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Photodynamic Therapy

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

Phase 2
Recruiting
Led By Keith Cengel, MD, PhD
Research Sponsored by Abramson Cancer Center at Penn Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status of 0-1.
Subjects treated with pemetrexed previously will be eligible only if 30 days have elapsed between the last dose of pemetrexed and the date of surgery.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights

MPM-PDT Trial Summary

This trial is testing whether adding a light-based therapy to surgery and chemo can improve survival in people with a certain type of lung cancer.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects include those related to Photofrin such as sensitivity to light, which could lead to burns if exposed too soon after treatment. Surgery may cause typical risks like bleeding and infection, while chemotherapy can result in nausea, fatigue, hair loss, and increased risk of infections.

MPM-PDT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can carry out all my daily activities without help.
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It has been over 30 days since my last pemetrexed treatment.
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I am medically cleared for surgery, including heart health.
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I understand the risks and benefits of this study and can sign the consent form.
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I have a specific type of mesothelioma and can potentially have all visible tumor removed.
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It's been over 30 days since my last cancer treatment.
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My cancer is confined to one side of my chest.
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I am 18 years old or older.

MPM-PDT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Survival months
Secondary outcome measures
Local Control
Progression-free survival months
Receipt of Pembrolizumab

MPM-PDT Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Photodynamic Therapy
2014
Completed Phase 4
~460
Chemotherapy
2003
Completed Phase 4
~3050

Find a Location

Who is running the clinical trial?

Abramson Cancer Center at Penn MedicineLead Sponsor
387 Previous Clinical Trials
145,593 Total Patients Enrolled
5 Trials studying Mesothelioma
87 Patients Enrolled for Mesothelioma
Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
359 Previous Clinical Trials
104,993 Total Patients Enrolled
5 Trials studying Mesothelioma
87 Patients Enrolled for Mesothelioma
Keith Cengel, MD, PhDPrincipal InvestigatorAbramson Cancer Center at Penn Medicine
3 Previous Clinical Trials
9 Total Patients Enrolled

Media Library

Photodynamic Therapy (Photodynamic Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02153229 — Phase 2
Mesothelioma Research Study Groups: patients who undergo RP alone, patients who undergo RP plus photofrin-based PDT
Mesothelioma Clinical Trial 2023: Photodynamic Therapy Highlights & Side Effects. Trial Name: NCT02153229 — Phase 2
Photodynamic Therapy (Photodynamic Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02153229 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA officially validated Radical Pleurectomy as a treatment option?

"We appraised the safety of radical pleurectomy to be 2, owing to its Phase 2 status with limited data attesting to efficacy but some evidence of security."

Answered by AI

How many participants is this trial limited to?

"Affirmative. Evidence on clinicaltrials.gov reveals that this investigation is actively enrolling patients, with the first posting occuring on May 1st 2014 and a recent update being made July 25th 2022. 102 participants are desired between two distinct medical centres."

Answered by AI

Is it feasible for individuals to join this trial at present?

"Affirmative. Clinicaltrials.gov provides evidence that this medical experiment, first posted on May 1st 2014, is in need of participants to move forward with the trial. The study intends to recruit 102 individuals from 2 different locations."

Answered by AI

What former investigations have been conducted on Radical Pleurectomy?

"Currently, the landscape of Radical Pleurectomy clinical trials are in Phase 1 and 2. There is a concentration of studies running out of Philadelphia, Pennsylvania but 6 medical sites across the United States have active investigations into this procedure."

Answered by AI
~0 spots leftby May 2024