Surgery + Photodynamic Therapy for Mesothelioma

(MPM-PDT Trial)

Not currently recruiting at 3 trial locations
SM
Overseen BySally McNulty, RN
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Abramson Cancer Center at Penn Medicine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether adding a special light treatment called photodynamic therapy (PDT) to surgery can benefit people with epithelioid mesothelioma, a cancer affecting the lung lining. Researchers aim to determine if this combination extends patient survival compared to surgery alone. Participants should have mesothelioma confined to one side of the chest and be eligible for surgery to remove as much of the tumor as possible. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that photodynamic therapy (PDT) is usually well-tolerated by patients with mesothelioma. In past studies, combining PDT with surgery showed potential in improving patient outcomes. Although specific reports of serious side effects are absent, ongoing studies continue to monitor safety.

For radical pleurectomy, studies indicate a low risk of death within 30 days after the procedure, typically around 2.2%, suggesting the procedure is relatively safe in the short term.

Both treatments are being tested together to determine if they can extend the lives of mesothelioma patients. Since this trial is in an early stage, information on long-term safety is limited. However, current evidence suggests that most patients can handle these treatments well.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about combining Photodynamic Therapy (PDT) with Radical Pleurectomy (RP) for treating mesothelioma because PDT adds a new layer of precision to the treatment. PDT uses a drug called Photofrin that gets activated by light to target and destroy cancer cells specifically, minimizing damage to healthy tissue. This approach is different from the standard treatments like chemotherapy and radiation, which can affect both cancerous and healthy cells. By integrating PDT with surgery, there's potential for improved outcomes and fewer side effects, making it a promising option for patients with this challenging condition.

What evidence suggests that this trial's treatments could be effective for mesothelioma?

This trial will compare the outcomes of patients undergoing Radical Pleurectomy (RP) alone with those undergoing RP plus photofrin-based Photodynamic Therapy (PDT). Research has shown that combining PDT with surgery may help treat malignant pleural mesothelioma (MPM), a type of cancer. One study found that patients who had both surgery and PDT lived for about 13 to 14 months on average, compared to 10 months for those who only had surgery. PDT uses a drug called Photofrin, which light activates to kill cancer cells. Studies have found that higher doses of Photofrin are more effective at destroying mesothelioma. This treatment appears most effective when the cancer hasn't spread beyond the lungs. Overall, adding PDT to surgery might help patients with this cancer live longer.12367

Who Is on the Research Team?

KC

Keith Cengel, MD, PhD

Principal Investigator

Abramson Cancer Center at Penn Medicine

Are You a Good Fit for This Trial?

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.
See 4 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.
See 8 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
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

Find a Clinic Near You

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+

Citations

Photodynamic Therapy for Lung Cancer and Malignant ...PDT for malignant pleural mesothelioma appears promising and may improve local control and potentially prolong survival in properly selected patients who are ...
Photodynamic therapy for human malignant mesothelioma ...All PDT regimens were successful in destroying malignant mesothelioma. Photofrin II at 5 mg/kg was superior to 2 mg/kg (P < 0.005), light delivered at 50 mW/cm2 ...
Mesothelioma Photodynamic Therapy: Overview & EligibilityAnother study in the Annals of Thoracic Surgery found patients receiving surgery and PDT had a median survival of 13 to 14 months versus 10 months for surgery ...
Photodynamic therapy and mesotheliomaPhotodynamic therapy is most effective in treating mesothelioma that has not spread from the lungs to other parts of the body. Because it only ...
A Novel Prospective Study Assessing the Combination of ...We present a novel prospective trial combining proton therapy (PT) and photodynamic therapy (PDT) and the largest-ever mesothelioma PT experience (n = 10).
Surgery and Photodynamic Therapy in Treating Patients ...Combining photodynamic therapy with surgery may be an effective treatment for malignant mesothelioma. PURPOSE: Phase II trial to study the effectiveness of ...
Current status of PDT in the United StatesThere are currently about 23 recruiting interventional clinical studies designed to evaluate the safety and efficacy of PDT in adult patients, in the USA.
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