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This Phase I/Il studies the side effects of endobronchial ultrasound guided interstitial photodynamic therapy work in treating patients with lung cancer that has spread to nearby tissues or lymph nodes. Photodynamic therapy consists of injecting a light sensitive drug called a photosensitizer, such as porfimer sodium, into the vein, waiting for it to accumulate in the tumor, and then activating it with a red laser light. Giving photodynamic therapy with Porfimer sodium may reduce the tumor size in patients with lung cancer.
Full description
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
SECONDARY OBJECTIVES:
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.
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19 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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