Photodynamic Therapy for Airway Blockage Due to Cancer

Recruiting at 1 trial location

Overseen By [e-mail]

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Roswell Park Cancer Institute

Disqualifiers: Pregnancy, Ophthalmic disease, Porphyria, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

53 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness and safety of photodynamic therapy (PDT) following palliative radiotherapy for patients with blocked airways due to advanced cancer. PDT involves injecting a light-sensitive drug into the bloodstream, which accumulates in the tumor, and then activating it with a laser to control tumor growth. The trial seeks participants with advanced cancer causing airway blockage that cannot be treated with surgery or standard high-dose radiotherapy. Participants should have tumors requiring a specific bronchoscopic procedure and be willing to receive palliative radiotherapy. As a Phase 1 and Phase 2 trial, this research focuses on understanding the treatment's effects in people and assessing its effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that interstitial photodynamic therapy is safe for treating airway blockage due to cancer?

Research has shown that photodynamic therapy (PDT) is generally safe for treating airway blockages caused by cancer. Most issues with PDT are minor and manageable. However, rare cases of serious airway problems have occurred.

Studies have found that using PDT after palliative radiotherapy may improve tumor response and survival rates without the serious side effects linked to high-dose radiotherapy. While some risks exist, the treatment is often well-tolerated and can be a safer option than more aggressive treatments.

In summary, PDT is a promising approach with fewer serious side effects, but awareness of the rare, more severe risks is important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about interstitial photodynamic therapy (I-PDT) for airway blockage due to cancer because it offers a novel approach compared to traditional treatments like surgery, chemotherapy, or external radiation. Unlike standard therapies, I-PDT combines a photosensitizing agent called visudyne with endobronchial ultrasound (EBUS) to precisely target and destroy cancer cells from within the body. This method allows for targeted treatment with minimal damage to surrounding healthy tissue, potentially reducing side effects and improving patient outcomes. Additionally, I-PDT offers flexibility in treatment sessions and can be combined with palliative radiation therapy for enhanced efficacy, giving it an edge over existing options.

What evidence suggests that interstitial photodynamic therapy could be effective for airway blockage due to cancer?

Research has shown that interstitial photodynamic therapy (I-PDT) could effectively treat airway blockages caused by cancer. In this trial, participants in different groups will receive I-PDT, with some also receiving palliative radiation therapy. One study found that patients who received I-PDT had a 70% chance of surviving for at least one year, with an average survival time of 19 months. Another study discovered that combining I-PDT with radiation therapy can enhance tumor response to treatment. Specifically, patients with lung cancer and airway blockages who received both I-PDT and radiation had similar survival rates to those without blockages. Overall, these findings suggest that I-PDT might manage airway blockages effectively without the serious side effects often seen with high-dose radiation alone. ^{1 2 4 6 7}

Who Is on the Research Team?

Nathaniel Ivanick, MD

Principal Investigator

Roswell Park Cancer Institute

Are You a Good Fit for This Trial?

This trial is for patients with advanced stage cancer causing blockage in the lung's breathing passages, which may be due to various cancers that have spread to the lungs. Candidates must not be eligible for surgery but can undergo palliative radiotherapy and photodynamic therapy.

Inclusion Criteria

Amenable to high resolution chest CT (with or without contrast due to known allergy) with 0.625-1.25 mm slice thickness and slice interval 0.5-1 mm

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

Exclusion Criteria

Known hypersensitivity/allergy to porphyrin

Patients with known allergy to eggs

I am not cleared for advanced bronchoscopy under general anesthesia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Palliative Radiotherapy

Patients undergo standard of care palliative radiotherapy over a single fraction

1 week

1 visit (in-person)

Interstitial Photodynamic Therapy (I-PDT)

Patients receive visudyne IV and undergo I-PDT with EBUS for up to 3 treatment sessions

12-24 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Interstitial Photodynamic Therapy

Trial Overview

The study is testing interstitial photodynamic therapy after palliative radiotherapy on patients with malignant central airway obstruction. It aims to see if this combination improves tumor response and survival while minimizing severe side effects compared to high dose x-ray radiotherapy alone.

How Is the Trial Designed?

Group I: Phase II (I-PDT, EBUS, palliative radiation therapy) Experimental Treatment 8 Interventions

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.

Group II: Phase I cohort 2 (I-PDT, EBUS, palliative radiation therapy) Experimental Treatment 9 Interventions

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.

Group III: Phase I cohort 1 (I-PDT, EBUS) Experimental Treatment 7 Interventions

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.

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials

427

Recruited

40,500+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Modulight, Inc.

Collaborator

Trials

1

Recruited

50+

Published Research Related to This Trial

In a study of 102 patients treated for malignant endobronchial obstruction, photodynamic therapy (PDT) and neodymium: yttrium-aluminum garnet laser (Nd:YAG) therapy showed similar morbidity and mortality rates, indicating comparable safety profiles.

PDT is suggested to be a better treatment option due to its technical ease and potential safety benefits, as it does not require general anesthesia, making it a less invasive alternative to Nd:YAG therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The treatment of malignant endobronchial obstruction with laser ablation. Taber, SW., Buschemeyer, WC., Fingar, VH., et al.[2017]

Interventional bronchoscopy techniques, including Nd-YAG laser and airway stenting, are effective palliative treatments for patients with malignant central airway obstructions, enhancing their quality of life.

Photodynamic therapy (PDT) is a promising bronchoscopic treatment for early-stage squamous cell lung carcinoma, utilizing photosensitizing agents that target malignant tissues and are activated by laser energy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Interventional bronchoscopy]. Miyazawa, T.[2011]

Photodynamic therapy (PDT) has been effectively used at The Ohio State University for treating non-small cell lung cancer (NSCLC) since its approval in 1998, with around 1000 cases treated, demonstrating its efficacy as a palliative option for symptoms like hemoptysis and obstructive lung disease.

