Pilot Study of Bisphosphonate Therapy (Zoledronic Acid) in Patients With Malignant Mesothelioma (UAB 0901)

Completed · Phase 2

Conditions studied: Mesothelioma

In brief

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.

Key facts

Study ID

NCT01204203

Run by

University of Alabama at Birmingham

People needed

8

Starts

2009-06-01

Expected to finish

2016-04-01

Last updated by the study team

2017-05-24

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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