Pleurectomy/Decortication Followed by Intrathoracic/Intraperitoneal Heated Cisplatin for Malignant Pleural Mesothelioma
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ClinicalTrials.gov Identifier: NCT00165555 |
Recruitment Status
:
Completed
First Posted
: September 14, 2005
Last Update Posted
: March 27, 2014
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pleural Mesothelioma Malignant Pleural Mesothelioma | Drug: Cisplatin Drug: Sodium Thiosulfate | Phase 1 |
- Patients will undergo surgery with pleurectomy/decortication which entails the removal of the inner and outer skin of the lung, including the pleura overlying the pericardium and diaphragm. Resection of the pericardium and diaphragm are occasionally necessary to debulk the tumor. This surgery is part of standard care for pleural mesothelioma.
- After surgery, a one hour lavage with heated cisplatin will be administered to the hemithorax (and abdominal regions if the diaphragm is no longer present). The lung itself is not removed, only the diseased portion of the lung and surrounding areas with tumor.
- Immediately following the one-hour lavage, a six hour infusion of sodium thiosulfate will begin to help reduce the side effects of the cisplatin.
- Patients will remain hospitalized until they have recovered from surgery (usually 7-14 days).
- Patients will return to the hospital three months after their surgery to have fluid drawn from their chest via an ultrasound guided thoracentesis. This is called a saline wash.
- Patients will be in the study actively for three months. This includes a 2-week and 4-week post-operative follow-up in which blood work is performed. As well as a 3-month follow-up for the saline wash. Long-term follow-up includes computed tomography of the chest and abdomen every 6 months to assess recurrence.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 70 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Pleurectomy/Decortication Followed by Intrathoracic/Intraperitoneal Heated Cisplatin and Intravenous Sodium Thiosulfate in the Multimodality Treatment of Malignant Pleural Mesothelioma |
Study Start Date : | August 1999 |
Actual Primary Completion Date : | April 2002 |
Actual Study Completion Date : | November 2009 |

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Drug: Cisplatin
- To determine the maximally tolerated dose of intracavitary cisplatin in patients with malignant pleural mesothelioma, [ Time Frame: 3 years ]
- To quantitate the safety of intraoperative intrathoracic/intraperitoneal hyperthermic cisplatin [ Time Frame: 3 years ]
- to study the pharmacokinetics of cisplatin administered in this way. [ Time Frame: 3 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histopathologic confirmation of malignant pleural mesothelioma
- Patients who are able to tolerate surgical cytoreduction but unable to undergo extrapleural pneumonectomy due to poor cardiopulmonary reserve or tumor invasion
- 18 years of age or older
- Malignancy is confined to the affected hemithorax.
- Grossly normal cardiac function with an EKG showing no cardiomyopathy or acute changes
- Evidence of adequate renal and hepatic function
- Karnofsky performance status of 70% or greater
Exclusion Criteria:
- Extended disease outside the ipsilateral hemithorax as determined radiologically and intraoperatively
- Distant metastases
- Non-malignant systemic disease
- Active concomitant malignancy
- Psychiatric or addictive disorders which would preclude obtaining informed consent
- Prior treatment within the last 2 months, other than surgical resection for their current malignancy

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): NCT00165555
United States, Massachusetts | |
Brigham and Women's Hospital | |
Boston, Massachusetts, United States, 02115 | |
Dana-Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | David J. Sugarbaker, MD | Brigham and Women's Hospital |
Responsible Party: | Dana-Farber Cancer Institute |
ClinicalTrials.gov Identifier: | NCT00165555 History of Changes |
Other Study ID Numbers: |
99-124 |
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:
cisplatin pleurectomy decortication heated cisplatin |
Additional relevant MeSH terms:
Mesothelioma Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Mesothelial Cisplatin Sodium thiosulfate Antineoplastic Agents Antidotes |
Protective Agents Physiological Effects of Drugs Antioxidants Molecular Mechanisms of Pharmacological Action Antitubercular Agents Anti-Bacterial Agents Anti-Infective Agents Chelating Agents Sequestering Agents |