NCT00165516

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Pleural Mesothelioma
• Malignant Pleural Mesothelioma

Interventions

Type	Name	Description
DRUG	Cisplatin	Heated and given as an one-hour lavage of the chest and abdomen during surgery
DRUG	Sodium Thiosulfate	After the one-hour lavage, sodium thiosulfate is given intravenously

Timeline

• Start date: 2004-01-01
• Primary completion: 2006-07-01
• Completion: 2009-12-01
• First posted: 2005-09-14
• Last updated: 2014-03-27

Locations

2 sites across 1 country: United States