Phase II Trial of Intraopertive Photodynamic Therapy
Type: Pleural Mesothelioma
Intraoperative photodynamic therapy has shown astounding potential to increase mesothelioma survival rates. This treatment was pioneered by Dr. Joseph Friedberg.
Photodynamic Therapy During Surgery
This trial is testing intraoperative photodynamic therapy (PDT) in conjunction with radical pleurectomy followed by adjuvant chemotherapy. The spotlight of this trial is on the use of photodynamic therapy for patients with malignant pleural mesothelioma (MPM).
What to Expect
- Photodynamic therapy (PDT) – This treatment uses a drug that is only activated when exposed to certain light, usually a laser. Once the light activates the drug, the mesothelioma cells that absorbed the drug are killed.
- Radical pleurectomy – This surgical procedure removes the lining of the lung and visible tumors without removing the lung. The tumor must be considered fully operable for a patient to participate.
- Adjuvant chemotherapy – The word “adjuvant” simply means that the drug is administered after the surgical process is completed. Patients in this study are treated with Alimta and cisplatin post-surgery, unless their oncologist suggests an alternative.
The purpose of this study is to build on a previous Phase I study, which had impressive results in advanced stage mesothelioma patients. The Phase II trial is accepting a larger sample of patients to affirm the results of the Phase I trial.
Get Help Enrolling in This Trial
Some reasons to participate in this study include:
- Patients in a previous study experienced survived up to three times longer than the average patient.
- Being in the hands of the most talented mesothelioma doctors in the country.
- Prolonging their life expectancy with a lung-sparing pleurectomy and chemotherapy.
Science Behind the Study
The nature of pleural mesothelioma makes it hard for the light used in PDT to reach the cancerous cells. Traditional PDT can only penetrate the surface of the skin, but intraoperative PDT can be applied directly to the cancerous region.
Patients in the study are given a light-sensitive drug called photofrin. This drug is absorbed by mesothelioma cells, making them vulnerable to the light applied during surgery.
This approach is similar to the use of intraoperative chemotherapy because the goal is to kill microscopic mesothelioma cells left behind after surgery.
Research from 2012 revealed that PDT used during surgery produced surprisingly good results. Most of the patients outlived their prognoses by a considerable margin, and their disease was less aggressive if it came back.
There are several hypotheses for why Phase I clinical trials were so successful, including:
- PDT may initiate an immune response in patients, making it harder for tumors to grow back.
- Using surgery that spares the lung may allow patients to withstand further treatment better.
- The light administered to the tumor region may destroy the tumor’s blood vessels, which are essential for delivering nutrients that allow mesothelioma tumors to survive.
This clinical trial is a randomized study, but every participant in this study gets some form of treatment. This means some patients will be randomly chosen to receive PDT, while others are only treated with pleurectomy and adjuvant chemotherapy.
There have been many skeptics of photodynamic therapy when it comes to mesothelioma treatment. Some argue that previous studies need more research to determine if PDT is the actual reason for prolonged survival. Therefore, this study is designed to create a comparison of those who had PDT versus those who didn’t in order to judge whether PDT has a considerable effect.
Patients who are hesitant to participate in randomized clinical trials should speak with their doctor to determine if the trial is beneficial to them.
Who Is This Trial For?
This trial is recruiting up to 102 participants. However, not every patient is eligible for this clinical trial. Every trial has various inclusion and exclusion criteria that requires an evaluation by a mesothelioma specialist. Patients must also be aware of the risks and benefits of the trial, which should be explained by their specialist.
General eligibility criteria includes:
- Epithelioid cell type
- Must wait 30 days if previously treated by surgery, gene therapy or certain chemotherapy
- Must not have been treated with Alimta for 8 weeks
- Must be healthy enough for surgery (overall good lung function, cardiac function, etc.)
- Disease must be confined to the pleural cavity in the chest
This clinical trial is being conducted at these two cancer centers:
Principal Investigator: Dr. Keith Cengel
Intraoperative PDT for mesothelioma was pioneered at Abramson Cancer Center making it one of the only places in the world offering this therapy for mesothelioma patients. Dr. Cengel is a radiation oncologist with a complete understanding of the patient experience because he is cancer survivor himself. As he points out to his patients, “I know what it’s like to be sitting on the other side.”
Roswell Park Cancer Institute
Principal Investigator: Dr. Todd Demmy
Roswell Park Cancer Institute in Buffalo, NY is collaborating with the Abramson Cancer Center in this clinical trial as part of a multimillion dollar research grant for intraoperative PDT. Although Abramson first began using PDT in mesothelioma patients, Roswell Park is the cancer center that first developed PDT. Dr. Demmy is building on the tremendous results of previous mesothelioma patients treated with PDT to advance the treatment.
Is This Trial for You?
The Abramson Cancer Center is considered the hub for photodynamic therapy. This center is collaborating with Roswell Park with the help of a grant from the National Cancer Institute. If you are considering participating in this study, we can get you connected to one of the locations above that best fits your needs. Get connected to this clinical trial today.