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Pleurectomy/Decortication (Neo) Adjuvant Chemotherapy and Intensity Modulated Radiation Therapy to the Pleura in Patients With Locally Advanced Malignant Pleural Mesothelioma

This study is currently recruiting participants.
Verified October 2017 by Memorial Sloan Kettering Cancer Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT00715611
First Posted: July 15, 2008
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
M.D. Anderson Cancer Center
Princess Margaret Hospital, Canada
Mayo Clinic
Brigham and Women's Hospital
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
  Purpose
For patients with this type of cancer, the standard of care is treatment with chemotherapy. Radiation therapy is typically not used. This is because radiation to the entire lining of the lung has many side effects that are often severe including damage to the lung (pneumonitis). There is a new radiation technique using Intensity Modulated Radiation Therapy (IMRT) that has been shown to reduce many of the side effects of standard radiation therapy. This type of radiation therapy specifically targets the lining of the lung, where you have your cancer, and reduces the risk of damaging the lung itself. The purpose of this study is to test the safety and implementation of standard pleurectomy/decortication (removal of the surface lining of the lung) performed at other centers. Patients will undergo pleurectomy/decortication chemotherapy and hemithoracic pleural IMRT to the pleura in patients with malignant pleural mesothelioma.

Condition Intervention Phase
Mesothelioma Procedure: Pleurectomy/Decortication Drug: pemetrexed and cisplatin or carboplatin Radiation: Intensity Modulated Radiation Therapy Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Toxicity Study of Pleurectomy/Decortication, (Neo) Adjuvant Chemotherapy and Intensity Modulated Radiation Therapy to the Pleura in Patients With Locally Advanced Malignant Pleural Mesothelioma

Resource links provided by NLM:


Further study details as provided by Memorial Sloan Kettering Cancer Center:

Primary Outcome Measures:
  • number of patients ≥ grade 3 pneumonitis [ Time Frame: 2 years ]
    Grade 3 pneumonitis is defined as symptomatic, interfering with ADL's and requiring oxygen support as defined by the NCI Common Terminology Criteria (CTC) version 4.0 for toxicity and Adverse Event reporting.


Estimated Enrollment: 81
Study Start Date: July 11, 2008
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
This is a multicenter phase II toxicity study of pleurectomy/decortication (P/D) followed by adjuvant chemotherapy and Intensity Modulated Radiation Therapy (IMRT) to the pleura in patients with malignant pleural mesothelioma. Alternatively, chemotherapy may be administered in the neoadjuvant setting prior to P/D, followed by IMRT. Patients deemed resectable at the time of enrollment will undergo P/D with the goal of a macroscopic complete resection (MCR). Those with disease progression or severe toxicity will stop chemotherapy and undergo a PET scan.
Procedure: Pleurectomy/Decortication
Pleurectomy/decortication will be performed as per standard technique
Other Name: (P/D)
Drug: pemetrexed and cisplatin or carboplatin
The combination of pemetrexed and cisplatin or carboplatin will be given every 3 weeks for up to 4 cycles. Pemetrexed will be administered at 500mg/m2 as a 10-minute infusion. Cisplatin will be administered at 75mg/m2 as a 60-minute infusion. Carboplatin will be administered at an AUC of 5 over 30 minutes. Chemotherapy may be administered in the neoadjuvant or adjuvant setting.
Radiation: Intensity Modulated Radiation Therapy
IMRT will be administered over approximately 6 weeks at 50.4 Gy in 28 fractions with an optional SIB to gross residual disease (pending meeting normal tissue constraints).
Other Name: IMRT

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provide written informed consent to participate on the study
  • Patients must have a pathologically confirmed diagnosis either at MSKCC or at the participating site of stage I-III malignant pleural mesothelioma
  • Epithelioid or biphasic histology subtype (Note: patients with biphasic histology can have < 10% sarcomatoid)
  • No evidence of metastatic disease.
  • Patient age ≥ 18 years but ≤ 80 years at the time of consent.
  • Karnofsky performance status ≥ 80%
  • Pulmonary Function Tests:

