Skip Navigation

Advertise|Press|Contact|FAQ|CWConnect

Bookmark/Print/Share

Home » Clinical Trials » Mesothelioma

Clinical Trial Details

Overview

Research Study Summary

A Phase 2 clinical study for patients with Mesothelioma

Research Study Title

A Pilot Phase 2 Study of Bisphosphonate Therapy (Zoledronic Acid) in Patients With Advanced Malignant Mesothelioma

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.

To Learn more
Phase

2

Gender

Both Male and Female

Age

19 and up

Overall Status

Recruiting

Lead Sponsor

University of Alabama at Birmingham

Duration

65 Months

Facility Type

N/A

Eligibility

Both Male and Female ages 19 Years and up

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:

  • ANC ≥ 1.5 x 109/L

  • Platelet Count ≥ 100 x 109/L

  • Hemoglobin ≥ 9g/dL

  • Serum bilirubin ≤ 1.5 x upper limit of normal (ULN)

  • AST ≤ 2.5 x ULN

  • ALT ≤ 2.5 x ULN

  • ALK-P ≤ 3 x ULN

  • Serum creatinine ≤ 1.8mg/dL

  • 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.

Site Locations (1)

Country State City Zip Facility and Contact
United States Alabama Birmingham 35294 University of Alabama at Birmingham
Mary L. Jerome, RN
205-934-5092
msjerome@uab.edu

Francisco Robert, M.D.
Principal Investigator

Contact

Mary L. Jerome, RN
205-934-5092

If you would like to learn more about participating in this research study, please email the trial contact using the form below.

Name:
Address:
City:
State:
Zip/Postal Code:
Country:
Phone:
Email:  
Message:
 
Please leave this field empty.

NCT ID: NCT01204203

Date Last Changed: August 26, 2014

DISCLAIMER: This site is run by CenterWatch, a publishing company that focuses on the clinical trials industry. The information provided in this service is designed to help patients find clinical trials that may be of interest to them, and to help patients contact the centers conducting the research. CenterWatch is neither promoting this research nor involved in conducting any of these trials. Some study summaries have been edited for clarity purposes to make them easier to understand. View more study details here.