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

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ClinicalTrials.gov Identifier: NCT02639767
Recruitment Status : Withdrawn (Lack of accrual)
First Posted : December 24, 2015
Last Update Posted : December 7, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Malignant Pleural Mesothelioma Drug: Pemetrexed/Cisplatin Radiation: Pleural Intensity Modulated Radiation Therapy Device: MRI Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of Concurrent Pemetrexed/Cisplatin With Pleural Intensity Modulated Radiation Therapy for Patients With Unresectable Malignant Pleural Mesothelioma
Study Start Date : December 2015
Actual Primary Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma

Arm Intervention/treatment
Experimental: pemetrexed/cisplatin with pleural IMRT
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.
Drug: Pemetrexed/Cisplatin
Dose escalation of pemetrexed and cisplatin will follow the dose levels. The escalation will not exceed 500 mg/m^2 for pemetrexed in combination with 75 mg/m^2 of cisplatin even if the maximum tolerated dose is not identified. Each treatment cycle of chemotherapy will be 21 days. Patients will receive up to 2 cycles of chemotherapy during the radiation, and be followed for any DLT during the radiation therapy and for 12 weeks afterwards.

Radiation: Pleural Intensity Modulated Radiation Therapy
Pleura intensity modulated radiation therapy (IMRT) will be administered over approximately 6 weeks at 50.4 Gy in 28 fractions. The prescription radiation dose may anywhere between 45 and 50.4 Gy in 25 fractions if necessary to meet the normal tissue dose constraints.

Device: MRI
A pre-treatment MRI before chemo-RT will be acquired and will be used for target delineation. A three month post-treatment MRI will be acquired with the same protocol to assess the response from concurrent chemo-RT.




Primary Outcome Measures :
  1. Dose limiting toxicities (DLT) [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02639767


Locations
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United States, New Jersey
Memorial Sloan Kettering at Basking Ridge
Basking Ridge, New Jersey, United States, 07920
United States, New York
Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, United States, 11725
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
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, 10591
Memorial Sloan Kettering West Harrison
West Harrison, New York, United States, 10604
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Marjorie Zauderer Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02639767     History of Changes
Other Study ID Numbers: 15-304
First Posted: December 24, 2015    Key Record Dates
Last Update Posted: December 7, 2016
Last Verified: December 2016

Keywords provided by Memorial Sloan Kettering Cancer Center:
Pemetrexed
Cisplatin
Intensity Modulated Radiation Therapy
15-304

Additional relevant MeSH terms:
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Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Cisplatin
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors