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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 1 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Sep 9, 2016 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
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
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
- 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.