nctId: NCT06306638 id: I-3901323 id: NCI-2024-01239 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) 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 overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2029-04-01 date: 2029-04-01 date: 2024-03-12 date: 2024-03-12 name: Roswell Park Cancer Institute class: OTHER 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. conditions: Malignant Solid Neoplasm studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 39 type: ESTIMATED name: Biospecimen Collection name: Computed Tomography name: Endobronchial Ultrasound Bronchoscopy name: Interstitial Photodynamic Therapy name: Palliative Radiation Therapy name: Physical Performance Testing name: Questionnaire Administration name: Verteporfin measure: Incidence of >= grade 3 adverse events (Phase I) measure: Overall tumor response (Phase II) measure: Overall tumor response (Phase I) measure: Quality of life (Phase I and II) measure: Functional lung capacity (Phase I and II) measure: Change in the therapeutic laser light transmission (Phase I and II) measure: Association between immune markers and tumor response (Phase I and II) measure: Progression free survival (Phase I and II) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Roswell Park Cancer Institute city: Buffalo state: New York zip: 14263 country: United States name: Nathaniel Ivanick role: CONTACT phone: 716-845-5873 email: Nathaniel.Ivanick@RoswellPark.org name: Nathaniel Ivanick role: PRINCIPAL_INVESTIGATOR lat: 42.88645 lon: -78.87837 hasResults: False