Know Cancer

forgot password

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

Phase 2
19 Years
Open (Enrolling)

Thank you

Trial Information

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

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.

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

- Breastfeeding, pregnant, or likely to become pregnant during the clinical trial.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluation of the tumor response rate following zoledronic acid

Outcome Description:

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.

Outcome Time Frame:

CT and/or PET scans will be performed to measure tumor size approximately every 56 days until there is tumor growth

Safety Issue:


Principal Investigator

Francisco Robert, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Alabama at Birmingham


United States: Food and Drug Administration

Study ID:

F090917002 (UAB 0901)



Start Date:

June 2009

Completion Date:

November 2014

Related Keywords:

  • Mesothelioma
  • mesothelioma
  • zoledronic acid
  • zometa
  • bisphosphonate therapy
  • CT scan
  • PET scan
  • Mesothelioma



University of Alabama at Birmingham Birmingham, Alabama  35294-3300