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Pleurectomy/Decortication Followed by Intrathoracic/Intraperitoneal Heated Cisplatin for Malignant Pleural Mesothelioma

NCT00165555 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2014-03-27

No results posted yet for this study

Summary

The purpose of this study it to determine the safety and maximally tolerated dose (MTD) of 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.

Conditions

  • Pleural Mesothelioma
  • Malignant Pleural Mesothelioma

Interventions

DRUG

Cisplatin

Given as a heated one-hour lavage to the hemithorax after surgery.

DRUG

Sodium Thiosulfate

Given intravenously over 6 hours after the cisplatin lavage.

Sponsors & Collaborators

Principal Investigators

  • David J. Sugarbaker, MD · Brigham and Women's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-08-31
Primary Completion
2002-04-30
Completion
2009-11-30

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 NCT00165555 on ClinicalTrials.gov