Photodynamic Therapy for Airway Blockage Due to Cancer

Recruiting in Buffalo (>99 mi)

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

Trial Summary

What is the purpose of this trial?

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.

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.

Is photodynamic therapy (PDT) safe for treating airway blockages 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 obstruction. It has been used successfully in various conditions with a low side effect profile, especially when compared to other treatments like laser therapy. ^{1 2 3 4 5}

How is photodynamic therapy different from other treatments for airway blockage due to cancer?

Photodynamic therapy (PDT) is unique because it uses a special drug that makes cancer cells sensitive to light, which is then activated by a laser to destroy the cancer cells. Unlike other treatments like laser ablation or stenting, PDT can be used for both palliative care and potentially curative purposes, especially in early-stage cancers, with fewer complications. ^{5 6 7 8 9}

Research Team

Nathaniel Ivanick, MD

Principal Investigator

Roswell Park Cancer Institute

Eligibility Criteria

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

My cancer cannot be removed by surgery, is blocking my airways, and cannot be cured with radiation alone.

My doctor agrees I can have radiation therapy for my tumor.

Exclusion Criteria

Known hypersensitivity/allergy to porphyrin

Patients with known allergy to eggs

I am not cleared for advanced bronchoscopy under general anesthesia.

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Japan pubmed.ncbi.nlm.nih.gov

Photodynamic therapy as an adjunct to surgery or other treatments for squamous cell lung cancers. [2021]

2. Singapore pubmed.ncbi.nlm.nih.gov

Airway obstruction following bronchoscopic photodynamic therapy in early centrally located lung cancer requiring extracorporeal membrane oxygenation. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

MR imaging-guided interstitial photodynamic laser therapy for advanced head and neck tumors. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Photodynamic therapy: a case series demonstrating its role in patients receiving mechanical ventilation. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

First-In-Human Computer-Optimized Endobronchial Ultrasound-Guided Interstitial Photodynamic Therapy for Patients With Extrabronchial or Endobronchial Obstructing Malignancies. [2022]

6. Japan pubmed.ncbi.nlm.nih.gov

[Interventional bronchoscopy]. [2011]

7. United States pubmed.ncbi.nlm.nih.gov

Endobronchial photodynamic therapy for lung cancer. [2007]

8. United States pubmed.ncbi.nlm.nih.gov

The treatment of malignant endobronchial obstruction with laser ablation. [2017]

9. United States pubmed.ncbi.nlm.nih.gov

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