Clinical Trials for Mesothelioma Patients—A Study of Decitabine and FR901228: Patient Characteristics

Read about the patient characteristics for a current clinical trial about the use of Decitabine and FR901228 for patients with mesothelioma. Please note: this information is provided by Weitz & Luxenberg for informational purposes only.

Patient Characteristics:
Age:
18 and over
Performance status:
ECOG 0-2
Life expectancy:
At least 3 months
Hematopoietic:
Absolute neutrophil count at least 1,500/mm^3 (without cytokine support)
Platelet count greater than 100,000/mm^3 (without transfusion)
Hepatic:
Bilirubin less than 1.5 times upper limit of normal
PT normal
Renal:
Creatinine no greater than 1.6 mg/dL OR
Creatinine clearance greater than 70 mL/min
Cardiovascular:
LVEF less than 50% by MUGA scan or echocardiogram
No New York Heart Association class III or IV heart disease (i.e., decompensated heart failure)
No myocardial infarction within the past year
No uncontrolled arrhythmias
No prior serious ventricular arrhythmias not controlled by coronary artery bypass surgery
No prosthetic heart valves requiring anticoagulation
No deep venous thrombosis
No left ventricular hypertrophy
No history of sustained ventricular tachycardia, ventricular fibrillation, Torsades de Pointes, or cardiac arrest without currently having an automatic implantable cardioverter defibrillator in place
No congenital long QT syndrome or QTc > 480 msec
No Mobitz II second degree block without currently having a pacemaker in place
No cardiac arrhythmias requiring antiarrhytmic medication except a beta blocker or calcium channel blocker
No hypertrophic or restrictive cardiomyopathy from prior treatment of other causes
No uncontrolled hypertension (i.e., blood pressure =160/95)
No clinically significant active myocardial ischemia on the basis of nuclear imaging or angiography
No history of coronary artery disease (e.g., angina Canadian Class II-IV or positive stress imaging study)
No evidence of cardiac ischemia (e.g., ST depression greater than or equal to 2 mm) by EKG
First degree or Mobitz second degree block, bradyarrhythmias, or sick sinus syndrome allowed provided patient undergo Holter monitoring and cardiac evaluation

Pulmonary:
FEV_1 and DLCO greater than 30% predicted
Partial pressure of carbon dioxide (pCO_2) less than 50 mm Hg on room air
Partial pressure of oxygen (pO_2) greater than 60 mm Hg on room air
No pulmonary embolism

Other:
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No active infections
HIV negative

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