💬In plain words
What the trial is, and whether it could suit you
This phase I/II trial studies the side effects of interstitial photodynamic therapy following palliative radiotherapy and how well it works in treating patients with inoperable malignant central airway obstruction. Patients who have advanced stage cancer tumors in the lung can often have the breathing passages to the lung partially or completely blocked. These tumors could be due to lung cancer or other cancers (e.g., renal, breast, kidney, etc.) that spread to the lung. This blockage puts the patient at a higher risk for respiratory failure, post-obstructive pneumonia, and prolonged hospitalizations. Treatment for these patients may include bronchoscopic intervention (such as mechanical removal, stenting, laser cauterization, or ballooning), radiation therapy with and without chemotherapy. While palliative x-ray radiotherapy may help in shrinking the tumor, high dose curative radiothera
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* Age \>= 18 years of age
* Eligibility checklist before registration requires review of case by the interventional pulmonologist/s and radiation oncologist/s to approve anatomic feasibility of an airway intervention and palliative radiotherapy
* Patients with pathologic diagnosis of inoperable solid malignancy involving extrabronchial tumor growth that causes airway obstruction and not amenable to curative radiotherapy. All patients will have tumors requiring bronchoscopic intervention with endobronchial ultrasound (EBUS) at the time of I-PDT
* Participants have at least one measurable lesion which is also the target lesion for Response Evaluation Criteria in Solid Tumors (RECIST) measurement
* Patients amenable to receive standard of care palliative radiotherapy to the target tumor, as determined by the radiation oncologist/s
* Amenable to high resolution chest CT (with or without contrast due to contraindication) 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 interventional pulmonologist/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 participating external sites
* 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 and for 3 months after receiving the study drug. 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:
* Pregnant or nursing female participants
* Co-existing ophthalmic disease likely to require slit-lamp examination within the next 30 days following I-PDT treatment
* Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive the I-PDT
* CT imaging suggestive of target tumor invasion into a major blood vessel (typically proximal to segmental vessels)
* 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
* Patients with known allergy to eggs
* Patients unwilling or unable to follow protocol requirements
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