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

9 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase I trial studies the side effects and how well light dosimetry system works during photodynamic therapy with porfimer sodium in treating participants with malignant mesothelioma , non-small cell lung cancer or any other malignancy with pleural disease undergoing surgery. Light dosimetry measures the amount of laser light given during photodynamic therapy. Photodynamic therapy uses a drug, such as porfimer sodium, that becomes active when it is exposed to light. The activated drug may kill tumor cells. Using light dosimetry for intraoperative photodynamic therapy may help doctors estimate how much light is delivered during photodynamic therapy and decide if the treatment should be stopped or continued.

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.

Is photodynamic therapy with porfimer sodium safe for humans?

Photodynamic therapy with porfimer sodium is generally safe, but it can cause some side effects like skin sensitivity to light, which can last for several weeks, and esophageal strictures (narrowing of the esophagus) in some cases. These side effects are not usually severe, but they are important to consider. ^{1 2 3 4 5}

How is the treatment Porfimer Sodium unique for mesothelioma and lung cancer?

Porfimer Sodium is unique because it is a photosensitizing agent used in photodynamic therapy (PDT), which involves activating the drug with light to kill cancer cells. This treatment selectively targets tumor tissues and causes cell death by producing reactive oxygen species when exposed to specific light wavelengths, offering a different approach compared to traditional chemotherapy or radiation. ^{1 3 5 6 7}

What data supports the effectiveness of this treatment for mesothelioma and lung cancer?

Photodynamic therapy (PDT) has shown promise in treating lung cancer and mesothelioma. In a study with patients having malignant pleural mesothelioma, those with early-stage disease had a median survival of 21 months after receiving PDT, suggesting it may be more effective in earlier stages. Additionally, new photosensitizers have demonstrated high efficiency in killing mesothelioma cells in laboratory settings. ^{6 7 8 9 10}

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

Photodynamic therapy of human lung cancer xenografts in mice. [2019]

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

Intracavitary photodynamic therapy for malignant pleural mesothelioma. [2019]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Water-Soluble Truncated Fatty Acid-Porphyrin Conjugates Provide Photo-Sensitizer Activity for Photodynamic Therapy in Malignant Mesothelioma. [2022]

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

Experimental photodynamic therapy for malignant pleural mesothelioma with pegylated mTHPC. [2018]

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

Intraoperative photodynamic therapy of the chest cavity in malignant pleural mesothelioma bearing rats. [2012]

6. England pubmed.ncbi.nlm.nih.gov

The pharmacokinetics and safety of porfimer after repeated administration 30-45 days apart to patients undergoing photodynamic therapy. [2021]

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

Patient predictors of esophageal stricture development after photodynamic therapy. [2015]

8. Japan pubmed.ncbi.nlm.nih.gov

[Porfimer sodium (Photofrin-II)]. [2006]

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

Photodynamic therapy in dermatology with porfimer sodium and benzoporphyrin derivative: an update. [2018]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Lack of effect of sex and disease state on the pharmacokinetics of porfimer sodium. [2018]