Pleurectomy/Decortication With Intraoperative Intrathoracic/Intraperitoneal Heated Cisplatin With Sodium Thiosulfate
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.
Checked against the public recordLast updated Sep 9, 2016 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Diagnostic
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Dana-Farber Cancer Institute
- Interventions being studied
- Drug: Cisplatin; Drug: Sodium Thiosulfate; Drug: ALIMTA
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Brigham and Women's HospitalBoston, Massachusetts
- Dana-Farber Cancer InstituteBoston, Massachusetts
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 9, 2016. Always confirm current availability with the study team.