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

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:

  1. ANC ≥ 1.5 x 109/L
  2. Platelet Count ≥ 100 x 109/L
  3. Hemoglobin ≥ 9g/dL
  4. Serum bilirubin ≤ 1.5 x upper limit of normal (ULN)
  5. AST ≤ 2.5 x ULN
  6. ALT ≤ 2.5 x ULN
  7. ALK-P ≤ 3 x ULN
  8. Serum creatinine ≤ 1.8mg/dL
  9. 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.