Mesothelioma | Pilot Study of Bisphosphonate Therapy (Zoledronic Acid) in Patients With Malignant Mesothelioma (UAB 0901)
Mesothelioma research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:ZometaZoledronic 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.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
ZometaZometa (zoledronic acid) will be administered by infusion on Day 1 of a 3-week cycle followed by tumor assessment from CT and/or PET scans every 2 cycles. This will continue until progression of disease and/or intolerable toxicity.
Start Date: June 2009
Completed Date: April 2016
Phase: Phase 2
Primary Outcome: Tumor Response Rate Following Zoledronic Acid (Zometa)
Secondary Outcome: Progression Free Survival (PFS)
Study sponsors, principal investigator, and references
Principal Investigator: Francisco Robert, M.D.
Lead Sponsor: University of Alabama at Birmingham
Collaborator: Novartis Pharmaceuticals