Pleurectomy/Decortication With Intraoperative Intrathoracic/Intraperitoneal Heated Cisplatin With Sodium Thiosulfate
Condition: Pleural Mesothelioma; Malignant Pleural Mesothelioma
MeSH terms: Mesothelioma; Mesothelioma, Malignant
Intervention: Cisplatin; Sodium Thiosulfate; ALIMTA
Intervention MeSH terms: Sodium thiosulfate; Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: pleurectomy; decortication; cisplatin; ALIMTA

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.
    

Eligibility 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