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

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alabama at Birmingham
• Collaborator: Novartis Pharmaceuticals
• Treatments: Diphosphonates; Zoledronic Acid

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.