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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University of Alabama at Birmingham
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Francisco Robert,MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01204203
First received: September 15, 2010
Last updated: August 26, 2014
Last verified: August 2014
  Purpose

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
Mesothelioma
Drug: Zometa (zoledronic acid)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 12
Study Start Date: June 2009
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: infusion of zoledronic acid
Zoledronic acid will be administered 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)
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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01204203

Contacts
Contact: Mary L. Jerome, RN 205-934-5092 msjerome@uab.edu
Contact: Liz A. Busby, RN, BSN, OCN 205-934-0337 busbyrn@uab.edu

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Mary L. Jerome, RN    205-934-5092    msjerome@uab.edu   
Contact: Liz A. Busby, RN, BSN, OCN    205-934-0337    busbyrn@uab.edu   
Principal Investigator: Francisco Robert, M.D.         
Sponsors and Collaborators
University of Alabama at Birmingham
Novartis Pharmaceuticals
Investigators
Principal Investigator: Francisco Robert, M.D. University of Alabama at Birmingham
  More Information

No publications provided

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
Study First Received: September 15, 2010
Last Updated: August 26, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Mesothelioma
Neoplasms, Mesothelial
Lung Neoplasms
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014