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A Phase I Trial of Extrapleural Pneumonectomy/Pleurectomy Decortication, Intrathoracic/Intraperitoneal Hyperthermic (IOHC) Cisplatin and Gemcitabine With Intravenous Amifostine and Sodium Thiosulfate Cytoprotection for Patients With Resectable Malignant Pleural Mesothelioma


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Malignant Pleural Mesothelioma

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Trial Information

A Phase I Trial of Extrapleural Pneumonectomy/Pleurectomy Decortication, Intrathoracic/Intraperitoneal Hyperthermic (IOHC) Cisplatin and Gemcitabine With Intravenous Amifostine and Sodium Thiosulfate Cytoprotection for Patients With Resectable Malignant Pleural Mesothelioma


- This is a dose escalation study of gemcitabine with a fixed dose of cisplatin

- Patients will undergo cytoreductive surgery, which entails the removal of the inner and
outer lining of the lung (pleurectomy/decortication) with or without the lung itself
(extrapleural pneumonectomy), including the lining overlying the pericardium and
diaphragm. Resection of the pericardium and diaphragm are occasionally necessary to
remove all visable tumor. This surgery is part of standard care for malignant pleural
mesothelioma.

- After surgery, a one hour lavage with heated cisplatin and or gemcitabine will be
administered to the hemithorax (and abdominal regions if the diaphragm is no longer
present).

- Patients will remain hospitalized until they have recovered from surgery (usually 7-14
days).

- Patients will return to the hospital during the first month after their surgery to be
evaluated by the medical staff.

- Dose escalation: 1) Three patients will be treated at the first dose level of
gemcitabine. Labs will be monitored on a weekly basis, including a CBC, Chem-7, and
LFT's. In the absence of developing dose-limiting toxicity (DLT) among the first 3
patients treated, dosages can be escalated. DLT will be defined as any grade 3 or
higher renal toxicity, thrombocytopenia or other grade 3 toxicity not related to
surgery 2) If none of these 3 patients have any toxicity, we will proceed to the next
level of gemcitabine. 3) If DLT occurs in 1 of 3 patients at a given dose level, then
3 additional patients are added at that dose (for a total of 6 at this level)If no DLT
occurs, we will proceed to the next level of gemcitabine. If DLT occurs in another
patient, this dose is considered the maximum tolerated dose (MTD). 4) At any dose, 3
cases of DLT lead to discontinuation of recruitment at that dose and enrollment of 3
additional patients at a lower dose.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To establish the maximally tolerated dose (MTD) of intraoperative Intrathoracic/Intraperitoneal hyperthermic gemcitabine and cisplatin combination modulated by amifostine and sodium thiosulfate in patients with malignant pleural mesothelioma.

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

David J Sugarbaker, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Brigham and Women's Hospital

Authority:

United States: Institutional Review Board

Study ID:

07-091

NCT ID:

NCT00571298

Start Date:

November 2007

Completion Date:

May 2014

Related Keywords:

  • Malignant Pleural Mesothelioma
  • Extrapleural pneumonectomy
  • Pleurectomy Decortication
  • Mesothelioma
  • cisplatin
  • gemcitabine
  • amifostine
  • sodium thiosulfate
  • Mesothelioma

Name

Location

Brigham and Women's HospitalBoston, Massachusetts  02115