Photodynamic Therapy for Mesothelioma and Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new method of using light therapy to treat certain cancers, such as mesothelioma and non-small cell lung cancer, during surgery. The treatment uses porfimer sodium, a photosensitizing agent, which activates upon light exposure and may help kill cancer cells. Researchers aim to determine the optimal light dosage needed to maximize the therapy's effectiveness. Individuals with cancer affecting the lung lining who have not recently undergone chemotherapy or radiation may be suitable candidates for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot have had chemotherapy or radiotherapy within 4 weeks before joining the study.
What prior data suggests that this light dosimetry system is safe for photodynamic therapy?
Previous studies have shown that porfimer sodium has some known side effects. One important safety point is its potential to cause airway blockage and breathing problems, especially if tumors are in areas prone to swelling after treatment, which could make breathing difficult. It is used in photodynamic therapy (PDT), where the drug combines with light to target and kill cancer cells.
The FDA has already approved porfimer sodium for treating other cancers, such as esophageal cancer. This approval indicates that the drug's safety has been well-studied, but it does not eliminate risks for other conditions, like lung cancer.
As for treatment tolerance, this is a Phase 1 trial. Phase 1 trials primarily focus on safety, so there is limited information on overall patient reactions. The goal is to learn more about side effects and how the body processes the treatment. Participation in this trial helps researchers better understand these risks.12345Why are researchers excited about this trial?
Unlike standard treatments for mesothelioma and lung cancer, which often include surgery, chemotherapy, and radiation, porfimer sodium offers a unique approach by using a mechanism called photodynamic therapy (PDT). Researchers are excited because this involves administering porfimer sodium intravenously, which then targets cancer cells when activated by a specific type of light. This method can potentially minimize damage to surrounding healthy tissues and reduce side effects. Additionally, the precision of light activation makes it possible to directly target and treat tumors, offering hope for improved outcomes in a shorter timeframe compared to traditional therapies.
What evidence suggests that this light dosimetry system is effective for treating mesothelioma and lung cancer?
Research has shown that photodynamic therapy (PDT) with porfimer sodium effectively treats certain lung cancers. It clears blockages and relieves symptoms in people with non-small cell lung cancer (NSCLC). In this trial, participants will receive porfimer sodium, a drug that activates upon exposure to light, aiding in the destruction of cancer cells. Studies indicate that it can slow tumor recurrence, making it a promising cancer treatment. This method works well by targeting and destroying cancer cells when combined with light therapy.56789
Who Is on the Research Team?
Saikrishna S. Yendamuri
Principal Investigator
Roswell Park Cancer Institute
Are You a Good Fit for This Trial?
This trial is for adults with malignant mesothelioma, non-small cell lung cancer, or pleural disease who are undergoing surgery. They must be in fair to good physical condition (ECOG 0-2), agree to use birth control if applicable, and not have distant spread of the disease. People with low white blood cells or platelets, liver issues, uncontrolled illnesses like heart failure or infections, brain metastases, recent other treatments or investigational drugs can't join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive porfimer sodium intravenously and undergo intraoperative photodynamic therapy (IO-PDT) via a light dosimetry system
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Light Dosimetry
- Light Dosimetry for Intranoperative Therapy
- Porfimer Sodium
Find a Clinic Near You
Who Is Running the Clinical Trial?
Roswell Park Cancer Institute
Lead Sponsor
Lumeda,Inc.
Collaborator