Extrapleural Pneumonectomy With Intraoperative Intrathoracic/Intraperitoneal Heated Cisplatin With Amifostine and Sodium Thiosulfate

NCT00165516 | Completed Phase 2 DMC

• 1 other identifier: 03-302
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 2

Brief Summary

The purposes of this study are: to evaluate the effects (good and bad) that administering heated cisplatin into the chest and abdomen cavity following surgical resection has on malignant mesothelioma; to collect data on the toxicity of cisplatin given directly into the chest and abdomen, and the levels of the cisplatin in the body; to determine if this treatment method has the possibility of helping patients with pleural mesothelioma live longer; and to determine if this treatment method can help decrease the rate of local recurrence of mesothelioma.

Conditions

Pleural Mesothelioma; Malignant Pleural Mesothelioma

Keywords

Extrapleural pneumonectomy; cisplatin; heated cisplatin

Outcome Measures

Primary Outcomes (1)

• To monitor tumor recurrence and patient survival, and compare those results to historic controls.

Secondary Outcomes (2)

• To document the morbidity and mortality of this treatment protocol in this patient population

  3 years

• to evaluate the pharmacokinetics of cisplatin.

  3 years

Interventions

Cisplatin DRUG

Heated and given as an one-hour lavage of the chest and abdomen during surgery

Sodium Thiosulfate DRUG

After the one-hour lavage, sodium thiosulfate is given intravenously

Eligibility Criteria

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

You may qualify if:

• Male of non-pregnant female 18 years of age or older
• HIstopathologic confirmation of malignant pleural mesothelioma
• Ejection fraction \> 45%
• Evidence of adequate renal and hepatic function
• Grossly normal contralateral pulmonary function with a chest radiograph and chest CT scan that do not show acute infiltrates
• FEV1 \> or = to 2.0L on a preoperative pulmonary function test
• Karnofsky performance status of 70% or greater

You may not qualify if:

• Extended disease outside the ipsilateral hemithorax as determined by pre-operative radiographs or intraoperative findings
• Positive extrapleural nodes as determined by mediastinoscopy
• Positive LENIs
• Gross disease present within the hemithorax after surgery
• Evidence of distant metastases
• Severe non-malignant co-morbid disease: uncontrolled angina, myocardial infarction in the past 6 months, renal insufficiency, liver disease, pulmonary hypertension
• Presence of active concomitant malignancy
• Patients with a psychiatric or addictive disorder which would preclude informed consent
• Previous chemotherapy or radiation therapy to treat mesothelioma
• Chemotherapy or radiation therapy administered within 3 years for another 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 2
• 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: January 1, 2004
• Primary Completion: July 1, 2006
• Study Completion: December 1, 2009
• Last Updated: March 27, 2014

Record last verified: 2014-03

Locations

US (2)