Extrapleural Pneumonectomy With Intraoperative Intrathoracic/Intraperitoneal Heated Cisplatin With Amifostine and Sodium Thiosulfate - Full Text View

Sponsor:	Dana-Farber Cancer Institute
Collaborator:	Brigham and Women's Hospital
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00165516

Purpose

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.

Condition	Intervention	Phase
Pleural Mesothelioma Malignant Pleural Mesothelioma	Drug: Cisplatin Drug: Sodium Thiosulfate	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II Feasibility Study of Extrapleural Pneumonectomy With Intraoperative Intrathoracic/Intraperitoneal Heated Cisplatin With Amifostine and Sodium Thiosulfate

Resource links provided by NLM:

MedlinePlus related topics: Cancer Mesothelioma

Drug Information available for: Sodium thiosulfate Cisplatin Amifostine Sodium hyposulfite

U.S. FDA Resources

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

To monitor tumor recurrence and patient survival, and compare those results to historic controls. [ Time Frame: TBD ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To document the morbidity and mortality of this treatment protocol in this patient population [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
to evaluate the pharmacokinetics of cisplatin. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment:	85
Study Start Date:	January 2004
Estimated Study Completion Date:	January 2010
Primary Completion Date:	July 2006 (Final data collection date for primary outcome measure)

Intervention Details:

Heated and given as an one-hour lavage of the chest and abdomen during surgery

After the one-hour lavage, sodium thiosulfate is given intravenoulsy.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male of non-pregnant female 18 years of age or older
HIstopathologic confirmation of malignant pleural mesothelioma
Ejection fraction > 45%
Evidence of adequate renal and hepatic function
Grossly normal contralateral pulmonary function with a chest radiograph and chest CT scan that do not show acute infiltrates
FEV1 > or = to 2.0L on a preoperative pulmonary function test
Karnofsky performance status of 70% or greater

Exclusion Criteria:

Extended disease outside the ipsilateral hemithorax as determined by pre-operative radiographs or intraoperative findings
Positive extrapleural nodes as determined by mediastinoscopy
Positive LENIs
Gross disease present within the hemithorax after surgery
Evidence of distant metastases
Severe non-malignant co-morbid disease: uncontrolled angina, myocardial infarction in the past 6 months, renal insufficiency, liver disease, pulmonary hypertension
Presence of active concomitant malignancy
Patients with a psychiatric or addictive disorder which would preclude informed consent
Previous chemotherapy or radiation therapy to treat mesothelioma
Chemotherapy or radiation therapy administered within 3 years for another malignancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00165516

Locations

United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Dana-Farber Cancer Institute

Brigham and Women's Hospital

Investigators

Principal Investigator:

David J. Sugarbaker, MD

Brigham and Women's Hospital

More Information

No publications provided

Responsible Party:	Brigham and Women's Hospital ( David J. Sugarbaker, MD )
Study ID Numbers:	03-302
Study First Received:	September 12, 2005
Last Updated:	December 15, 2009
ClinicalTrials.gov Identifier:	NCT00165516 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:

Extrapleural pneumonectomy
cisplatin
heated cisplatin

Additional relevant MeSH terms:

Anti-Infective Agents
Radiation-Protective Agents
Antioxidants
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Amifostine
Neoplasms, Mesothelial
Antineoplastic Agents
Physiological Effects of Drugs
Sodium thiosulfate
Protective Agents
Pharmacologic Actions

Anti-Bacterial Agents
Neoplasms
Cisplatin
Radiation-Sensitizing Agents
Therapeutic Uses
Mesothelioma
Chelating Agents
Antitubercular Agents
Adenoma
Antidotes
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on February 08, 2010