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

Status:	Recruiting
Conditions:	Lung Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	4/21/2016
Start Date:	December 2015
Contact:	Marjorie Zauderer, MD
Phone:	646-888-4656

A Phase I Study of Concurrent Pemetrexed/Cisplatin With Pleural Intensity Modulated Radiation Therapy for Patients With Unresectable Malignant Pleural Mesothelioma

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.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

We found this trial at

sites

Memorial Sloan Kettering Cancer Center

1275 York Ave
New York, New York 10021

(212) 639-2000