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

NCT00165555 | Completed Phase 1 DMC

• 1 other identifier: 99-124
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

cisplatin; pleurectomy; decortication; heated cisplatin

Outcome Measures

Primary Outcomes (1)

• To determine the maximally tolerated dose of intracavitary cisplatin in patients with malignant pleural mesothelioma,

  3 years

Secondary Outcomes (2)

• To quantitate the safety of intraoperative intrathoracic/intraperitoneal hyperthermic cisplatin

  3 years

• to study the pharmacokinetics of cisplatin administered in this way.

  3 years

Interventions

Cisplatin DRUG

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

Sodium Thiosulfate DRUG

Given intravenously over 6 hours after the cisplatin lavage.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years of age or older
• Malignancy is confined to the affected hemithorax.
• Grossly normal cardiac function with an EKG showing no cardiomyopathy or acute changes
• Evidence of adequate renal and hepatic function
• Karnofsky performance status of 70% or greater

You may not qualify if:

• Extended disease outside the ipsilateral hemithorax as determined radiologically and intraoperatively
• Distant metastases
• Non-malignant systemic disease
• Active concomitant malignancy
• Psychiatric or addictive disorders which would preclude obtaining informed consent
• Prior treatment within the last 2 months, other than surgical resection for their current malignancy

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Brigham and Women's Hospital: collaborator

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Mesothelioma, Malignant

Interventions

Cisplatin; sodium thiosulfate

Condition Hierarchy (Ancestors)

Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• David J. Sugarbaker, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 14, 2005
• Study Start: August 1, 1999
• Primary Completion: April 1, 2002
• Study Completion: November 1, 2009
• Last Updated: March 27, 2014

Record last verified: 2014-03

Locations

US (2)