Surgery, Chemotherapy, and Intensity Modulated Radiation Therapy in Treating Patients with Stage I-III Pleural Mesothelioma

  • Resize font
  • Print
  • Email
  • Facebook
  • Twitter
  • Google+
  • Pinterest

Basic Trial Information

PhaseTypeStatusAgeTrial IDs
Phase IITreatmentActive18 and over08-053
NCI-2016-01016, NCT00715611

Trial Description

Summary

This phase II trial studies the side effects of surgery, chemotherapy, and intensity modulated radiation therapy in treating patients with stage I-III pleural mesothelioma. Drugs used in chemotherapy, such as pemetrexed disodium, cisplatin, and carboplatin, work in different ways to stop the growth of cancer, either by killing the cancer cells, by stopping them from dividing, or by stopping them from spreading. Intensity modulated radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving chemotherapy before radiation therapy may help kill more tumor cells after surgery.

Further Study Information

PRIMARY OBJECTIVES:

I. To determine the safety and exportability of the Memorial Sloan Kettering Cancer Center (MSKCC) trimodality approach consisting of pleurectomy/decortication, adjuvant chemotherapy (neoadjuvant chemotherapy permissible as an alternative) and intensity modulated radiation therapy (IMRT) to the pleura in patients with malignant pleural mesothelioma as indicated by the incidence of >= grade 3 pneumonitis in a multi-institutional setting.

SECONDARY OBJECTIVES:

I. To determine the progression free and overall survival rates of patients with malignant pleural mesothelioma treated with lung-sparing trimodality therapy to the pleura.

II. To determine the pattern of progression: local recurrence versus metastatic disease.

III. To determine the incidence of any IMRT-related grade 2 or greater toxicity.

IV. To determine the impact of trimodality therapy and pleural IMRT on patient-reported outcomes (PRO-Common Terminology Criteria for Adverse Events [CTCAE]).

V. To develop a prediction model of resectability and a prognostic multi-modality imaging model through magnetic resonance imaging (MRI), positron emission tomography (PET) and computed tomography (CT) imaging.

OUTLINE:

Patients undergo pleurectomy/decortication (P/D). Within 4-8 weeks after surgery, patients receive pemetrexed sodium intravenously (IV) over 10 minutes and cisplatin IV over 60 minutes or carboplatin IV over 30 minutes. Treatment repeats every 21 days for up to 4 courses. Within 4-8 weeks of chemotherapy completion, patients undergo 28 fractions of IMRT over approximately 6 weeks.

After completion of study treatment, patients are followed up at 1 month, then every 3 months for 2 years.

Eligibility 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

No evidence of metastatic disease

Karnofsky performance status >= 80%

For all patients: diffusion capacity of the lungs for carbon monoxide (DLCO) > 40% predicted (corrected for hemoglobin [Hgb])

For patients enrolled prior to P/D, only: forced expiratory volume in 1 second (FEV1) >= 35% (corrected for Hgb) of predicted postoperative (ppoFEV1) (as if the patient underwent a pneumonectomy) based on the following formula using the quantitative ventilation/perfusion (V/Q) scan:

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

For patients enrolled post-P/D, only: FEV1 >= 35% (corrected for Hgb)

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

Absolute neutrophil count >= 1.5 K/mcL

Platelets >= 100 K/mcL

Serum total bilirubin =< 1.5 X upper limit of normal (ULN)

Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) or alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3.0 X ULN

Note: patients enrolled after chemotherapy do not have to meet the above criteria

Exclusion Criteria:

Sarcomatoid or desmoplastic histology

Continuous oxygen use

Prior nephrectomy on the contralateral side of malignant pleural mesothelioma (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

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

Memorial Sloan-Kettering Cancer Center

  • National Cancer Institute
Andreas Rimner, Principal Investigator

Trial Sites

U.S.A.

New Jersey
Basking Ridge

Memorial Sloan Kettering Cancer Center at Basking Ridge

Andreas Rimner
Ph: 212-639-6025
Email: rimnera@mskcc.org

Andreas Rimner
Principal Investigator

Middletown

Memorial Sloan Kettering Monmouth Monmouth

Andreas Rimner
Ph: 212-639-6025
Email: rimnera@mskcc.org

Andreas Rimner
Principal Investigator

New York
Commack

Memorial Sloan Kettering Cancer Center Commack

Andreas Rimner
Ph: 212-639-6025
Email: rimnera@mskcc.org

Andreas Rimner
Principal Investigator

New York

Memorial Sloan-Kettering Cancer Center

Andreas Rimner
Ph: 212-639-6025
Email: rimnera@mskcc.org

Andreas Rimner
Principal Investigator

Rockville Centre

Memorial Sloan Kettering Cancer Center Rockville Centre

Andreas Rimner
Ph: 212-639-6025
Email: rimnera@mskcc.org

Andreas Rimner
Principal Investigator

West Harrison

Memorial Sloan-Kettering Cancer Center West Harrison

Andreas Rimner
Ph: 212-639-6025
Email: rimnera@mskcc.org

Andreas Rimner
Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT00715611

Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.