Pleurectomy/Decortication With Intraoperative Intrathoracic/Intraperitoneal Heated Cisplatin With Sodium Thiosulfate

• Status: Terminated
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborator: Brigham and Women's Hospital
• Treatments: Cisplatin; Pemetrexed; Sodium thiosulfate

Criteria

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 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

Exclusion Criteria:

• 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