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

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
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

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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Locations

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294

Sponsors and Collaborators

University of Alabama at Birmingham

Novartis Pharmaceuticals

Investigators

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 History of Changes
Other Study ID Numbers:	F090917002 (UAB 0901); UAB 0901 ( Other Grant/Funding Number: Novartis CZOL446EUS144T )
First Posted:	September 17, 2010
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:

Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms	Neoplasms, Mesothelial; Zoledronic acid; Diphosphonates; Bone Density Conservation Agents; Physiological Effects of Drugs