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

Phase 1

Withdrawn

• Conditions: Malignant Pleural Mesothelioma
• Interventions: Drug: Pemetrexed/Cisplatin; Radiation: Pleural Intensity Modulated Radiation Therapy; Device: MRI

• Registration Number: NCT02639767
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-18
• Study First Submitted QC: 2015-12-21
• Study First Posted: 2015-12-24
• Status Verified: 2016-12
• Primary Completion: 2016-12
• Last Update Submitted: 2016-12-05
• Last Update Posted: 2016-12-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
pemetrexed/cisplatin with pleural IMRT	Pemetrexed/Cisplatin	This is a single institution phase I study of pemetrexed/cisplatin given concurrently with pleural intensity modulated radiation therapy (IMRT) in patients with unresectable malignant pleural mesothelioma (MPM). All patients will receive pleural intensity modulated radiation therapy (IMRT). Patients will be enrolled in cohorts of 3-6 at each dose level of pemetrexed/cisplatin, and dose escalation will proceed in a standard 3+3 fashion until the maximum tolerated dose (MTD) is identified.
pemetrexed/cisplatin with pleural IMRT	Pleural Intensity Modulated Radiation Therapy	This is a single institution phase I study of pemetrexed/cisplatin given concurrently with pleural intensity modulated radiation therapy (IMRT) in patients with unresectable malignant pleural mesothelioma (MPM). All patients will receive pleural intensity modulated radiation therapy (IMRT). Patients will be enrolled in cohorts of 3-6 at each dose level of pemetrexed/cisplatin, and dose escalation will proceed in a standard 3+3 fashion until the maximum tolerated dose (MTD) is identified.
pemetrexed/cisplatin with pleural IMRT	MRI	This is a single institution phase I study of pemetrexed/cisplatin given concurrently with pleural intensity modulated radiation therapy (IMRT) in patients with unresectable malignant pleural mesothelioma (MPM). All patients will receive pleural intensity modulated radiation therapy (IMRT). Patients will be enrolled in cohorts of 3-6 at each dose level of pemetrexed/cisplatin, and dose escalation will proceed in a standard 3+3 fashion until the maximum tolerated dose (MTD) is identified.

Primary Outcome Measures

Name	Time	Method
Dose limiting toxicities (DLT)	up to 12 weeks	The NCI Common Terminology Criteria for Adverse Events version 4.0 will be used to grade toxicities during the trial. DLTs are defined as any of the following events occurring during and for the first 12 weeks after completing pleural IMRT

Trial Locations

Locations (6)

Memorial Sloan Kettering at Basking Ridge; 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering at Mercy Medical Center; 🇺🇸 Rockville Centre, New York, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Cancer Center @ Suffolk; 🇺🇸 Commack, New York, United States

Memoral Sloan Kettering Cancer Center at Phelps; 🇺🇸 Sleepy Hollow, New York, United States

Memorial Sloan Kettering West Harrison; 🇺🇸 West Harrison, New York, United States