Ignite Creation Date:
2025-12-24 @ 7:46 PM
Ignite Modification Date:
2025-12-25 @ 5:23 PM
Study NCT ID:
NCT00165503
Status:
TERMINATED
Last Update Posted:
2016-09-09
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Pleurectomy/Decortication With Intraoperative Intrathoracic/Intraperitoneal Heated Cisplatin With Sodium Thiosulfate
Sponsor:
Dana-Farber Cancer Institute
Organization:
Study Overview
Official Title:
A Phase II Feasibility Study of Pleurectomy/Decortication With Intraoperative Intrathoracic/Intraperitoneal Heated Cisplatin With Sodium Thiosulfate Followed ny Adjuvant ALIMTA/Cisplatin
Status:
TERMINATED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
lack of acurral
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 determine the feasibility of administering adjuvant cisplatin plus ALIMTA to patients who undergo surgery with heated cisplatin during surgery; to determine the effects (good and bad) of this combined modality approach in patients with mesothelioma; to evaluate cisplatin effects by determining where it goes and how it is excreted in the body from the collection of tissues and cisplatin samples; to collect and analyze discarded samples of mesothelioma tumor during surgery to help determine the genetic make-up of the disease.
Detailed Description:
OBJECTIVES:
Primary
* To determine the feasibility of administering adjuvant cisplatin plus Alimta to patients undergoing surgery with hyperthermic cisplatin.
Secondary
* To determine the morbidity and mortality of this treatment protocol
* To determine time to tumor recurrence and patient survival
* To evaluate the pharmacokinetics of intraoperatively administered cisplatin
DETAILS:
* Patients will undergo surgery, which is part of the standard care for mesothelioma, by a procedure called pleurectomy/decortication. This involves removal of the lining of the lung and all visible disease. Resection of the lining of the heart and the muscle that separates the chest and abdomen is occasionally necessary.
* Mesothelioma samples will be taken during the surgery. These samples will be used in a laboratory study to better understand the genetic makeup of the mesothelioma and to improve our ability to diagnose this disease.
* After the conclusion of the surgery, if a patient has less than 1cm thickness of residual gross disease in one or more areas, then the patient will continue on this study. If more than this volume of tumor is present, then the patient will receive additional treatment off-study.
* Heated chemotherapy (cisplatin) will be given in the operating room immediately following surgery. This treatment consists of a one-hour lavage of the chest and abdominal cavity with heated cisplatin through the surgical incision. At the completion of the hour, sodium thiosulfate is given intravenously for 6 hours to reduce potential side effects.
* 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 taken in order to measure the concentration of chemotherapy and the impact of cisplatin in these samples.
* Patients will remain in the hospital until they have recovered from surgery (7-14 days). In addition to standard post-operative care, blood tests will be done on a daily basis. Following discharge from the hospital, patients will be seen 1-2 weeks post-operatively for additional blood work. An echocardiogram will be done 6 weeks and 6 months post-operatively to assess heart function.
* Chemotherapy treatment consists of ALIMTA plus cisplatin on Day 1 of every 21-day chemotherapy cycle. A total of 3 cycles will be given starting 6-10 weeks after surgery.
* Folic acid, vitamin B12 and dexamethasone will be given in addition to the chemotherapy to help reduce side effects of the chemotherapy drugs.
* Approximately 30 days after the last dose of ALIMTA plus cisplatin, a CT scan(s) and blood work will be performed. In addition, patients will get a CT scan(s) every 3 months for approximately 24 months from the completion of study treatment.
* Long term follow-up will consist of clinic visits every 3 months for 2 years, every 6 months for 2 years, and then once a year.
Primary
* To determine the feasibility of administering adjuvant cisplatin plus Alimta to patients undergoing surgery with hyperthermic cisplatin.
Secondary
* To determine the morbidity and mortality of this treatment protocol
* To determine time to tumor recurrence and patient survival
* To evaluate the pharmacokinetics of intraoperatively administered cisplatin
DETAILS:
* Patients will undergo surgery, which is part of the standard care for mesothelioma, by a procedure called pleurectomy/decortication. This involves removal of the lining of the lung and all visible disease. Resection of the lining of the heart and the muscle that separates the chest and abdomen is occasionally necessary.
* Mesothelioma samples will be taken during the surgery. These samples will be used in a laboratory study to better understand the genetic makeup of the mesothelioma and to improve our ability to diagnose this disease.
* After the conclusion of the surgery, if a patient has less than 1cm thickness of residual gross disease in one or more areas, then the patient will continue on this study. If more than this volume of tumor is present, then the patient will receive additional treatment off-study.
* Heated chemotherapy (cisplatin) will be given in the operating room immediately following surgery. This treatment consists of a one-hour lavage of the chest and abdominal cavity with heated cisplatin through the surgical incision. At the completion of the hour, sodium thiosulfate is given intravenously for 6 hours to reduce potential side effects.
* 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 taken in order to measure the concentration of chemotherapy and the impact of cisplatin in these samples.
* Patients will remain in the hospital until they have recovered from surgery (7-14 days). In addition to standard post-operative care, blood tests will be done on a daily basis. Following discharge from the hospital, patients will be seen 1-2 weeks post-operatively for additional blood work. An echocardiogram will be done 6 weeks and 6 months post-operatively to assess heart function.
* Chemotherapy treatment consists of ALIMTA plus cisplatin on Day 1 of every 21-day chemotherapy cycle. A total of 3 cycles will be given starting 6-10 weeks after surgery.
* Folic acid, vitamin B12 and dexamethasone will be given in addition to the chemotherapy to help reduce side effects of the chemotherapy drugs.
* Approximately 30 days after the last dose of ALIMTA plus cisplatin, a CT scan(s) and blood work will be performed. In addition, patients will get a CT scan(s) every 3 months for approximately 24 months from the completion of study treatment.
* Long term follow-up will consist of clinic visits every 3 months for 2 years, every 6 months for 2 years, and then once a year.
Study Oversight
Has Oversight DMC:
True
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?: