Photodynamic Therapy for Lung Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Roswell Park Cancer Institute

Disqualifiers: Pregnancy, Porphyria, Cardiac arrhythmia, others

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

Compensation: Varies

Number of Visits: 4

Duration: 1-2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to treat lung cancer using photodynamic therapy. This approach involves injecting Porfimer Sodium, a drug that makes cancer cells sensitive to light, followed by laser application to shrink the tumor. The trial aims to assess the treatment's effectiveness and potential side effects for lung cancer that has spread nearby. Individuals with lung cancer causing an airway blockage of more than 25% who require bronchoscopic intervention may be suitable candidates for this trial. As a Phase 1, Phase 2 trial, the research focuses on understanding the treatment's effects in people and measuring its effectiveness in an initial, smaller group.

Do I need to stop my current medications for the trial?

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

What prior data suggests that this photodynamic therapy is safe for treating lung cancer?

Research has shown that photodynamic therapy with porfimer sodium has been safely used for some time. Porfimer sodium activates when exposed to a special light, aiding in tumor reduction. It is approved for treating lung cancer to clear blocked airways and relieve symptoms.

Studies have identified some side effects of this treatment, with common ones including swelling and mild pain in the treated area. Patients should be aware that if the tumor is in a challenging location, swelling may risk airway blockage.

Research on ultrasound-guided interstitial photodynamic therapy (using sound waves to guide treatment) also indicates safety. This method has been tested in individuals with lung cancer and has shown promise without major safety concerns.

Overall, both treatments are generally well-tolerated, but they come with some risks to consider. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about this treatment for lung cancer because it combines photodynamic therapy (PDT) with a unique delivery method. Unlike standard treatments like surgery, chemotherapy, or radiation, this approach uses porfimer sodium, a photosensitizing agent, activated by light delivered directly to the tumor via ultrasound-guided transbronchial needle. This targeted method means the treatment can potentially be more precise, minimizing damage to surrounding healthy tissue. Additionally, it could offer a new option for patients who may not be candidates for traditional therapies, providing hope for more effective and personalized cancer care.

What evidence suggests that this photodynamic therapy is effective for lung cancer?

Research has shown that photodynamic therapy using porfimer sodium effectively treats lung cancer. In this trial, participants will receive porfimer sodium followed by endobronchial ultrasound-guided interstitial photodynamic therapy (I-PDT). Studies have found that all patients with non-small cell lung cancer (NSCLC) had a complete response to this treatment. This therapy involves injecting a light-sensitive drug and activating it with a laser to shrink tumors. The FDA has approved photodynamic therapy for treating lung cancer in the airways. Endobronchial ultrasound, which allows doctors to see inside the airways, guides the treatment accurately, potentially making it safer and more effective. This method may help control tumor bleeding and improve symptoms. ^{3 6 7 8 9}

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 adults with lung cancer that's spread to nearby areas, who can undergo bronchoscopy under anesthesia. They must have a certain level of platelets in their blood, be able to use birth control if needed, and not be pregnant. People with recent radiotherapy, allergies to porphyrin, unstable health conditions or those unable to follow the study plan cannot join.

Inclusion Criteria

A specialist has confirmed that my airway can be treated with a procedure.

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

I am willing to undergo a specific low-dose radiation treatment as advised by my radiation oncologist.

Exclusion Criteria

My cancer has spread into the esophagus, confirmed by a special camera test.

Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive I-PDT or PDT

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

Treatment

Participants receive Porfimer sodium intravenously followed by EBUS-TBN guided interstitial photodynamic therapy

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

Visits at 4, 8, 12, and 24 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Porfimer Sodium
• Ultrasound-Guided Transbronchial Needle-Delivered Interstitial Photodynamic Therapy

Trial Overview The trial tests a treatment called interstitial photodynamic therapy (I-PDT) using Porfimer sodium on patients with advanced lung cancer. It involves injecting this drug and activating it with laser light inside the airways to shrink tumors.

How Is the Trial Designed?

Group I: Treatment (porfimer sodium, EBUS, and photodynamic therapy) Experimental Treatment 2 Interventions

Treatment (porfimer sodium, EBUS, and photodynamic therapy) Patients receive 2 mg/kg porfimer sodium IV over 3-5 minutes 48 +/- 4 hours prior to the delivery of I-PDT. Patients then undergo EBUS-TBN guided I-PDT over few hours.

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials

427

Recruited

40,500+

Pinnacle Biologics Inc.

Industry Sponsor

Trials

8

Recruited

1,000+

Simphotek Inc.

Collaborator

Trials

1

Recruited

20+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5015713/

Photodynamic Therapy of Non–Small Cell Lung Cancer ... Moghissi and colleagues reported complete response in 100% of their patients treated with porfimer sodium PDT (50). Corti and colleagues, in 40 patients, used ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT00754910

Photodynamic Therapy Using Porfimer Sodium in Treating ... PURPOSE: This clinical trial is studying how well photodynamic therapy using porfimer sodium works in treating patients with non-small cell lung cancer and ...

3. photofrin.com photofrin.com/healthcare-professional-home/

PDT with PHOTOFRIN® (porfimer sodium) for Injection PHOTOFRIN is indicated for the reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial NSCLC.

4. journalofsurgicalresearch.com journalofsurgicalresearch.com/article/S0022-4804(21)00033-0/abstract

Porfimer Sodium Versus PS785 for Photodynamic Therapy (PDT ... Multiple newer photosensitizers are in development, including PS785. The effectiveness of PS785 was compared with porfimer sodium in the treatment of human lung ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4272687/

Photodynamic Therapy for Lung Cancer and Malignant ... In comparison to an approximately six week photosensitivity with porfimer sodium, skin photosensitivity with NPe6 disappeared within two weeks in 85% of ...

6. photofrin.com photofrin.com/important-safety-information/

Important Safety Information Airway Obstruction and Respiratory Distress: Administer with caution to patients with tumors in locations where treatment-induced inflammation can obstruct the ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2011/020451s020lbl.pdf

Photofrin injection label - accessdata.fda.gov PHOTOFRIN® is indicated for the palliation of patients with completely obstructing esophageal cancer, or of patients with partially obstructing esophageal ...

8. mayoclinic.org mayoclinic.org/drugs-supplements/porfimer-intravenous-route/description/drg-20065580

Porfimer (intravenous route) - Side effects & uses Porfimer injection is used together with a special laser light to treat cancer of the esophagus (the part of the digestive tract that carries food to the ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT03344861

Safety of PDT-Photofrin® Prior to Lung Surgery This research study is being conducted to assess the safety of PDT in subjects with peripherally located malignant tumors in lung parenchyma prior to surgical ...