Recruiting Multimodal Trial Gives Hope to Pleural Mesothelioma Surgical Candidates
Type: Pleural Mesothelioma
Researchers believe that using atezolizumab, pemetrexed disodium, and cisplatin may be beneficial in treating pleural mesothelioma. In this study, investigators will be evaluating the use of these drugs before and after surgery. Some candidates may also experience radiation therapy.
Treating Mesothelioma with Multimodal Therapy
Researchers will be studying how patients respond to being treated with atezolizumab, pemetrexed disodium, and cisplatin when paired with surgery. Participants in this study may or may not have radiation therapy included in their treatment.
Atezolizumab – is a monoclonal antibody. Atezolizumab is an immunotherapy drug that works with the immune system to help target and kill cancer cells inside of the body. It is commonly used in patients that have their disease worsen after experiencing chemotherapy.Pemetrexed disodium – is a chemotherapy drug that is typically paired with the drug cisplatin when treating mesothelioma. It works by attaching to PD-L1 proteins that are expressed by cancer cells and the immune system. By blocking this protein, it is able to attack a patient’s cancer cells.
Cisplatin – this anti-cancer chemotherapy drug classified as an alkylating agent. It works by damaging cancer cells so they cannot divide, which causes them to ultimately die.
Investigators believe that giving the combination of atezolizumab, pemetrexed disodium, and cisplatin before surgery may help shrink a patient’s tumor. Researchers also anticipate that continuing the administration of atezolizumab after surgery will help kill any remaining cancer cells that weren’t removed during a patient’s surgical operation.
Get Help Enrolling in This Trial
Reasons to get involved in this trial include:
- Receive proven life-extending treatment
- Trial is recruiting in over 100 different cancer centers in the country
- Surgical candidates will receive treatment before and after surgery
Treating Surgical Candidates with Chemotherapy, Immunotherapy & Randomized Radiation
This trial is currently accepting patients that have either biphasic or epithelioid mesothelioma.
A participant will have to agree to all terms of the study to be a successful candidate.
There are 3 parts of this study that researchers will be evaluating:
- Neoadjuvant (Before surgery)
- Maintenance (After surgery)
All clinical trial candidates will receive the same neoadjuvant treatment. After surgery, randomized participants may experience a treatment plan that includes radiation therapy.
Leading up to surgery a patient will be given atezolizumab, pemetrexed disodium, and cisplatin. All of these drugs will be administered by IV.
Drug dosing times are as follows:
- Atezolizumab will be given over 60 to 90 minutes
- Pemetrexed disodium will be administered over 10 minutes
- Cisplatin will be dosed over 2 hours on day 1
Every 21 days this treatment cycle will repeat if a patient’s disease remains progression free. Researchers anticipate that each participant will complete the treatment cycle 4 times.
The next phase of the trial includes the patient having surgery. Each participant will have either an EPP or P/D procedure. Patients that are undergoing EPP who qualify for radiation therapy will be eligible to begin treatment 4 to 8 weeks after their procedure.
6 to 8 weeks after surgery, or surgery plus radiation, patients will continue to receive the drug atezolizumab. Participants will be given the drug for 60 minutes on day 1 of a 21-day repeating cycle. Individuals that do not experience any levels of toxicity or have their disease progress will continue to receive this form of treatment up to 1 year.
Is This Trial for You?
This Phase 1 clinical trial is sponsored by the National Cancer Institute and is currently accepting pleural mesothelioma patients. The study is recruiting in 112 different locations in 16 states and anticipates to enroll about 28 participants.
Researchers will be analyzing a patient’s progression-free survival as well as overall survival rate. To guarantee the safety of participants in this trial, a patient must meet certain criteria.
Some requirements include:
- Confirmed diagnosis of malignant pleural mesothelioma
- Stage 1-3
- Patient has planned to have either pleurectomy decortication (P/D) or extrapleural pneumonectomy (EPP) procedure
- Must have either epithelioid or biphasic mesothelioma cell type
- No prior treatment of immunotherapy or chemotherapy for mesothelioma
For more information about qualifications for this clinical trial, please contact patient advocate Jenna Campagna. You can reach her at 888-385-2024 extension 102.
Get to Know the Lead Investigator
Head of this clinical trial is pleural mesothelioma specialist Dr. Anne Tsao. Dr. Tsao is the director of the Mesothelioma Program at MD Anderson Cancer Center.
Dr. Anne Tsao has been involved in and has led many studies that aim to improve treatment options for mesothelioma patients. She is involved in may oncology societies, including the Southwest Oncology Group (SWOG).
SWOG is a cancer research community that creates and conducts publicly funded clinical trials. This organization has been around since 1956. Its focus is to test new treatments, develop prevention techniques, and alternative methods of caring for cancer survivors.