Photodynamic Therapy for Airway Blockage Due to Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Nathaniel Ivanick, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Roswell Park Cancer Institute

Disqualifiers: Pregnancy, Ophthalmic disease, Porphyria, others

No Placebo Group

Approved in 4 Jurisdictions

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}

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

I am 18 years old or older.

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.

Exclusion Criteria

Known hypersensitivity/allergy to porphyrin

Patients with known allergy to eggs

I am not cleared for advanced bronchoscopy under general anesthesia.

Trial 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 (Procedure)

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Roswell Park Cancer Institute Buffalo, NY

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute Lead Sponsor

National Cancer Institute (NCI) Collaborator

Modulight, Inc. Collaborator

References

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

Photodynamic therapy as an adjunct to surgery or other treatments for squamous cell lung cancers. [2021] Photodynamic therapy (PDT) was performed on 14 cases of tracheobronchial malignancies with variable tumor stages as an adjunct to surgery. We retrospectively reviewed these PDT cases to evaluate safety and oncologic outcome.

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

Airway obstruction following bronchoscopic photodynamic therapy in early centrally located lung cancer requiring extracorporeal membrane oxygenation. [2016] Photodynamic therapy (PDT) is a treatment modality of early central located non-small-cell lung cancer, and in patients who are unsuitable for surgical intervention. Most complications of PDT reported in the literature are minor and can be easily handled. We report a case presenting with nearly fatal complication: airway obstruction following bronchoscopic photodynamic therapy for early endobronchial lung cancer, requiring extracorporeal membrane oxygenation. An 81-year-old man was admitted to thoracic surgery division due to an early centrally located lung cancer. Due to multiple comorbidity and high surgical risk we performed bronchoscopic PDT instead of aggressive lung resection for the patient. After the procedure, he developed severe airway obstruction by tumor debris and required temporary cardiopulmonary support with extracorporeal membrane oxygenation. The patient recovered smoothly after the episode and was free from tumor recurrence for >2 years without any neurological sequelae.

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

MR imaging-guided interstitial photodynamic laser therapy for advanced head and neck tumors. [2021] Photodynamic therapy (PDT) is a site-specific tumor treatment involving the administration of a photosensitizer activated by the local application of light. In interstitial PDT (IPDT), multiple laser fibers are inserted into the depth of the tumor. Image guidance is essential for accurate, safe, and uniform light delivery. We report a novel technique of IPDT for advanced head and neck tumors involving an open interventional MR system. Initial results are encouraging, with minimal procedural morbidity, successful palliation of symptoms, and prolongation of expected survival time.

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

Photodynamic therapy: a case series demonstrating its role in patients receiving mechanical ventilation. [2019] Photodynamic therapy (PDT) has long been used to treat cancers within the tracheobronchial tree. There have been many reports about the use of PDT for the treatment of carcinoma in situ and for obstructive endobronchial lesions. PDT has not been previously reported in patients receiving mechanical ventilation. PDT offers the advantages of a relatively short duration of treatment, a low side effect profile, and relatively low risk when compared to Nd-YAG laser in patients receiving mechanical ventilation. We report the first successful use of PDT to wean patients from mechanical ventilation.

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] Patients with inoperable extrabronchial or endobronchial tumors who are not candidates for curative radiotherapy have dire prognoses with no effective long-term treatment options. To reveal that our computer-optimized interstitial photodynamic therapy (I-PDT) is safe and potentially effective in the treatment of patients with inoperable extra or endobronchial malignancies inducing central airway obstructions.

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

[Interventional bronchoscopy]. [2011] Patients with malignant obstruction of the central airway have been treated by interventional bronchoscopy such as Nd-YAG laser and airway stenting. These palliative therapies contribute to improving and maintaining the QOL of the patients. Photodynamic therapy (PDT) is one of the bronchoscopic therapy for centrally located early stage squamous cell carcinoma of the lung. PDT uses photosensitizing agents that accumulate in malignant tissue and can be activated by a laser energy.

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

Endobronchial photodynamic therapy for lung cancer. [2007] Endobronchial photodynamic therapy (PDT) is a minimally invasive technique for the palliation of major airway obstruction from lung cancer, and for the treatment of endobronchial microinvasive lung cancer.

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

The treatment of malignant endobronchial obstruction with laser ablation. [2017] We compared a new endoscopic treatment for malignant endobronchial obstruction known as photodynamic therapy (PDT) with the more established therapy of neodymium: yttrium-aluminum garnet laser (Nd:YAG) therapy.

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

Photodynamic therapy for airway malignancies: the Ohio State University experience since 1998. [2019] Although treatment of cutaneous breast and lung cancers with photodynamic therapy (PDT) was initiated in the 1970s and 1980s, approval of its use in the United States for non-small cell lung cancer (NSCLC) came in 1998. That same year, the first PDT procedure for NSCLC was performed at The Ohio State University (OSU), and since then, approximately 1000 cases of airway malignancies have been treated with PDT there. Based on this extensive experience at OSU, PDT has emerged as an effective alternative for the palliative treatment of hemoptysis, obstructive metastatic disease to the lungs, and tracheal lesions, with a low rate of complications. Moving beyond its role for symptomatic relief, PDT also may prove to be useful in the curative setting as induction therapy in conjunction with other modalities, such as surgery and chemotherapy, and for early airway cancer. Further investigation into the indirect systemic effects and associated inflammatory reactions with PDT may make the term photoimmunotherapy a more accurate designation.