Photodynamic Therapy for Mesothelioma and Lung Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Roswell Park Cancer Institute

Disqualifiers: Brain metastases, Low WBC, Low platelets, others

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

Compensation: Varies

Number of Visits: 31

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method of using light therapy to treat certain cancers, such as mesothelioma and non-small cell lung cancer, during surgery. The treatment uses porfimer sodium, a photosensitizing agent, which activates upon light exposure and may help kill cancer cells. Researchers aim to determine the optimal light dosage needed to maximize the therapy's effectiveness. Individuals with cancer affecting the lung lining who have not recently undergone chemotherapy or radiation may be suitable candidates for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot have had chemotherapy or radiotherapy within 4 weeks before joining the study.

What prior data suggests that this light dosimetry system is safe for photodynamic therapy?

Previous studies have shown that porfimer sodium has some known side effects. One important safety point is its potential to cause airway blockage and breathing problems, especially if tumors are in areas prone to swelling after treatment, which could make breathing difficult. It is used in photodynamic therapy (PDT), where the drug combines with light to target and kill cancer cells.

The FDA has already approved porfimer sodium for treating other cancers, such as esophageal cancer. This approval indicates that the drug's safety has been well-studied, but it does not eliminate risks for other conditions, like lung cancer.

As for treatment tolerance, this is a Phase 1 trial. Phase 1 trials primarily focus on safety, so there is limited information on overall patient reactions. The goal is to learn more about side effects and how the body processes the treatment. Participation in this trial helps researchers better understand these risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for mesothelioma and lung cancer, which often include surgery, chemotherapy, and radiation, porfimer sodium offers a unique approach by using a mechanism called photodynamic therapy (PDT). Researchers are excited because this involves administering porfimer sodium intravenously, which then targets cancer cells when activated by a specific type of light. This method can potentially minimize damage to surrounding healthy tissues and reduce side effects. Additionally, the precision of light activation makes it possible to directly target and treat tumors, offering hope for improved outcomes in a shorter timeframe compared to traditional therapies.

What evidence suggests that this light dosimetry system is effective for treating mesothelioma and lung cancer?

Research has shown that photodynamic therapy (PDT) with porfimer sodium effectively treats certain lung cancers. It clears blockages and relieves symptoms in people with non-small cell lung cancer (NSCLC). In this trial, participants will receive porfimer sodium, a drug that activates upon exposure to light, aiding in the destruction of cancer cells. Studies indicate that it can slow tumor recurrence, making it a promising cancer treatment. This method works well by targeting and destroying cancer cells when combined with light therapy. ^{5 6 7 8 9}

Who Is on the Research Team?

Saikrishna S. Yendamuri

Principal Investigator

Roswell Park Cancer Institute

Are You a Good Fit for This Trial?

This trial is for adults with malignant mesothelioma, non-small cell lung cancer, or pleural disease who are undergoing surgery. They must be in fair to good physical condition (ECOG 0-2), agree to use birth control if applicable, and not have distant spread of the disease. People with low white blood cells or platelets, liver issues, uncontrolled illnesses like heart failure or infections, brain metastases, recent other treatments or investigational drugs can't join.

Inclusion Criteria

Subjects 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 6 months after surgery.

I am able to get out of my bed or chair and move around.

The subject must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent prior to receiving any study related procedure.

Exclusion Criteria

I do not have brain metastases.

Your blood test shows that your creatinine level is higher than 2 mg/dL.

Your SGOT or SGPT levels are more than three times the normal limit.

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 and undergo intraoperative photodynamic therapy (IO-PDT) via a light dosimetry system

1 week

1 visit (in-person for surgery and PDT)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Follow-up at 30 days, within 4 weeks from surgery and PDT, and every 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Light Dosimetry
• Light Dosimetry for Intranoperative Therapy
• Porfimer Sodium

Trial Overview

The study tests a light dosimetry system during photodynamic therapy using porfimer sodium on patients having surgery for certain cancers affecting the chest lining. It aims to determine how well this method works by measuring laser light used to activate the drug that may kill tumor cells.

How Is the Trial Designed?

Group I: Treatment (porfimer sodium, IO-PDT) Experimental Treatment 3 Interventions

Participants receive porfimer sodium IV over 3-5 minutes and receive IO-PDT via a light dosimetry system 24-48 hours later.

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials

427

Recruited

40,500+

Lumeda,Inc.

Collaborator

Trials

1

Recruited

9+

Citations

1.

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.

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0022480421000330

Porfimer Sodium Versus PS785 for Photodynamic Therapy ...

Porfimer sodium and PS785 produced statistically similar delays of tumor regrowth after PDT when small tumors were treated at 24 and 48 h. At 72 h, PS785 ...

3.

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 ...

4.

cancer.gov

cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2018-01663

Light Dosimetry for Photodynamic Therapy with Porfimer ...

This phase I trial studies the side effects and how well light dosimetry system works during photodynamic therapy with porfimer sodium in treating patients ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10535460/

Recent Studies in Photodynamic Therapy for Cancer Treatment

Based on the study findings, an HPPH dose of 4 mg/m2 was found to be effective, and the light dose should not exceed 125 J/cm2 for optimal outcomes. The results ...

6.

mayoclinic.org

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

Porfimer (intravenous route) - Side effects & uses

This medicine may also treat changes in the esophagus that might lead to cancer, such as a condition called Barrett's esophagus. Porfimer ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03344861

Safety of PDT-Photofrin® Prior to Lung Surgery

Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during ...

8.

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 ...

9.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/label/2003/20451s012_photofrin_lbl.pdf

PHOTOFRIN® (porfimer sodium) for Injection

In these patients with late-stage obstructing lung cancer, median survival was 174 days in PDT-treated patients and. 161 days in Nd:YAG-treated patients. The ...