Clinical Trial Details

NCT ID: NCT00715611
Date Last Changed: November 23, 2016

Overview

Research Study Summary

A clinical research study of Pemetrexed + Cisplatin or Carboplatin AUC=5 Pleurectomy/decortication (if feasible) Intensity Modulated Radiation Therapy for the treatment of Mesothelioma

Research Study 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

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.

To Learn more

Recruitment Details

Phase
2
Gender
Both Male and Female
Age
18 to 80 Years
Overall Status
Recruiting
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Duration
108 Months
Facility Type
N/A
Compensation

Eligibility

Both Male and Female ages 18 Years to 80 Years

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

  • No evidence of metastatic disease.

  • Patient age ≥ 18 years but ≤ 80 years at the time of consent.

  • Karnofsky performance status ≥ 80%

  • Pulmonary Function Tests:

  • FEV1 ≥ 35% (corrected for Hgb) of predicted postoperative (ppoFEV1) (as if the patient underwent a pneumonectomy) based on the following formula using the quantitative V/Q scan:

o Predicted post-resection FEV1 = FEV1 x % perfusion to uninvolved lung from the quantitative V/Q scan report

  1. DLCO > 40% predicted (corrected for Hgb)

  2. 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.

  3. Patient enrolled prior to chemotherapy must have adequate organ function as indicated by the following laboratory values:

  4. Absolute neutrophil count ≥1.5 K/mcL

  5. Platelets ≥100 K/mcL

  6. Serum total bilirubin ≤ 1.5 X ULN

  7. AST (SGOT) or ALT (SGPT) ≤ 3.0 X ULN Note: patients enrolled after chemotherapy do not have to meet the above criteria

  8. A minimal dataset must be acquired prior to enrollment for patients being registered after P/D and/or chemotherapy.

Exclusion Criteria:

  • 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.

Site Locations (7)

Country State City Zip Facility and Contact
United States New Jersey Basking Ridge 07920 Memorial Sloan Kettering at Basking Ridge
Andreas Rimner, MD
212-639-6025
United States New Jersey Middletown 07748 Memorial Sloan Kettering Monmouth
Andreas Rimner, MD
212-639-6025
United States New York Commack 11725 Memorial Sloan Kettering Cancer Center @ Suffolk
Andreas Rimner, MD
212-639-6025
United States New York New York 10065 Memorial Sloan Kettering Cancer Center
Andreas Rimner, MD
212-639-6025

Andreas Rimner, MD
Principal Investigator
United States New York Rockville Centre Memorial Sloan Kettering at Mercy Medical Center
Andreas Rimner, MD
212-639-6025
United States New York Sleepy Hollow 10591 Memorial Sloan Kettering Cancer Center at Phelps Memorial Hospital Center
Andreas Rimner, MD
212-639-6025
United States New York West Harrison 10604 Memorial Sloan Kettering West Harrison
Andreas Rimner, MD
212-639-6025

Contact

Andreas Rimner, MD
212-639-6025

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