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New treatment option for Malignant Solid Neoplasm
Official title Interstitial Photodynamic Therapy Following Palliative Radiotherapy in Treating Patients With Inoperable Malignant Central Airway Obstruction
ClinicalTrials.gov ID: NCT06306638
What this study is testing
What is Verteporfin?
Verteporfin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for malignant solid neoplasm.
Also referred to as Benzoporphyrin Derivative Monoacid Ring A, BPD-MA.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age \>= 18 years of age
- Eligibility checklist before registration requires review of case by the treatment pulmonologist/s and radiation oncologist/s to approve anatomic...
- Patients with pathologic diagnosis of inoperable solid malignancy involving extrabronchial tumor growth that causes airway obstruction and not...
- 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
You likely can't join if
- 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
See the full eligibility criteria
- Age \>= 18 years of age
- Eligibility checklist before registration requires review of case by the treatment 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...
- 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 treatment 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Buffalo, New York, United States
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Buffalo, New York, United States; Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.