PDT shows potential not only for symptom relief but also as a curative treatment when combined with surgery and chemotherapy, suggesting it may play a broader role in cancer therapy, possibly leading to the term 'photoimmunotherapy' due to its systemic effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photodynamic therapy for airway malignancies: the Ohio State University experience since 1998. Ross, P.[2019]

Photodynamic therapy (PDT) has been successfully used for the first time in patients on mechanical ventilation, demonstrating its potential as a treatment option in this challenging setting.

PDT offers advantages such as a shorter treatment duration, lower side effects, and reduced risks compared to traditional Nd-YAG laser therapy, making it a safer alternative for patients with obstructive endobronchial lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photodynamic therapy: a case series demonstrating its role in patients receiving mechanical ventilation. Shah, SK., Ost, D.[2019]

Interstitial photodynamic therapy (I-PDT) was found to be safe for treating patients with inoperable extrabronchial or endobronchial tumors, with three out of ten patients surviving for over 8 months after treatment.

The personalized light dose delivery achieved high precision, and I-PDT showed potential benefits in overall survival and immune response, indicated by an increase in specific immune cells in some patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-In-Human Computer-Optimized Endobronchial Ultrasound-Guided Interstitial Photodynamic Therapy for Patients With Extrabronchial or Endobronchial Obstructing Malignancies. Ivanick, NM., Oakley, ER., Kunadharaju, R., et al.[2022]

Photodynamic therapy (PDT) can be an effective treatment for early non-small-cell lung cancer in patients who cannot undergo surgery, but it carries a risk of serious complications, as demonstrated in a case where an 81-year-old man experienced nearly fatal airway obstruction after the procedure.

Despite the severe complication requiring extracorporeal membrane oxygenation, the patient ultimately recovered well and remained free from tumor recurrence for over 2 years, highlighting the potential for successful outcomes even in high-risk cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Airway obstruction following bronchoscopic photodynamic therapy in early centrally located lung cancer requiring extracorporeal membrane oxygenation. Chang, YC., Lee, JM., Ko, WJ., et al.[2016]

Photodynamic therapy (PDT) was safely used in 14 patients with tracheobronchial malignancies, showing a mean survival of 23.9 months post-treatment, indicating its potential as an effective adjunct to surgery.

Out of the cases reviewed, 8 patients achieved a complete response to PDT, demonstrating its efficacy in treating recurrent mucosal carcinoma and alleviating bronchial obstruction caused by cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photodynamic therapy as an adjunct to surgery or other treatments for squamous cell lung cancers. Jheon, S., Kim, T., Kim, JK.[2021]

Endobronchial photodynamic therapy (PDT) is an effective minimally invasive treatment for relieving airway obstruction caused by lung cancer and for treating early-stage lung cancer, based on a review of clinical trials.

Second-generation photosensitizers like HPPH show promise in PDT for lung cancer, as they appear to have fewer side effects, particularly less skin photosensitivity compared to the FDA-approved photosensitizer Photofrin.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endobronchial photodynamic therapy for lung cancer. Loewen, GM., Pandey, R., Bellnier, D., et al.[2007]

A novel interstitial photodynamic therapy (IPDT) technique using an open interventional MRI system shows promise for treating advanced head and neck tumors, allowing for precise light delivery to the tumor site.

Initial results indicate minimal side effects, effective symptom relief, and an extension of expected survival time for patients undergoing this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MR imaging-guided interstitial photodynamic laser therapy for advanced head and neck tumors. Jäger, HR., Taylor, MN., Theodossy, T., et al.[2021]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06306638

Interstitial Photodynamic Therapy Following Palliative ...

Giving interstitial photodynamic therapy following palliative radiotherapy may improve tumor response and survival without the serious side effects that are ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37174102/

Computational Optimization of Irradiance and Fluence for ...

In a recent clinical study, we demonstrated that interstitial photodynamic therapy (I-PDT) is a safe and potentially effective treatment for ...

3.

journal.chestnet.org

journal.chestnet.org/article/S0012-3692(24)03848-0/fulltext

MALIGNANT AIRWAY OBSTRUCTION AND ...

One study demonstrated a one-year post-PDT survival rate of 70% and a median survival time of 19 months, with a median progression-free survival of 6 months.

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6837945/

Outcomes of patients with advanced non-small cell lung ...

Our study suggests that patients with lung cancer and CAO treated with PDT and RT ± chemotherapy have similar death risk as patients without CAO treated with RT ...

5.

aacrjournals.org

aacrjournals.org/cancerres/article/83/7_Supplement/2423/723853/Abstract-2423-Image-guided-interstitial

Abstract 2423: Image-guided interstitial photodynamic therapy ...

Conclusions: Augmenting I-PDT with p-XRT improves the rate of tumor response. Murine studies show that p-XRT increases tumor blood oxygenation ...

6.

trialx.com

trialx.com/clinical-trials/listings/295154/interstitial-photodynamic-therapy-following-palliative-radiotherapy-in-treating-patients-with-inoperable-malignant-central-airway-obstruction/

Interstitial Photodynamic Therapy Following Palliative ...

Giving interstitial photodynamic therapy following palliative radiotherapy may improve tumor response and survival without the serious side ...

7.

withpower.com

withpower.com/trial/phase-2-airway-obstruction-3-2024-9cf6d

Photodynamic Therapy for Airway Blockage Due to Cancer

Photodynamic therapy (PDT) is generally considered safe with most complications being minor and manageable, although there are rare cases of severe airway ...