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

Last updated: November 19, 2025
Sponsor: Roswell Park Cancer Institute
Overall Status: Active - Recruiting

Phase

1/2

Condition

Bronchiectasis

Treatment

Questionnaire Administration

Laser: ML7710-PDT

Biospecimen Collection

Clinical Study ID

NCT06306638
I-3901323
NCI-2024-01239
I-3901323
R01CA283547
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age >= 18 years of age

  • Eligibility checklist before registration requires review of case by theinterventional pulmonologist/s and radiation oncologist/s to approve anatomicfeasibility of an airway intervention and palliative radiotherapy

  • Patients with pathologic diagnosis of inoperable solid malignancy involvingextrabronchial tumor growth that causes airway obstruction and not amenable tocurative radiotherapy. All patients will have tumors requiring bronchoscopicintervention with endobronchial ultrasound (EBUS) at the time of I-PDT

  • Participants have at least one measurable lesion which is also the target lesion forResponse Evaluation Criteria in Solid Tumors (RECIST) measurement

  • Patients amenable to receive standard of care palliative radiotherapy to the targettumor, as determined by the radiation oncologist/s

  • Amenable to high resolution chest CT (with or without contrast due tocontraindication) 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 interventionalpulmonologist/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 participatingexternal sites

  • Participants of child-bearing potential must agree to use adequate contraceptivemethods (e.g., hormonal or barrier method of birth control; abstinence) prior tostudy entry and for 3 months after receiving the study drug. Should a woman becomepregnant or suspect she is pregnant while she or her partner is participating inthis study, she should inform her treating physician immediately

  • Participant or legal representative must understand the investigational nature ofthis study and sign an Independent Ethics Committee/Institutional Review Boardapproved written informed consent form prior to receiving any study relatedprocedure

Exclusion

Exclusion Criteria:

  • Pregnant or nursing female participants

  • Co-existing ophthalmic disease likely to require slit-lamp examination within thenext 30 days following I-PDT treatment

  • Any condition which in the investigator's opinion deems the participant anunsuitable candidate to receive the I-PDT

  • CT imaging suggestive of target tumor invasion into a major blood vessel (typicallyproximal to segmental vessels)

  • Known hypersensitivity/allergy to porphyrin

  • Patients who are not cleared by the anesthesiologist to undergo an advancedbronchoscopy procedure under general anesthesia

  • Patients diagnosed with porphyria

  • Patients with known allergy to eggs

  • Patients unwilling or unable to follow protocol requirements

Study Design

Total Participants: 53
Treatment Group(s): 9
Primary Treatment: Questionnaire Administration
Phase: 1/2
Study Start date:
October 01, 2024
Estimated Completion Date:
October 01, 2029

Study Description

PRIMARY OBJECTIVES:

I. To test the safety of our image-based treatment planning for image-guided interstitial photodynamic therapy (I PDT) with endobronchial ultrasound (EBUS) following standard of care palliative radiotherapy (p-XRT). (Phase I)

-To assess the efficacy of our image-based treatment planning for image-guided I-PDT following standard of care p-XRT. (Phase II)

SECONDARY OBJECTIVES:

  • To assess objective tumor response. (Phase I)

  • To evaluate changes in quality of life. (Phase I and II)

  • To measure changes in functional lung capacity. (Phase I and II)

  • To measure the relationship between the measured objective tumor response (at 12 +/- 2 weeks post I-PDT) and changes in therapeutic laser light transmission within the target tumor, as a future dosimetric marker for response. (Phase I and II)

  • To assess treatment effects on the immune contexture. (Phase I and II)

  • To monitor progression free survival. (Phase I and II)

OUTLINE: This is a phase I study, followed by a phase II.

PHASE I: Patients are assigned to 1 of 2 cohorts.

COHORT 1: Patients receive visudyne intravenously (IV) over 10 minutes and then undergo I-PDT with EBUS 60-90 minutes after visudyne for up to 3 treatment sessions. Patients undergo blood and tissue sample collection on study. Patients also undergo computed tomography (CT) throughout the trial.

COHORT 2: Patients undergo SOC p-XRT over a single fraction. Patients receive visudyne IV over 10 minutes and then undergo I-PDT with EBUS 60-90 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.

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 60-90 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.

After completion of study treatment, patients are followed up at 30 days and 8, 12, and 24 weeks.

Connect with a study center

  • Roswell Park Cancer Institute

    Buffalo, New York 14263
    United States

    Site Not Available

  • Roswell Park Cancer Institute

    Buffalo 5110629, New York 5128638 14263
    United States

    Active - Recruiting

  • Abramson Cancer Center

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.