Pilot Study of Bisphosphonate Therapy (Zoledronic Acid) in Patients With Malignant Mesothelioma (UAB 0901) (UAB0901)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01204203
Recruitment Status : Completed
First Posted : September 17, 2010
Results First Posted : May 24, 2017
Last Update Posted : May 24, 2017
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Francisco Robert,MD, University of Alabama at Birmingham

September 15, 2010
September 17, 2010
March 3, 2017
May 24, 2017
May 24, 2017
June 2009
April 2015   (Final data collection date for primary outcome measure)
Tumor Response Rate Following Zoledronic Acid (Zometa) [ Time Frame: Baseline up to 28 months or until progressive disease or death ]
The modified Response Evaluation Criteria in Solid Tumors Criteria (RECIST 2004) will be used for target lesions and assessed by CT scans. Complete Response (CR) is the disappearance of target lesions; Partial Response (PR) is greater than or equal to 30% reduction in the total tumor measurement; Stable Disease (SD) is the absence of response or progression; and Progressive Disease (PD) is a 20% increase in the total tumor measurement over nadir value or the appearance of new lesions.
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.
Complete list of historical versions of study NCT01204203 on Archive Site
  • Progression Free Survival (PFS) [ Time Frame: Baseline up to 28 months ]
    Progression Free Survival is defined as the number of days from the day the subject started treatment to the day the subject experienced evidence of disease progression, as determined by radiological or clinical progression.
  • Overall Survival (OS) [ Time Frame: Baseline up to 28 months ]
    Overall Survival is defined as the number of days from the day the subject started treatment to the day the subject experienced death or lost to follow-up.
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.
Not Provided
Not Provided
Pilot Study of Bisphosphonate Therapy (Zoledronic Acid) in Patients With Malignant Mesothelioma (UAB 0901)
A Pilot Phase 2 Study of Bisphosphonate Therapy (Zoledronic Acid) in Patients With Advanced Malignant Mesothelioma
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.
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.
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
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.
Intervention: Drug: Zometa
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
April 2016
April 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
19 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
F090917002 (UAB 0901)
UAB 0901 ( Other Grant/Funding Number: Novartis CZOL446EUS144T )
Not Provided
Plan to Share IPD: No
Francisco Robert,MD, University of Alabama at Birmingham
University of Alabama at Birmingham
Novartis Pharmaceuticals
Principal Investigator: Francisco Robert, M.D. University of Alabama at Birmingham
University of Alabama at Birmingham
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP