Pilot Study of Bisphosphonate Therapy (Zoledronic Acid) in Patients With Malignant Mesothelioma (UAB 0901)
Information source: University of Alabama at Birmingham
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Mesothelioma
Intervention: Zometa (zoledronic acid) (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: University of Alabama at Birmingham Official(s) and/or principal investigator(s): Francisco Robert, M.D., Principal Investigator, Affiliation: University of Alabama at Birmingham
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.
Clinical Details
Official title: A Pilot Phase 2 Study of Bisphosphonate Therapy (Zoledronic Acid) in Patients With Advanced Malignant Mesothelioma
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Evaluation of the tumor response rate following zoledronic acid
Secondary outcome: Evaluation of the duration of tumor response
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
Minimum age: 19 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
University of Alabama at Birmingham, Birmingham, Alabama 35294, United States
Additional Information
Starting date: June 2009
Last updated: May 6, 2015
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