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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
Given IV
Undergo EBUS-TBN guided I-PDT
Roswell Park Cancer Institute
Buffalo, New York, United States
Number of Participants With Adverse Events That Are >= Grade 4 According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.0
Number of Participants with Adverse Events That Are \>= Grade 4 According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.0
Time frame: Up to 4 weeks
Number of Participants With Tumor Response
Will be reported using frequencies
Time frame: up to 24 weeks
Progression-free Survival (PFS) Assessed Using Modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Criteria
Will be summarized using standard Kaplan-Meier methods, with median progression-free survival (PFS) estimated with 95% confidence intervals. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Time frame: From initiation of treatment to time of first observed diseased progression or death assessed up to 24 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.