Surgery + Photodynamic Therapy for Mesothelioma

(MPM-PDT Trial)

Recruiting at 3 trial locations

Overseen By Sally McNulty, RN

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Abramson Cancer Center at Penn Medicine

Must not be taking: Pemetrexed

Disqualifiers: Active invasive cancers, HIV, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

52 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must wait at least 30 days after your last chemotherapy treatment before participating.

What data supports the effectiveness of the treatment Surgery + Photodynamic Therapy for Mesothelioma?

Research shows that combining surgery with photodynamic therapy (PDT) for mesothelioma can lead to encouraging survival results, with some patients experiencing prolonged remission and improved quality of life. Studies indicate that patients with early-stage disease who received this combination treatment had a median survival of up to 21 months, suggesting potential benefits of this approach. ^{1 2 3 4 5}

Is the combination of surgery and photodynamic therapy safe for treating mesothelioma?

The combination of surgery and photodynamic therapy (PDT) for mesothelioma has shown some safety concerns, including a serious complication called esophagopleural fistula (an abnormal connection between the esophagus and the pleural cavity) in some patients. Postoperative complications were noted in more than 50% of patients, with two deaths reported due to these complications. ^{2 4 5 6 7}

How is the treatment of surgery combined with photodynamic therapy unique for mesothelioma?

This treatment is unique because it combines surgery with photodynamic therapy (PDT), a light-based treatment that not only targets cancer cells but also stimulates the immune system to fight the tumor. This approach allows for less drastic surgery and has shown promising results in improving survival rates for patients with mesothelioma. ^{1 2 5 8 9}

What is the purpose of this trial?

A randomized Phase II trial to test whether the addition of intraoperative Photofrin-mediated photodynamic therapy to radical pleurectomy and post-operative chemo.improves OS in the treatment of patients with epithelioid MPM. Subjects assigned to the PDT arm will be given the photosensitizer prior to surgery . All subjects will receive maximal surgical debulking. Subjects in the PDT arm will receive intraoperative treatment using real-time, isotropic light dosimetry.

Research Team

Keith Cengel, MD, PhD

Principal Investigator

Abramson Cancer Center at Penn Medicine

Eligibility Criteria

This trial is for adults with epithelioid malignant pleural mesothelioma who can undergo complete tumor removal. They must have an ECOG performance status of 0-1, indicating they are fully active or restricted in physically strenuous activity but ambulatory and able to carry out work of a light nature. Prior treatments like surgery, gene therapy, or chemo are okay if it's been over 30 days since the last treatment.

Inclusion Criteria

I can carry out all my daily activities without help.

It has been over 30 days since my last pemetrexed treatment.

I am medically cleared for surgery, including heart health.

Exclusion Criteria

I do not have severe liver disease or very high liver test results.

I received my last dose of pemetrexed less than 30 days before my planned surgery.

I have no active cancer needing treatment, except for certain skin, bladder, cervical, or early prostate cancers.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Treatment

Participants undergo radical pleurectomy with or without intraoperative Photofrin-mediated photodynamic therapy, followed by post-operative chemotherapy

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 years

Treatment Details

Interventions

• Chemotherapy
• Photodynamic Therapy
• Radical Pleurectomy

Trial Overview The study is testing if adding Photofrin-mediated photodynamic therapy (PDT) during surgery improves survival compared to just surgery and post-op chemo. Participants will be randomly assigned to receive PDT or not before their radical pleurectomy—a surgical procedure to remove part of the lining of the lungs—and subsequent chemotherapy.

Participant Groups

Group I: patients who undergo RP plus photofrin-based PDT Experimental Treatment 4 Interventions

Group II: patients who undergo RP alone Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

Abramson Cancer Center of the University of Pennsylvania

Lead Sponsor

Trials

360

Recruited

108,000+

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Extended Pleurectomy-Decortication-Based Treatment for Advanced Stage Epithelial Mesothelioma Yielding a Median Survival of Nearly Three Years. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Radical pleurectomy and intraoperative photodynamic therapy for malignant pleural mesothelioma. [2021]

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

Intracavitary photodynamic therapy for malignant pleural mesothelioma. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Operation and intracavitary photodynamic therapy for malignant pleural mesothelioma: a phase II study. [2019]

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

Photodynamic therapy for malignant pleural mesothelioma. [2019]

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

Esophagopleural fistula: a complication of photodynamic therapy. [2005]

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

Photodynamic therapy as an innovative treatment for malignant pleural mesothelioma. [2009]

8. England pubmed.ncbi.nlm.nih.gov

Photodynamic therapy for malignant pleural mesothelioma: the future of treatment? [2011]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Photodynamic therapy enhanced by hyperbaric oxygenation in palliation of malignant pleural mesothelioma: clinical experience. [2014]