Pilot Study of Bisphosphonate Therapy (Zoledronic Acid) in Patients With Malignant Mesothelioma (UAB 0901)
Condition: Mesothelioma
MeSH terms: Mesothelioma; Mesothelioma, Malignant
Intervention: Zometa
Intervention description: Zoledronic acid will be administered IV on the first day of a 21 day cycle at a concentration of 4 mg. The treatment will take about 30-60 minutes with the infusion lasting about 15 minutes.
Intervention MeSH terms: Zoledronic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No
Keywords: mesothelioma; zoledronic acid; zometa; bisphosphonate therapy; CT scan; PET scan

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 response criteria for 18F-FDG PET scans.
    

Eligibility criteria:

        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.