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



Status:Recruiting
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 80
Updated:10/12/2018
Start Date:October 11, 2008
End Date:July 2019
Contact:Andreas Rimner, MD
Phone:212-639-6025

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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

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) and standard chemotherapy followed by IMRT performed at other
centers. Patients will undergo pleurectomy/decortication chemotherapy and hemithoracic
pleural IMRT to the pleura in patients with malignant pleural mesothelioma.


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.
We found this trial at
12
sites
Middletown, New Jersey 07748
Phone: 212-639-6025
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Phone: 617-632-3591
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Basking Ridge, New Jersey 07920
Phone: 212-639-6025
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Commack, New York 11725
Phone: 212-639-6025
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500 Westchester Avenue
Harrison, New York 10604
Phone: 212-639-6025
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Houston, Texas 77030
Principal Investigator: Daniel Gomez, MD
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225 Summit Avenue
Montvale, New Jersey 07645
Phone: 212-639-6025
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Andreas Rimner, MD
Phone: 212-639-6025
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Phone: 507-538-3270
Mayo Clinic Cancer Center The Mayo Clinic Cancer Center is a National Cancer Institute-designated comprehensive...
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Rochester, MN
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1000 N Village Ave
Rockville Centre, New York 11570
(516) 256-3600
Phone: 212-639-6025
Memorial Sloan-Kettering at Mercy Medical Center Memorial Sloan Kettering Cancer Center Rockville Centre provides state-of-the-art...
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701 N Broadway
Sleepy Hollow, New York 10591
(914) 366-3000
Phone: 212-639-6025
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center Memorial Sloan Kettering Cancer Center Sleepy...
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Tampa, Florida 33612
Principal Investigator: Bradford Perez, MD
Phone: 888-663-3488
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Tampa, FL
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