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A Phase II Feasibility Study of Pleurectomy/Decortication With Intraoperative Intrathoracic/Intraperitoneal Heated Cisplatin With Sodium Thiosulfate Followed ny Adjuvant ALIMTA/Cisplatin
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Brigham and Women's Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Start Date
April 1, 2004
Primary Completion Date
July 1, 2010
Completion Date
July 1, 2010
Last Updated
September 9, 2016
16
ACTUAL participants
Cisplatin
DRUG
Sodium Thiosulfate
DRUG
ALIMTA
DRUG
Lead Sponsor
Dana-Farber Cancer Institute
Collaborators
NCT05538806
NCT05765084
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT03710876