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

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedPemetrexed/Cisplatin and Pleural Intensity Modulated Radiation Therapy

Plus 1 other study approaches.

Who it may be forMesothelioma · Early-stage or resectable

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Dec 7, 2016 · Source: ClinicalTrials.gov

Is enrollment open?Withdrawn

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?6 U.S. locations

Locations may change over time.

Who runs it?Memorial Sloan Kettering Cancer Center

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1
Sponsor: Memorial Sloan Kettering Cancer Center
Interventions being studied: Drug: Pemetrexed/Cisplatin; Radiation: Pleural Intensity Modulated Radiation Therapy; Device: MRI

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Mesothelioma→

Disease setting

Early-stage or resectable→

Treatment approach

Chemotherapy→Radiation therapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Memorial Sloan Kettering at Basking RidgeBasking Ridge, New Jersey
Memorial Sloan Kettering Cancer Center @ SuffolkCommack, New York
Memorial Sloan Kettering West HarrisonEast White Plains, New York
Memorial Sloan Kettering Cancer CenterNew York, New York
Memorial Sloan Kettering at Mercy Medical CenterRockville Centre, New York
Memoral Sloan Kettering Cancer Center at PhelpsSleepy Hollow, New York

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 7, 2016. Always confirm current availability with the study team.

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