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

Malignant Pleural Mesothelioma Clinical Trial

Official title:

A Phase II Feasibility Study of Extrapleural Pneumonectomy With Intraoperative Intrathoracic/Intraperitoneal Heated Cisplatin With Amifostine and Sodium Thiosulfate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00165516
• Other study ID #: 03-302
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: March 26, 2014
• Start date: January 2004
• Est. completion date: December 2009

Study information

• Verified date: March 2014
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

• Patients will undergo surgery called extrapleural pneumonectomy which involves removal of the lung, the lining of the lung, the covering of the heart, and the muscle that separates the chest and abdomen. At the conclusion of the resection, if the patient has less then 1 cm3 of residual gross disease in one or more areas, then the heated chemotherapy lavage will begin. If more than this volume of disease is present, then the patient will receive additional treatment off-study.

• The chemotherapy treatment consists of a one-hour lavage of the chest and abdomen cavity with heated cisplatin given in the operating room through the surgical incision. At the completion of the hour, sodium thiosulfate is given intravenously to reduce the potential side effects of cisplatin.

• During the surgery and for four hours following the completion of the cisplatin lavage, blood samples, urine samples, chest wall muscle samples, and samples of the chemotherapy solution will be done in order to measure the concentration of chemotherapy and the impact of cisplatin on the various cell samples.

• Patients will remain in the hospital until they have recovered from surgery (7-14 days). Following discharge from the hospital, patients will be seen 1-2 weeks post-operatively for blood tests. 6 weeks later additional blood tests and and echocardiogram will be performed. This echocardiogram will be repeated 6 months post-operatively to re-assess heart function.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: December 2009
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malignant Pleural Mesothelioma
• Mesothelioma
• Pleural Mesothelioma

Intervention

Drug:
• Cisplatin
Heated and given as an one-hour lavage of the chest and abdomen during surgery
• Sodium Thiosulfate
After the one-hour lavage, sodium thiosulfate is given intravenously

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To monitor tumor recurrence and patient survival, and compare those results to historic controls.		TBD	No
Secondary	To document the morbidity and mortality of this treatment protocol in this patient population		3 years	Yes
Secondary	to evaluate the pharmacokinetics of cisplatin.		3 years	No