Phase
Condition
Bronchiectasis
Treatment
Questionnaire Administration
Laser: ML7710-PDT
Biospecimen Collection
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age >= 18 years of age
Eligibility checklist before registration requires review of case by theinterventional pulmonologist/s and radiation oncologist/s to approve anatomicfeasibility of an airway intervention and palliative radiotherapy
Patients with pathologic diagnosis of inoperable solid malignancy involvingextrabronchial tumor growth that causes airway obstruction and not amenable tocurative radiotherapy. All patients will have tumors requiring bronchoscopicintervention with endobronchial ultrasound (EBUS) at the time of I-PDT
Participants have at least one measurable lesion which is also the target lesion forResponse Evaluation Criteria in Solid Tumors (RECIST) measurement
Patients amenable to receive standard of care palliative radiotherapy to the targettumor, as determined by the radiation oncologist/s
Amenable to high resolution chest CT (with or without contrast due tocontraindication) with 0.625-1.25 mm slice thickness and slice interval 0.5-1 mm
Tumor is accessible and amenable to I-PDT, as determined by the interventionalpulmonologist/s
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)
International normalized ratio (INR) < 1.5 and activated partial thromboplastin time (aPTT) < 1.5 x ULN. PTT or aPTT per institutional standards for participatingexternal sites
Participants of child-bearing potential must agree to use adequate contraceptivemethods (e.g., hormonal or barrier method of birth control; abstinence) prior tostudy entry and for 3 months after receiving the study drug. Should a woman becomepregnant or suspect she is pregnant while she or her partner is participating inthis study, she should inform her treating physician immediately
Participant or legal representative must understand the investigational nature ofthis study and sign an Independent Ethics Committee/Institutional Review Boardapproved written informed consent form prior to receiving any study relatedprocedure
Exclusion
Exclusion Criteria:
Pregnant or nursing female participants
Co-existing ophthalmic disease likely to require slit-lamp examination within thenext 30 days following I-PDT treatment
Any condition which in the investigator's opinion deems the participant anunsuitable candidate to receive the I-PDT
CT imaging suggestive of target tumor invasion into a major blood vessel (typicallyproximal to segmental vessels)
Known hypersensitivity/allergy to porphyrin
Patients who are not cleared by the anesthesiologist to undergo an advancedbronchoscopy procedure under general anesthesia
Patients diagnosed with porphyria
Patients with known allergy to eggs
Patients unwilling or unable to follow protocol requirements
Study Design
Study Description
Connect with a study center
Roswell Park Cancer Institute
Buffalo, New York 14263
United StatesSite Not Available
Roswell Park Cancer Institute
Buffalo 5110629, New York 5128638 14263
United StatesActive - Recruiting
Abramson Cancer Center
Philadelphia 4560349, Pennsylvania 6254927 19104
United StatesActive - Recruiting

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