Clinical Trial Details

NCT ID: NCT01204203
Date Last Changed: February 22, 2015


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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Recruitment Details

Both Male and Female
19 and up
Overall Status
Lead Sponsor
University of Alabama at Birmingham
69 Months
Facility Type


Both Male and Female ages 19 Years and up

Inclusion Criteria:

  • 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 the trial.

  • Willing and able to provide written informed consent.

Exclusion Criteria:

  • 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 therapy.

  • Breastfeeding, pregnant, or likely to become pregnant during the clinical trial.

Site Locations (1)

Country State City Zip Facility and Contact
United States Alabama Birmingham 35294 University of Alabama at Birmingham
Mary L. Jerome, RN

Francisco Robert, M.D.
Principal Investigator


Mary L. Jerome, RN

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