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

Part of paid clinical trials in Buffalo, New York.

Sponsor
Roswell Park Cancer Institute
Study ID
NCT06306638
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Malignant Solid Neoplasm

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood and tissue sample collection
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Endobronchial Ultrasound Bronchoscopy — PROCEDURE
    Undergo EBUS
  • Interstitial Photodynamic Therapy — PROCEDURE
    Undergo I-PDT
  • Palliative Radiation Therapy — RADIATION
    Undergo palliative radiation therapy
  • Physical Performance Testing — OTHER
    Ancillary studies
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Verteporfin — DRUG
    Given IV
  • Laser: ML7710-PDT — DEVICE
    Delivering the therapeutic 689+/-3 nm laser light during I-PDT. Measuring light transmission.

Study Details

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.

Key Dates

Start date
Oct 1, 2024
Status verified
Mar 2026
Primary completion
Oct 1, 2029
Completion
Oct 1, 2029

Study Design

Enrollment
42 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase I cohort 1 (I-PDT, EBUS)
    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.
  • Experimental: Phase I cohort 2 (I-PDT, EBUS, palliative radiation therapy)
    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.
  • Experimental: Phase II (I-PDT, EBUS, palliative radiation therapy)
    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.

Primary Outcome Measure

Incidence of >= grade 3 adverse events (Phase I) [ Time Frame: Within 30 days post interstitial photodynamic therapy (I-PDT) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Roswell Park Cancer InstituteBuffaloNew York14263
Nathaniel Ivanick
[email protected]
716-845-5873
Nathaniel Ivanick (PRINCIPAL_INVESTIGATOR)
Abramson Cancer CenterPhiladelphiaPennsylvania19104-

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By research site
Roswell Park Cancer Institute· Buffalo, NYAbramson Cancer Center· Philadelphia, PA

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