TerminatedPhase 2NCT00165503

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

StatusTerminated
PhasePhase 2
U.S. locations2
SponsorDana-Farber Cancer Institute
01
Study overview

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
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

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.

04
Study sites

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.

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