Phase II Study of Radical Pleurectomy With or Without Light Therapy for Malignant Pleural Mesothelioma
Sponsor: Abramson Cancer Center at Penn Medicine
ClinicalTrials ID:NCT02153229
This clinical trial is testing whether adding a special light therapy during surgery can improve outcomes for patients with a type of lung cancer called epithelioid malignant pleural mesothelioma (MPM).
Patient Parameters
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Program Overview
The study aims to find out if using a light-based treatment called photodynamic therapy (PDT) during surgery can help patients with epithelioid malignant pleural mesothelioma (MPM) live longer. Patients will be randomly assigned to either receive the light therapy during their surgery or not. All patients will undergo surgery to remove as much of the tumor as possible. Those in the PDT group will receive a special drug before surgery that makes the cancer cells sensitive to light, and then the light therapy will be applied during the operation.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with epithelioid malignant pleural mesothelioma (MPM) and eligible for surgery to remove the tumor.
- Cancer must be limited to one side of the chest.
- Must have completed any previous surgery, gene therapy, or chemotherapy at least 30 days before joining the study.
- If previously treated with the drug pemetrexed, at least 30 days must have passed since the last dose.
- Must be in good general health with an ECOG performance status of 0 or 1.
- Must be medically cleared for surgery, including heart health.
- Must be 18 years or older.
- Must be able to understand and sign a consent form acknowledging the experimental nature of the treatment and its potential risks and benefits.
Exclusion Criteria
- Have other active cancers that need treatment, except for certain skin, bladder, cervical, or early-stage prostate cancers.
- Pregnant or breastfeeding.
- Have a history of HIV.
- Have low white blood cell or platelet counts.
- Have high levels of creatinine in the blood (2.5 mg/dL or more).
- Have severe liver disease or high liver function test results.
- Have a condition called porphyria or are sensitive to certain light-activated drugs.
- Have received pemetrexed within 30 days of surgery.
- Have had extensive radiation treatment in the past.
- Have cancer that has spread beyond the chest.
- Have received more than two doses of chemotherapy before surgery.
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