Surgery + Photodynamic Therapy for Mesothelioma
(MPM-PDT Trial)

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen byKeith Cengel, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Abramson Cancer Center at Penn Medicine

No Placebo Group

Prior Safety Data

Trial Summary

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.

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.

+5 more

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.

+8 more

Participant Groups

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.

2Treatment groups

Experimental Treatment

Group I: patients who undergo RP plus photofrin-based PDTExperimental Treatment4 Interventions

Group II: patients who undergo RP aloneExperimental Treatment2 Interventions