Extrapleural Pneumonectomy /Pleurectomy Decortication, IHOC Cisplatin and Gemcitabine With Amifostine and Sodium Thiosulfate Cytoprotection for Resectable Malignant Pleural Mesothelioma

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: After removal of visible cancer in the chest, chemotherapy drugs are used to kill or stop tumor cells from dividing, so that they stop growing or/and die. Cisplatin is currently used safely as in intra-operative treatment for malignant pleural mesothelioma. This study is aimed to determine if the addition of gemcitabine as a second intracavitary chemotherapy can be accomplished safely.

PURPOSE: This is a Phase I trial to study the efficacy of combination chemotherapy consisting of gemcitabine and 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 and the effect of cytoprotection agents: amifostine and sodium thiosulfate to counteract potential side effects of chemotherapy.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Collaborator: Dana-Farber Cancer Institute
• Treatments: Amifostine; Cisplatin; Gemcitabine; Sodium thiosulfate

Criteria

Inclusion Criteria:

• Histologically-proven diagnosis of stages I to III malignant mesothelioma of the pleura and negative mediastinal N2 lymph nodes (Malignancy is confined to the affected hemithorax)

• Adequate organ function including the following: adequate cardiac function, pulmonary function, renal and hepatic function and bone marrow reserve

• Adequate overall physical activity

• Surgical candidate for cytoreductive surgery

Exclusion Criteria:

• Extended disease outside the ipsilateral hemithorax as proven histologically, radiologically and/or intraoperatively

• Have received chemotherapy and or radiation therapy within the last 3 years at the time of study entry

• Serious concomitant systemic disorders

• Second active primary malignancy (to exclude non- melanoma skin cancer)

• Pregnancy at the time of the operation

• Psychiatric or addictive disorder which would preclude obtaining informed consent