MedTrace Logo

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

NCT00571298 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 141

Last updated 2017-01-23

No results posted yet for this 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.

Conditions

  • Malignant Pleural Mesothelioma

Interventions

PROCEDURE

Extrapleural pneumonectomy (EPP)

Resection of the lung, the lining of the lung (pleura), the covering of the heart (pericardium), and the muscle that separates the chest and abdomen (diaphragm)

DRUG

Cisplatin

Given after the tumor is removed as a bath (perfusion) for one-hour

DRUG

gemcitabine

Given after the tumor is removed as a bath (perfusion) for one-hour

DRUG

amifostine

Given intravenously before perfusion chemotherapy and then 2 hours after the first dose

DRUG

sodium thiosulfate

Given intravenously immediately at the end of perfusion chemotherapy

PROCEDURE

Pleurectomy/Decortication

Resection of the lining of the lung (pleura), while the lung remains intact.

Sponsors & Collaborators

Principal Investigators

  • Raphael Bueno, MD · Brigham and Women's Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2011-11-30
Completion
2015-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00571298 on ClinicalTrials.gov