Interstitial Photodynamic Therapy Following Palliative Radiotherapy in Treating Patients With Inoperable Malignant Central Airway Obstruction

NCT06306638 | Recruiting Phase 1 DMC FDA Drug

• 3 other identifiers: I-3901323NCI-2024-01239R01CA283547
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 2

Brief Summary

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 radiotherapy that can ablate (a localized, nonsurgical destruction) the tumor also has high risk to cause significant toxicity, including bleeding, abnormal connections or passageways between organs or vessels and abnormal scar tissue that can also produce airway obstruction. Photodynamic therapy (PDT) is another possible treatment that can provide local control of the tumor. PDT consists of injecting a light sensitive drug (photosensitizer, PS) into the vein, waiting for the PS to accumulate in the tumor, and then activating it with a red laser light. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Giving interstitial photodynamic therapy following palliative radiotherapy may improve tumor response and survival without the serious side effects that are associated with the typical high dose curative x-ray radiotherapy alone in patients with malignant central airway obstruction.

Conditions

Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (2)

• Incidence of >= grade 3 adverse events (Phase I)

  Will will be associated with treatment related adverse events .grade 3 (with attribution of 'possible', 'probable' or 'definite'. Will be assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v 5.0).

  Within 30 days post interstitial photodynamic therapy (I-PDT)

• Overall tumor response (Phase II)

  Will be assessed by complete response (CR) or partial response (PR) defined by the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1) criteria.

  At 12 weeks post I-PDT

Secondary Outcomes (6)

• Overall tumor response (Phase I)

  At 12 weeks post I-PDT

• Quality of life (Phase I and II)

  At study enrollment, immediately prior to p-XRT and I-PDT, and at 4 and 12 weeks

• Functional lung capacity (Phase I and II)

  At study entry (baseline), 30 days and 12 weeks

• Change in the therapeutic laser light transmission (Phase I and II)

  During the I-PDT

• Association between immune markers and tumor response (Phase I and II)

  Prior and 7-10 days after the I-PDT

Study Arms (3)

Phase I cohort 1 (I-PDT, EBUS)

EXPERIMENTAL

Patients receive visudyne IV over 10 minutes and then undergo I-PDT with EBUS 60-120 minutes after visudyne for up to 3 treatment sessions. Patients undergo blood and tissue sample collection on study. Patients also undergo CT throughout the trial.

Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Endobronchial Ultrasound Bronchoscopy; Procedure: Interstitial Photodynamic Therapy; Other: Physical Performance Testing; Other: Questionnaire Administration; Drug: Verteporfin

Phase I cohort 2 (I-PDT, EBUS, palliative radiation therapy)

EXPERIMENTAL

Patients undergo SOC p-XRT over a single fraction. Patients receive visudyne IV over 10 minutes and then undergo I-PDT with EBUS 60-120 minutes after visudyne for up to 2 treatment sessions at least 12 weeks apart. Patients undergo blood and tissue sample collection on study. Patients also undergo CT throughout the trial.

Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Endobronchial Ultrasound Bronchoscopy; Procedure: Interstitial Photodynamic Therapy; Radiation: Palliative Radiation Therapy; Other: Physical Performance Testing; Other: Questionnaire Administration; Drug: Verteporfin; Device: Laser: ML7710-PDT

Phase II (I-PDT, EBUS, palliative radiation therapy)

EXPERIMENTAL

Phase II: Patients undergo SOC p-XRT over a single fraction. Patients receive visudyne IV over 10 minutes and then undergo I-PDT with EBUS 60-120 minutes after visudyne for up to 2 treatment sessions at least 12 weeks apart. Patients undergo blood and tissue sample collection on study. Patients also undergo CT throughout the trial.

Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Endobronchial Ultrasound Bronchoscopy; Procedure: Interstitial Photodynamic Therapy; Radiation: Palliative Radiation Therapy; Other: Physical Performance Testing; Other: Questionnaire Administration; Device: Laser: ML7710-PDT

Interventions

Biospecimen Collection PROCEDURE

Undergo blood and tissue sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Phase I cohort 1 (I-PDT, EBUS); Phase I cohort 2 (I-PDT, EBUS, palliative radiation therapy); Phase II (I-PDT, EBUS, palliative radiation therapy)

Computed Tomography PROCEDURE

Undergo CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, CT, CT Scan, tomography

Phase I cohort 1 (I-PDT, EBUS); Phase I cohort 2 (I-PDT, EBUS, palliative radiation therapy); Phase II (I-PDT, EBUS, palliative radiation therapy)

Endobronchial Ultrasound Bronchoscopy PROCEDURE

Undergo EBUS

Also known as: EBUS, Endobronchial Ultrasound

Phase I cohort 1 (I-PDT, EBUS); Phase I cohort 2 (I-PDT, EBUS, palliative radiation therapy); Phase II (I-PDT, EBUS, palliative radiation therapy)

Interstitial Photodynamic Therapy PROCEDURE

Undergo I-PDT

Also known as: I-PDT, Interstitial Illumination Photodynamic Therapy

Phase I cohort 1 (I-PDT, EBUS); Phase I cohort 2 (I-PDT, EBUS, palliative radiation therapy); Phase II (I-PDT, EBUS, palliative radiation therapy)

Palliative Radiation Therapy RADIATION

Undergo palliative radiation therapy

Also known as: Palliative Radiotherapy

Phase I cohort 2 (I-PDT, EBUS, palliative radiation therapy); Phase II (I-PDT, EBUS, palliative radiation therapy)

Physical Performance Testing OTHER

Ancillary studies

Also known as: Physical Fitness Testing, Physical Function Testing

Phase I cohort 1 (I-PDT, EBUS); Phase I cohort 2 (I-PDT, EBUS, palliative radiation therapy); Phase II (I-PDT, EBUS, palliative radiation therapy)

Questionnaire Administration OTHER

Ancillary studies

Phase I cohort 1 (I-PDT, EBUS); Phase I cohort 2 (I-PDT, EBUS, palliative radiation therapy); Phase II (I-PDT, EBUS, palliative radiation therapy)

Verteporfin DRUG

Given IV

Also known as: Benzoporphyrin Derivative Monoacid Ring A, BPD-MA, Visudyne

Phase I cohort 1 (I-PDT, EBUS); Phase I cohort 2 (I-PDT, EBUS, palliative radiation therapy)

Laser: ML7710-PDT DEVICE

Delivering the therapeutic 689+/-3 nm laser light during I-PDT. Measuring light transmission.

Also known as: Fiber-coupled diode laser: ML7710-PDT

Phase I cohort 2 (I-PDT, EBUS, palliative radiation therapy); Phase II (I-PDT, EBUS, palliative radiation therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 or legal representative 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

You may not qualify 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
• Patients diagnosed with porphyria
• Patients with known allergy to eggs
• Patients unwilling or unable to follow protocol requirements

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• Modulight, Inc.: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

RECRUITING

Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Interventions

Specimen Handling; Exercise Test; Verteporfin

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Porphyrins; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Nathaniel Ivanick

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ASKRPCI@RoswellPark.org

CONTACT

1-877-275-7724; askrpci@roswellpark.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 12, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2029
• Last Updated: November 25, 2025

Record last verified: 2025-11

Locations

US (2)