This phase I/II trial studies the side effects of endobronchial ultrasound guided interstitial photodynamic therapy and how well it works in treating patients with lung cancer that has spread to nearby tissues or lymph nodes (locally advanced) or cancer that has spread to the lungs (advanced) and is obstructing the airway. 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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03735095.
PRIMARY OBJECTIVES:
I. For patients with locally advanced lung cancer (LALC) and malignancies causing airway obstructions: To evaluate the safety and potential efficacy of endobronchial ultrasound bronchoscopy (EBUS)-transbronchial needle (TBN) guided interstitial photodynamic therapy (I-PDT) and/or I-PDT and/or photodynamic therapy (PDT), using porfimer sodium as a photosensitizer. (Phase I, Cohort 0 [data collection completed])
II. To assess the tumor response to treatment. (Phase II, Cohort A and Cohort B)
III. To observe changes in well-being. (Phase II, Cohort A and Cohort B)
SECONDARY OBJECTIVES:
I. To evaluate progression-free survival (PFS). (Cohort A and Cohort B)
II. To compare the treatment planning in DOSIE (trademark) with the plan generated in COMSOL (trademark) in Cohort A only. (Cohort A and Cohort B)
III. To measure changes in tumor partial pressure of oxygen (pO2), optical properties, and irradiance and fluence in relationship to response. (Cohort A and Cohort B)
EXPLORATORY OBJECTIVES:
I. Examine porfimer sodium retention in the target tumor tissue. (Cohort A and Cohort B)
II. Examine the relationship between immune biomarkers and response. (Cohort A and Cohort B)
OUTLINE:
Patients receive porfimer sodium intravenously (IV) over 3-5 minutes 48 hours prior to the delivery of I-PDT. Patients then undergo EBUS-TBN guided I-PDT and/or I-PDT and/or PDT. Patients also undergo computed tomography (CT) within 2 weeks prior to I-PDT and then as clinically indicated, and undergo collection of blood samples on day 0, day 7-10, and 4, 8, 12, and 24 weeks.
After completion of study treatment, patients are followed for 24 weeks.
Lead OrganizationRoswell Park Cancer Institute
Principal InvestigatorNathaniel Ivanick