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Malignant Solid NeoplasmPhase 1/2NCT06306638

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

A Phase 1/2 study testing Biospecimen Collection, Computed Tomography and Endobronchial Ultrasound Bronchoscopy in people with Malignant Solid Neoplasm, run by Roswell Park Cancer Institute at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malignant Solid Neoplasm
What is being tested?
Biospecimen Collection, Computed Tomography and Endobronchial Ultrasound Bronchoscopy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
2 sitesUnited States
Study dates
1 Oct 2024to 1 Oct 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 computed tomography (CT) scan (with or without contrast due to contraindication) with 0.625-1.25 mm slice thickness and slice interval 0.5-1 mm
Show all 12Show fewer
  • 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 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

Who cannot join

  • 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
Show all 10Show fewer
  • Patients who have received 120 Gy total radiation dose delivered to a structure within 1 cm margin of tumor volume to be targeted by p-XRT and I-PDT
  • Patients diagnosed with porphyria
  • Patients with known allergy to eggs
  • Patients unwilling or unable to follow protocol requirements

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

ASKRPCI@RoswellPark.org contact

1-877-275-7724

askrpci@roswellpark.org

United States2 sites, 2 recruiting

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

    Nathaniel Ivanick, 716-845-5873, Nathaniel.Ivanick@RoswellPark.org

    Nathaniel Ivanick

    Recruiting

  • Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104

    Recruiting

Other trials in United States

About this study

Official title: A Phase I/II Study of Interstitial Photodynamic Therapy Following Palliative Radiotherapy for Patients With Inoperable Malignant Central Airway Obstruction

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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.

Being tested
Biospecimen Collection, Computed Tomography, Endobronchial Ultrasound Bronchoscopy, Interstitial Photodynamic Therapy, Palliative Radiation Therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood and tissue sample collection

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT

  • Endobronchial Ultrasound BronchoscopyProcedure or surgery

    Also called EBUS, Endobronchial Ultrasound

    Undergo EBUS

  • Interstitial Photodynamic TherapyProcedure or surgery

    Also called I-PDT, Interstitial Illumination Photodynamic Therapy

    Undergo I-PDT

  • Palliative Radiation TherapyRadiation

    Also called Palliative Radiotherapy

    Undergo palliative radiation therapy

  • Physical Performance TestingOther

    Also called Physical Fitness Testing, Physical Function Testing

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

  • VerteporfinDrug

    Also called Benzoporphyrin Derivative Monoacid Ring A, BPD-MA, Visudyne

    Given IV

  • Laser: ML7710-PDTDevice

    Also called Fiber-coupled diode laser: ML7710-PDT

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

Study groups in NCT06306638
Study groupRoleWhat they receive
Phase I cohort 1 (I-PDT, EBUS)ExperimentalPatients 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.
Receives: 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)ExperimentalPatients 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.
Receives: 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)ExperimentalPhase 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.
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

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

  2. 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.

    Measured: At 12 weeks post I-PDT

Secondary outcomes (6)

  1. Overall tumor response (Phase I)

    Will be assessed by CR or PR defined by the RECIST v 1.1 criteria.

    Measured: At 12 weeks post I-PDT

  2. Quality of life (Phase I and II)

    Will be monitored using the Functional Assessment of Cancer Therapy-Lung. This 36 item self-reported quality of life questionnaire measures responses across six domains: physical well-being, social/family well-being, relationship with doctor, emotional well-being, functional well-being, and additional concerns. This scale was chosen because multiple studies support its validity and use in clinical trials of lung cancer.

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

  3. Functional lung capacity (Phase I and II)

    Will be measured with the six-minute walk test.

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

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

    Will be measured with our light dosimetry system.

    Measured: During the I-PDT

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

    will be measured with flow cytometry in fresh blood samples collected prior and 7-10 days after the I-PDT.

    Measured: Prior and 7-10 days after the I-PDT

  6. Progression free survival (Phase I and II)

    Will be summarized using standard Kaplan-Meier methods.

    Measured: Time from date of study treatment to the time of first observed disease progression (RECIST 1.1 criteria) at the treated tumor site or, death due to any cause, assessed up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2024
  2. Study start1 Oct 2024
  3. Primary completion1 Oct 2029 (estimated)
  4. Study completion1 Oct 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06306638
Sponsor's protocol ID
I-3901323
Other IDs
NCI-2024-01239, I-3901323, R01CA283547
Status last verified
Nov 2026
First submitted
27 Feb 2024
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Biospecimen Collection, Computed Tomography and Endobronchial Ultrasound Bronchoscopy in people with Malignant Solid Neoplasm, run by Roswell Park Cancer Institute at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact ASKRPCI@RoswellPark.org (1-877-275-7724, askrpci@roswellpark.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of >= grade 3 adverse events (Phase I) (time frame: Within 30 days post interstitial photodynamic therapy (I-PDT)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06306638.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.

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