    1. For all patients: DLCO > 40% predicted (corrected for Hgb)
    2. For patients enrolled post-P/D, only: FEV1 >/= 35% (corrected for Hgb) (Note: patients enrolled prior to P/D will have PFTs repeated pre-IMRT. If this criteria is not met, they will be removed from study)
  • In cases of concern about decreased renal function and potential high radiation dose to the kidneys, an optional nuclear medicine kidney function scan may be performed prior to radiation therapy to determine the functional contribution of each kidney.
  • Patient enrolled prior to chemotherapy must have adequate organ function as indicated by the following laboratory values:

    1. Absolute neutrophil count ≥1.5 K/mcL
    2. Platelets ≥100 K/mcL
    3. Serum total bilirubin ≤ 1.5 X ULN
    4. AST (SGOT) or ALT (SGPT) ≤ 3.0 X ULN Note: patients enrolled after chemotherapy do not have to meet the above criteria

Exclusion Criteria:

  • > 10% Sarcomatoid or desmoplastic histology
  • Continuous oxygen use
  • Prior nephrectomy on the contralateral side of MPM
  • Prior intrapleural therapy (except pleurodesis) or intrapleural therapy at the time of P/D (i.e.: intrapleural chemotherapy, photodynamic therapy, intrapleural betadine)
  • Prior thoracic radiation therapy preventing hemithoracic pleural IMRT
  • Bulky disease in the fissure preventing lung-sparing pleural IMRT
  • Patients undergoing extrapleural pneumonectomy
  • Patients with an active infection that require systemic antibiotics, antiviral, or antifungal treatments
  • Patients with a concurrent active malignancy (except squamous or basal cell carcinoma of the skin)
  • Patients with serious unstable medical illness
  • Presence of third space fluid that cannot be controlled by drainage
  • For patients who develop or have baseline clinically significant pleural effusions before or during initiation of pemetrexed therapy; consideration should be given to drain the effusion prior to chemotherapy administration
  • No acute congestive heart failure
  • Pregnant or lactating women
  • Men or women not using effective contraception

Reproductive risks Patients should not become pregnant or father a baby while on this study because the drugs in this study can affect an unborn baby. Women should not breast-feed a baby while on this study. Women of childbearing age will be counseled to use birth control while on this study.

  Contacts and Locations
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): NCT00715611


Contacts
Contact: Andreas Rimner, MD 212-639-6025
Contact: Valerie Rusch, MD 212-639-5873

Locations
United States, New Jersey
Memorial Sloan Kettering at Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Andreas Rimner, MD    212-639-6025      
Memorial Sloan Kettering Monmouth Recruiting
Middletown, New Jersey, United States, 07748
Contact: Andreas Rimner, MD    212-639-6025      
United States, New York
Memorial Sloan Kettering Cancer Center @ Suffolk Recruiting
Commack, New York, United States, 11725
Contact: Andreas Rimner, MD    212-639-6025      
Memorial Sloan Kettering West Harrison Recruiting
Harrison, New York, United States, 10604
Contact: Andreas Rimner, MD    212-639-6025      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Andreas Rimner, MD    212-639-6025      
Contact: Valerie Rusch, MD    212-639-5873      
Principal Investigator: Andreas Rimner, MD         
Memorial Sloan Kettering at Mercy Medical Center Recruiting
Rockville Centre, New York, United States
Contact: Andreas Rimner, MD    212-639-6025      
Memorial Sloan Kettering Cancer Center at Phelps Memorial Hospital Center Recruiting
Sleepy Hollow, New York, United States, 10591
Contact: Andreas Rimner, MD    212-639-6025      
United States, Texas
Md Anderson Cancer Center Active, not recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
M.D. Anderson Cancer Center
Princess Margaret Hospital, Canada
Mayo Clinic
Brigham and Women's Hospital
Investigators
Principal Investigator: Andreas Rimner, MD Memorial Sloan Kettering Cancer Center
  More Information

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00715611     History of Changes
Other Study ID Numbers: 08-053
First Submitted: July 11, 2008
First Posted: July 15, 2008
Last Update Posted: October 12, 2017
Last Verified: October 2017

Keywords provided by Memorial Sloan Kettering Cancer Center:
pemetrexed
cisplatin
IMRT
PLEURA
Malignant
08-053

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