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

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ClinicalTrials.gov Identifier: NCT01204203
Recruitment Status : Completed
First Posted : September 17, 2010
Results First Posted : May 24, 2017
Last Update Posted : May 24, 2017
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Francisco Robert,MD, University of Alabama at Birmingham

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Mesothelioma Drug: Zometa Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Phase 2 Study of Bisphosphonate Therapy (Zoledronic Acid) in Patients With Advanced Malignant Mesothelioma
Study Start Date : June 2009
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01204203


Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Novartis Pharmaceuticals
Investigators
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Principal Investigator: Francisco Robert, M.D. University of Alabama at Birmingham
More Information
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Responsible Party: Francisco Robert,MD, Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01204203    
Other Study ID Numbers: F090917002 (UAB 0901)
UAB 0901 ( Other Grant/Funding Number: Novartis CZOL446EUS144T )
First Posted: September 17, 2010    Key Record Dates
Results First Posted: May 24, 2017
Last Update Posted: May 24, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Francisco Robert,MD, University of Alabama at Birmingham:
mesothelioma
zoledronic acid
zometa
 bisphosphonate therapy
CT scan
PET scan
Additional relevant MeSH terms:
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Mesothelioma
Mesothelioma, Malignant
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Lung Neoplasms
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Neoplasms by Site
Pleural Neoplasms
Lung Diseases
Respiratory Tract Diseases
Zoledronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs