Lung Cancer Clinical Trial
Endobronchial Ultrasound Guided Interstitial Photodynamic Therapy in Treating Patients With Locally Advanced Lung Cancer
Summary
This Phase I/Ila 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 locally advanced lung cancer (LALC) in the central airway, 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 DOSIEâ„¢ with the plan generated in COMSOLâ„¢
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 2-4 hours prior to the delivery of I-PDT. Patients then undergo EBUS-TBN guided I-PDT over 30-45 minutes.
After completion of study treatment, patients are followed up at 4, 8, 12, and 24 weeks.
Eligibility Criteria
Inclusion Criteria:
Eligibility checklist before registration requires review of case by study surgeon or interventional pulmonologists to approve anatomic feasibility of an airway intervention
Patients with a diagnosis of small cell and/or non-small cell lung cancer or other malignancy that metastasize to the lung causing airway obstruction > 25% requiring bronchoscopic intervention
Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 3
Platelets >= 100,000 cells/mm^3 (International System of Units [SI] units 100 x 10^9/L).
Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure.
Exclusion Criteria:
Participants who have had radiotherapy to the target tumor within 4 weeks prior to the scheduled I-PDT and/or PDT.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Pregnant or nursing female participants.
Co-existing ophthalmic disease likely to require slit-lamp examination within 14 days following I-PDT and/or PDT treatment.
Known hypersensitivity/allergy to porphyrin.
Patients who are not cleared by the anesthesiologist to undergo an advanced bronchoscopy procedure under general anesthesia.
Patients diagnosed with porphyria.
Unwilling or unable to follow protocol requirements.
Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study drug.
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There is 1 Location for this study
Buffalo New York, 14263, United States More Info
Principal Investigator
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