Status:
COMPLETED
Pilot Study of Bisphosphonate Therapy (Zoledronic Acid) in Patients With Malignant Mesothelioma (UAB 0901)
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
Novartis Pharmaceuticals
Conditions:
Mesothelioma
Eligibility:
All Genders
19+ years
Phase:
PHASE2
Brief Summary
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 res...
Detailed Description
This pilot study will examine the effect of bisphosphonate (zoledronic acid) in patients with malignant mesothelioma. Evaluation will be limited to patients with standard (CT scans) and functional ins...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01204203
Start Date
June 1 2009
End Date
April 1 2016
Last Update
May 24 2017
Active Locations (1)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294