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

This study has been completed.
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Francisco Robert,MD, University of Alabama at Birmingham Identifier:
First received: September 15, 2010
Last updated: May 20, 2016
Last verified: May 2016
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.

Condition Intervention Phase
Drug: Zometa
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Phase 2 Study of Bisphosphonate Therapy (Zoledronic Acid) in Patients With Advanced Malignant Mesothelioma

Resource links provided by NLM:

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Evaluation of the tumor response rate following zoledronic acid [ Time Frame: CT and/or PET scans will be performed to measure tumor size approximately every 56 days until there is tumor growth ]
    The best objective response from either the modified RECIST (CT scan) or the Metabloic Response (PET scan) efficacy method of evaluation will be used to determine the first evaluation after 2 cycles of treatment. In subsequent evaluations for response, modified RECIST with CT scans will be the only instrument to evaluate the response to therapy.

Secondary Outcome Measures:
  • Evaluation of the duration of tumor response [ Time Frame: Assessments approximately every 8 weeks for the patient's life ]
    The patient's medical condition will be followed for the rest of their lives with continued CT scans being performed every 8 weeks to document tumor growth while off of the study medication.

Enrollment: 8
Study Start Date: June 2009
Study Completion Date: April 2016
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zometa
Zometa (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.
Drug: Zometa
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.
Other Name: Zoledronic acid

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 instruments (FDG PET Scans) of tumor assessment after the administration of standard doses of zoledronic acid (4 mg IV every 3 weeks). We will also explore the biologic effect of zoledronic acid in patients using new serum markers as well as several blood level markers.

Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01204203

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Novartis Pharmaceuticals
Principal Investigator: Francisco Robert, M.D. University of Alabama at Birmingham
  More Information

Responsible Party: Francisco Robert,MD, Professor, University of Alabama at Birmingham Identifier: NCT01204203     History of Changes
Other Study ID Numbers: F090917002 (UAB 0901)
UAB 0901 ( Other Grant/Funding Number: Novartis CZOL446EUS144T )
Study First Received: September 15, 2010
Last Updated: May 20, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by University of Alabama at Birmingham:
zoledronic acid
bisphosphonate therapy
CT scan
PET scan

Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Zoledronic acid
Bone Density Conservation Agents
Physiological Effects of Drugs processed this record on April 25, 2017