Finding studies
Finding studies
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Lead
Roswell Park Cancer Institute
With
PRIMARY OBJECTIVES PHASE 1: I. To evaluate the safety and potential efficacy of endobronchial ultrasound with transbronchial needle (EBUS-TBN) guided interstitial photodynamic therapy (EBUS-TBN I-PDT) and/or I-PDT and/or photodynamic therapy (PDT) in patients with malignant airway obstructions using porfimer sodium as a photosensitizer. PRIMARY OBJECTIVE Phase II * I. To assess the tumor response to treatment. * II To observe changes in well being SECONDARY OBJECTIVES: * I. To evaluate local progression-free survival (PFS). * II.To compare the treatment planning in DOSIE™ with the plan generated in COMSOL™ - COHORT A ONLY * III. To measure changes in tumor pO2, optical properties, and irradiance and fluence in relationship to response EXPLORATORY OBJECTIVES: I. Examine porfimer sodium retention in the target tumor tissue. II. Examine the relationship between immune biomarkers and response. OUTLINE: Patients receive Porfimer sodium intravenously (IV) over 20 minutes delivery of I-PDT. 20 minutes 48 hours +/- 4 hours before receiving I-PDT. I-PDT is then received over 1-2 hours. After completion of study treatment, patients are followed up at 4, 8, 12, and 24 weeks.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
