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

Primary Purpose

Malignant Pleural Mesothelioma

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Pemetrexed/Cisplatin
Pleural Intensity Modulated Radiation Therapy
MRI
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Pleural Mesothelioma focused on measuring Pemetrexed, Cisplatin, Intensity Modulated Radiation Therapy, 15-304

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan Kettering at Basking Ridge
  • Memorial Sloan Kettering Cancer Center @ Suffolk
  • Memorial Sloan Kettering Cancer Center
  • Memorial Sloan Kettering at Mercy Medical Center
  • Memoral Sloan Kettering Cancer Center at Phelps
  • Memorial Sloan Kettering West Harrison

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

pemetrexed/cisplatin with pleural IMRT

Arm Description

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.

Outcomes

Primary Outcome Measures

Dose limiting toxicities (DLT)
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

Secondary Outcome Measures

Full Information

First Posted
December 18, 2015
Last Updated
December 5, 2016
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT02639767
Brief Title
Concurrent Pemetrexed/Cisplatin With Pleural Intensity Modulated Radiation Therapy for Patients With Unresectable Malignant Pleural Mesothelioma
Official Title
A Phase I Study of Concurrent Pemetrexed/Cisplatin With Pleural Intensity Modulated Radiation Therapy for Patients With Unresectable Malignant Pleural Mesothelioma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of accrual
Study Start Date
December 2015 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Pleural Mesothelioma
Keywords
Pemetrexed, Cisplatin, Intensity Modulated Radiation Therapy, 15-304

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pemetrexed/cisplatin with pleural IMRT
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Pemetrexed/Cisplatin
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
Pleural Intensity Modulated Radiation Therapy
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
MRI
Intervention Description
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 Measure Information:
Title
Dose limiting toxicities (DLT)
Description
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
Time Frame
up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marjorie Zauderer
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering at Basking Ridge
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center @ Suffolk
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Memorial Sloan Kettering at Mercy Medical Center
City
Rockville Centre
State/Province
New York
Country
United States
Facility Name
Memoral Sloan Kettering Cancer Center at Phelps
City
Sleepy Hollow
State/Province
New York
ZIP/Postal Code
10591
Country
United States
Facility Name
Memorial Sloan Kettering West Harrison
City
West Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.mskcc.org/
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

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

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