Phase
Condition
Carcinoma
Neuroblastoma
Non-small Cell Lung Cancer
Treatment
Porfimer Sodium
Ultrasound-Guided Transbronchial Needle-Delivered Interstitial Photodynamic Therapy
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
> 18 year olds
Eligibility checklist before registration requires review of case by study surgeonor interventional pulmonologists to approve anatomic feasibility of an airwayintervention
For patients in Cohort B only. Patients are amenable to receive a palliativeradiotherapy of 8 Gy x1 48±4 h prior to the I-PDT, as determined by the radiationoncologist
Patients with an established pathologic diagnosis of small cell and/or non-smallcell lung cancer or other malignancies causing airway obstruction > 25% requiringbronchoscopic intervention. Or inoperable malignancies not candidates for curativeradiotherapy within the airway.
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 contraceptivemethods (e.g., hormonal or barrier method of birth control; abstinence) prior tostudy entry. Should a woman become pregnant or suspect she is pregnant while she orher partner is participating in this study, she should inform her treating physicianimmediately.
Participant must understand the investigational nature of this study and sign anIndependent Ethics Committee/Institutional Review Board approved written informedconsent form prior to receiving any study related procedure.
Exclusion
Exclusion Criteria:
Participants who have had radiotherapy to the target tumor within 4 weeks prior tothe scheduled I-PDT and/or PDT.
Uncontrolled intercurrent illness including, but not limited to, ongoing or activeinfection, symptomatic congestive heart failure, unstable angina pectoris, cardiacarrhythmia, or psychiatric illness/social situations that would limit compliancewith study requirements.
Pregnant or nursing female participants.
Co-existing ophthalmic disease likely to require slit-lamp examination within 14days following I-PDT and/or PDT treatment.
Known hypersensitivity/allergy to porphyrin.
Patients who are not cleared by the anesthesiologist to undergo an advancedbronchoscopy procedure under general anesthesia.
Patients with target tumor invading into the lumen of the esophagus, confirmed byesophago-gastro-duodenoscopy (EGD) with endoscopic ultrasound
Patients diagnosed with porphyria.
Unwilling or unable to follow protocol requirements.
Any condition which in the Investigator's opinion deems the participant anunsuitable candidate to receive I-PDT or PDT.
Study Design
Study Description
Connect with a study center
Roswell Park Cancer Institute
Buffalo, New York 14263
United StatesSite Not Available
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