For mesothelioma patients and families that are interested in clinical trials, researching clinical trials and eligibility can be a time consuming barrier to participation. The information about clinical trials is available on www.clinicaltrials.gov.
Our goal is to feature one mesothelioma clinical trial monthly and break it down to understandable terms, to decipher the eligibility requirements, and to possibly encourage participation in these trials.
Listing: ClinicalTrial.gov – NCT02639767
Official Title: Concurrent Pemetrexted/ Cisplatin With Pleural Intensity Modulated Radiation Therapy for Patients With Unrespectable Malignant Pleural Mesothelioma
Sponsor: Memorial Sloan Kettering Cancer Center
Location: Memorial Sloan Kettering Cancer Center
Principle Investigator: Marjorie Zauderer MD Memorial Sloan Kettering Cancer Center
Contact: Marjorie Zauderer M.D. 646 888 4656
Andreas Rimner M.D. 212 639 6025
Purpose: The purpose of this study is to evaluate the safety of combining chemotherapy at different doses with a specific type of radiation therapy delivered to the entire lining of the lung to find out what effects, if any, it has on people. This radiation technique is called pleural intensity modulated radiation therapy (IMRT). IMRT specifically targets the lining of the lung (pleura) where the cancer is and reduces the risk of damaging the lung itself. When given after chemotherapy, pleural IMRT has demonstrated promising results with respect to keeping mesothelioma under control longer. However, the investigators want to determine if giving pleural IMRT at the same time is safe. If safe, further studies will be done to see if chemotherapy and pleural IMRT given at the same time keeps the tumor under control for a longer period of time than chemotherapy followed by pleural IMRT.
Screening: Screening Tests- Pre- treatment MRI before chemo and radiation therapy and will be used for target delineation. Three-month post treatment MRI will be acquired to assess the response from the treatment
Eligibility: Must be pathologically confirmed diagnosis of malignant pleural mesothelioma at Memorial Sloan Kettering Cancer Center
- No plans for surgery
- Stage T1-4, NO-3, M0
- No prior radiation therapy to the chest, breast or supraclavicular fossa that would limit radiation delivery to the full prescription dose
- Prior chemotherapy < 1 • Age >18
- Karnofsky performance status >80%
- Pulmonary function tests as follows: DLCO>50% predicted
- Adequate hematologic, hepatic, and renal function as indicated by the following laboratory values
- Absolute neutrophil count > 1,500/mcl
- Platelets > 100,000/mcl
- Calculated creatine clearance (CrCl) > 45ml/min
- Serum total bilirubin < 1.5 x upper limit of normal
- ASt (SGOT) and ALT (SGPT) < 3.0 x upper limits normal
- Pregnant or lactating women, or men or women not using effective contraception
- Patients with an active infection that requires systemic antibiotics, antiviral, or antifungal treatments
- Patients with a concurrent active malignancy (with the exception of skin cancer)
- Patients with serious unstable medical illness
- Patients with idiopathic pulmonary fibrosis
- Patients with NYHA heart failure class >2
- Patients with only one kidney that is ipsilateral to the mesothelioma
- Implanted pacemaker and/or defibrillator ipsilateral to the mesothelioma if it cannot be removed
- Patients meeting the following exclusion criteria will be excluded from the MRI portion only
- Metallic implant, e.g. pacemaker, defibrillator
- Unmanageable claustrophobia
- High risk nephrogenic systemic fibrosis
How the Research Study is Designed to Work- IMRT is a very targeted treatment It is thought that using the two treatments together will improve survival
With any clinical trial all participation is voluntary. Before enrollment a detailed consent form will be reviewed with the participant and signed. The participant can withdraw from a clinical trial at any point in time. Think about participating if able, the only way to progress to a cure for mesothelioma is through clinical trials.
Please do not hesitate to contact us with any questions.
What is IMRT? Intensity modulated radiation therapy is an advanced form of radiation therapy. Before IMRT patients were radiated in specific areas such as the chest, the radiation was directed at tumors but unfortunately would include healthy tissue. The way it works is that by using computer controlled linear accelerators precise doses of radiation are able to be delivered to a tumor. It targets a specific area within the tumor, by controlling the intensity of the radiation beam to the volume of the tumor. It concentrates the beam in the region within the tumor while minimizing the dose to the surrounding area. This is done by using a CT. Scan or MRI image of the tumor, by doing some computer calculations and 3-D imaging to figure out what dose will conform to the tumor depth and shape. The treatment is usually multiple beams coming from different directions, the dose is customized while minimizing the dose to the adjacent normal tissue.
Pemetrexed/ Cisplatin is the only FDA approved first line chemotherapy for mesothelioma. By combining these therapies within the same time frame the researches are planning to study if working together they improve response and keep the mesothelioma under control for a longer period than if administered seperalty.
This study is being conducted at Memorial Sloan Kettering only. Patients have to be deemed not a candidate for surgery.