Pleurectomy/Decortication With Intraoperative Intrathoracic/Intraperitoneal Heated Cisplatin With Sodium Thiosulfate
Stopped early · Phase 2
Conditions studied: Pleural Mesothelioma, Malignant Pleural Mesothelioma
In brief
The purposes of this study are: to determine the feasibility of administering adjuvant cisplatin plus ALIMTA to patients who undergo surgery with heated cisplatin during surgery; to determine the effects (good and bad) of this combined modality approach in patients with mesothelioma; to evaluate cisplatin effects by determining where it goes and how it is excreted in the body from the collection of tissues and cisplatin samples; to collect and analyze discarded samples of mesothelioma tumor during surgery to help determine the genetic make-up of the disease.
Key facts
- Study ID
- NCT00165503
- Run by
- Dana-Farber Cancer Institute
- People needed
- 16
- Starts
- 2004-04-01
- Expected to finish
- 2010-07-01
- Last updated by the study team
- 2016-09-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 or those with minimal disease
- Male on non-pregnant female
- 18 years of age or older
- No evidence of spread outside the ipsilateral hemithorax by chest CT and chest MRI
- Ejection fraction > 45%
- Pre-operative WBC > 4K/uL
- Estimated life expectancy of at least 12 weeks
- Evidence of adequate renal and hepatic function
- Grossly normal contralateral pulmonary function with a chest radiograph and chest CT scan
- Karnofsky performance status of 70% or greater
- No evidence of disease progression by chest CT or chest MRI, obtained at 8 weeks following surgery
You may not qualify if…
- Extended disease outside the ipsilateral hemithorax as determined on pre-operative radiographs or intraoperative findings
- Positive extrapleural nodes as determined by mediastinoscopy
- Gross disease (estimated thickness > 10mm at any intrathoracic location) present within the hemithorax after surgery
- Evidence of distant metastatic disease
- Severe non-malignant co-morbid disease, uncontrolled angina, myocardial infarction on the past 6 months, renal insufficiency, liver disease, pulmonary hypertension
- Pregnant or breast-feeding
- Serious concomitant systemic disorders
- Presence of active concomitant malignancy
- Psychiatric or addictive disorders, which would preclude informed consent
- Previous chemotherapy or radiation therapy for mesothelioma
- Chemotherapy or radiation therapy administered within 3 years for another malignancy
Where it is running
- Brigham and Women's Hospital — Boston, Massachusetts, United States
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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