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

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

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood and tissue sample collection

PROCEDURE

Computed Tomography

Undergo CT

PROCEDURE

Endobronchial Ultrasound Bronchoscopy

Undergo EBUS

PROCEDURE

Interstitial Photodynamic Therapy

Undergo I-PDT

RADIATION

Palliative Radiation Therapy

Undergo palliative radiation therapy

OTHER

Physical Performance Testing

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

DRUG

Verteporfin

Given IV

DEVICE

Laser: ML7710-PDT

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

Sponsors & Collaborators

• Modulight, Inc.

  collaborator UNKNOWN

• National Cancer Institute (NCI)

  collaborator NIH

• Roswell Park Cancer Institute

  lead OTHER

Principal Investigators

• Nathaniel Ivanick · Roswell Park Cancer Institute

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-10-01

Primary Completion

2029-10-01

Completion

2029-10-01

FDA Drug

Yes

Countries

• United States

Study Locations