Extrapleural Pneumonectomy /Pleurectomy Decortication, IHOC Cisplatin and Gemcitabine With Amifostine and Sodium Thiosulfate Cytoprotection for Resectable Malignant Pleural Mesothelioma

Study summary

RATIONALE: After removal of visible cancer in the chest, chemotherapy drugs are used to kill or stop tumor cells from dividing, so that they stop growing or/and die. Cisplatin is currently used safely as in intra-operative treatment for malignant pleural mesothelioma. This study is aimed to determine if the addition of gemcitabine as a second intracavitary chemotherapy can be accomplished safely. PURPOSE: This is a Phase I trial to study the efficacy of combination chemotherapy consisting of gemcitabine and cisplatin administered in the operating room and put into the chest and abdomen for one hour. We are also looking at the effects of heating the chemotherapy to a temperature of 42 degrees Celsius and the effect of cytoprotection agents: amifostine and sodium thiosulfate to counteract potential side effects of chemotherapy.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedExtrapleural pneumonectomy (EPP) and Cisplatin

Plus 4 other study approaches.

Who it may be forMesothelioma · Early-stage or resectable

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jan 23, 2017 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Brigham and Women's Hospital

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1
Sponsor: Brigham and Women's Hospital
Interventions being studied: Procedure: Extrapleural pneumonectomy (EPP); Drug: Cisplatin; Drug: gemcitabine; Drug: amifostine; Drug: sodium thiosulfate; Procedure: Pleurectomy/Decortication

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How this study is categorized

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

Cancer type

Mesothelioma→

Disease setting

Early-stage or resectable→

Treatment approach

Chemotherapy→Surgery→

Public criteria

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.

Requirements people may need to meetInclusion criteria

Histologically-proven diagnosis of stages I to III malignant mesothelioma of the pleura and negative mediastinal N2 lymph nodes (Malignancy is confined to the affected hemithorax)
Adequate organ function including the following: adequate cardiac function, pulmonary function, renal and hepatic function and bone marrow reserve
Adequate overall physical activity
Surgical candidate for cytoreductive surgery

Reasons someone may not be able to joinExclusion criteria

Extended disease outside the ipsilateral hemithorax as proven histologically, radiologically and/or intraoperatively
Have received chemotherapy and or radiation therapy within the last 3 years at the time of study entry
Serious concomitant systemic disorders
Second active primary malignancy (to exclude non- melanoma skin cancer)
Pregnancy at the time of the operation
Psychiatric or addictive disorder which would preclude obtaining informed consent

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Brigham and Women's HospitalBoston, Massachusetts

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 23, 2017. Always confirm current availability with the study team.

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