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Clinical Trial Details
Research Study Summary
A Phase 2 clinical study for patients with Mesothelioma
Research Study Title
A Pilot Phase 2 Study of Bisphosphonate Therapy (Zoledronic Acid) in Patients With Advanced Malignant Mesothelioma
The primary objective of this trial is to determine the response rate of single agent
zoledronic acid using a composite of criteria including the EORTC modified RECIST criteria
and the EORTC tumor response criteria for 18F-FDG PET scans.
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Both Male and Female
Both Male and Female ages 19 Years and up
Males and females > 18 years of age
Life expectancy of at least 2 months
Histologically confirmed unresectable malignant pleural mesothelioma (MPM)
Measurable disease by CT Scan criteria and/or positive metabolic activity of 18F-FDG
PET Scan criteria at screening
ECOG Performance Status of 0-2
Laboratory and clinical results within 2 weeks prior to Day 1 must be as follows:
ANC ≥ 1.5 x 109/L
Platelet Count ≥ 100 x 109/L
Hemoglobin ≥ 9g/dL
Serum bilirubin ≤ 1.5 x upper limit of normal (ULN)
AST ≤ 2.5 x ULN
ALT ≤ 2.5 x ULN
ALK-P ≤ 3 x ULN
Serum creatinine ≤ 1.8mg/dL
Calculated Serum Creatinine Clearance 40 - > 60ml/min
Female subjects of childbearing potential and all male subjects must be surgically
sterile or consent to use a medically acceptable method of contraception throughout
Willing and able to provide written informed consent.
Known central nervous system (CNS) tumor involvement
Evidence of other active malignancy requiring treatment
Clinically significant heart disease (e.g., congestive heart failure of New York
Heart Association Class 3 or 4 angina not well controlled by medication, or
myocardial infarction within 6 months)
Known infection with HIV or hepatitis
Clinically significant arrhythmias demonstrated on electrocardiogram (ECG). Note:
subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal
supraventricular tachycardia (SVT) are eligible.
Active, serious systemic disease, including active bacterial or fungal infection.
Subjects undergoing invasive dental procedures, significant periodontal disease or
history of osteonecrosis of the jaw.
Treatment within 4 weeks of the start of the trial with other systemic anticancer
Breastfeeding, pregnant, or likely to become pregnant during the clinical trial.
Site Locations (1)
||University of Alabama at Birmingham
Mary L. Jerome, RN
Francisco Robert, M.D.
NCT ID: NCT01204203
Date Last Changed: August 26, 2014
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