: Nathaniel Ivanick, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.88645, lon: -78.87837, hasResults: False