Concurrent Pemetrexed/Cisplatin With Pleural Intensity Modulated Radiation Therapy for Patients With Unresectable Malignant Pleural Mesothelioma

Withdrawn before enrolling · Phase 1

Conditions studied: Malignant Pleural Mesothelioma

In brief

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 as chemotherapy 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.

Key facts

Study ID

NCT02639767

Run by

Memorial Sloan Kettering Cancer Center

People needed

0

Starts

2015-12-01

Last updated by the study team

2016-12-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pathologically confirmed diagnosis of malignant pleural mesothelioma at MSKCC
• No plans for surgical resection
• Stage T1-4, N0-3, M0
• No prior radiation therapy to the chest, breast or supraclavicular fossa that would limit radiation delivery to the full prescription dose
• Prior chemotherapy regimens ≤1
• Age ≥18 years
• 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 creatinine clearance (CrCl) ≥ 45mL/min (using Cockcroft \& Gault method)
• Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) (unless known Gilbert's disease)
• AST (SGOT) and ALT (SGPT) ≤ 3.0 x ULN

You may not qualify if…

• 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 moved
• Patients meeting the following exclusion criteria will be excluded from the MRI portion only:
• Metallic implant, e.g. pacemaker, defibrillator
• Unmanageable claustrophobia
• High risk for nephrogenic systemic fibrosis

Where it is running

• Memorial Sloan Kettering at Basking Ridge — Basking Ridge, New Jersey, United States
• Memorial Sloan Kettering Cancer Center @ Suffolk — Commack, New York, United States
• Memorial Sloan Kettering West Harrison — East White Plains, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Memorial Sloan Kettering at Mercy Medical Center — Rockville Centre, New York, United States
• Memoral Sloan Kettering Cancer Center at Phelps — Sleepy Hollow, New York, United States

Full record on ClinicalTrials.gov

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