Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00165516
Status:
COMPLETED
Last Update Posted:
2014-03-27
First Post:
2005-09-12
Brief Title:
Extrapleural Pneumonectomy With Intraoperative IntrathoracicIntraperitoneal Heated Cisplatin With Amifostine and Sodium Thiosulfate
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase II Feasibility Study of Extrapleural Pneumonectomy With Intraoperative IntrathoracicIntraperitoneal Heated Cisplatin With Amifostine and Sodium Thiosulfate
Status:
COMPLETED
Status Verified Date:
2014-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None