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Extrapleural Pneumonectomy With Intraoperative Intrathoracic/Intraperitoneal Heated Cisplatin With Amifostine and Sodium Thiosulfate

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ClinicalTrials.gov Identifier: NCT00165516
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : March 27, 2014
Sponsor:
Collaborator:
Brigham and Women's Hospital
Information provided by (Responsible Party):
Dana-Farber Cancer Institute

Brief Summary:
The purposes of this study are: to evaluate the effects (good and bad) that administering heated cisplatin into the chest and abdomen cavity following surgical resection has on malignant mesothelioma; to collect data on the toxicity of cisplatin given directly into the chest and abdomen, and the levels of the cisplatin in the body; to determine if this treatment method has the possibility of helping patients with pleural mesothelioma live longer; and to determine if this treatment method can help decrease the rate of local recurrence of mesothelioma.

Condition or disease Intervention/treatment Phase
Pleural Mesothelioma Malignant Pleural Mesothelioma Drug: Cisplatin Drug: Sodium Thiosulfate Phase 2

Detailed Description:
  • Patients will undergo surgery called extrapleural pneumonectomy which involves removal of the lung, the lining of the lung, the covering of the heart, and the muscle that separates the chest and abdomen. At the conclusion of the resection, if the patient has less then 1 cm3 of residual gross disease in one or more areas, then the heated chemotherapy lavage will begin. If more than this volume of disease is present, then the patient will receive additional treatment off-study.
  • The chemotherapy treatment consists of a one-hour lavage of the chest and abdomen cavity with heated cisplatin given in the operating room through the surgical incision. At the completion of the hour, sodium thiosulfate is given intravenously to reduce the potential side effects of cisplatin.
  • During the surgery and for four hours following the completion of the cisplatin lavage, blood samples, urine samples, chest wall muscle samples, and samples of the chemotherapy solution will be done in order to measure the concentration of chemotherapy and the impact of cisplatin on the various cell samples.
  • Patients will remain in the hospital until they have recovered from surgery (7-14 days). Following discharge from the hospital, patients will be seen 1-2 weeks post-operatively for blood tests. 6 weeks later additional blood tests and and echocardiogram will be performed. This echocardiogram will be repeated 6 months post-operatively to re-assess heart function.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Feasibility Study of Extrapleural Pneumonectomy With Intraoperative Intrathoracic/Intraperitoneal Heated Cisplatin With Amifostine and Sodium Thiosulfate
Study Start Date : January 2004
Actual Primary Completion Date : July 2006
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma


Intervention Details:
  • Drug: Cisplatin
    Heated and given as an one-hour lavage of the chest and abdomen during surgery
  • Drug: Sodium Thiosulfate
    After the one-hour lavage, sodium thiosulfate is given intravenously


Primary Outcome Measures :
  1. To monitor tumor recurrence and patient survival, and compare those results to historic controls.

Secondary Outcome Measures :
  1. To document the morbidity and mortality of this treatment protocol in this patient population [ Time Frame: 3 years ]
  2. to evaluate the pharmacokinetics of cisplatin. [ Time Frame: 3 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male of non-pregnant female 18 years of age or older
  • HIstopathologic confirmation of malignant pleural mesothelioma
  • Ejection fraction > 45%
  • Evidence of adequate renal and hepatic function
  • Grossly normal contralateral pulmonary function with a chest radiograph and chest CT scan that do not show acute infiltrates
  • FEV1 > or = to 2.0L on a preoperative pulmonary function test
  • Karnofsky performance status of 70% or greater

Exclusion Criteria:

  • Extended disease outside the ipsilateral hemithorax as determined by pre-operative radiographs or intraoperative findings
  • Positive extrapleural nodes as determined by mediastinoscopy
  • Positive LENIs
  • Gross disease present within the hemithorax after surgery
  • Evidence of distant metastases
  • Severe non-malignant co-morbid disease: uncontrolled angina, myocardial infarction in the past 6 months, renal insufficiency, liver disease, pulmonary hypertension
  • Presence of active concomitant malignancy
  • Patients with a psychiatric or addictive disorder which would preclude informed consent
  • Previous chemotherapy or radiation therapy to treat mesothelioma
  • Chemotherapy or radiation therapy administered within 3 years for another malignancy

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): NCT00165516


Locations
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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Investigators
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Principal Investigator: David J. Sugarbaker, MD Brigham and Women's Hospital

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Responsible Party: Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00165516     History of Changes
Other Study ID Numbers: 03-302
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: March 27, 2014
Last Verified: March 2014
Keywords provided by Dana-Farber Cancer Institute:
Extrapleural pneumonectomy
cisplatin
heated cisplatin
Additional relevant MeSH terms:
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Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Sodium thiosulfate
Cisplatin
Amifostine
Antineoplastic Agents
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Antidotes
Antioxidants
Molecular Mechanisms of Pharmacological Action
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Chelating Agents
Sequestering Agents