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

Brief Title

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

Official Title

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

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.
    

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 Phase

Phase 2

Study Type

Interventional

Primary Outcome

Tumor Response Rate Following Zoledronic Acid (Zometa)

Secondary Outcome

 Progression Free Survival (PFS)

Condition

Mesothelioma

Intervention

Zometa

Study Arms / Comparison Groups

 Zometa

Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

8

Start Date

June 2009

Completion Date

April 2016

Primary Completion Date

April 2015

Eligibility 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.
      

Gender

All

Ages

19 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Francisco Robert, M.D., , 

Location Countries

United States

Location Countries

United States

NCT ID

NCT01204203

Organization ID

F090917002 (UAB 0901)

Secondary IDs

UAB 0901

Responsible Party

Principal Investigator

Study Sponsor

University of Alabama at Birmingham

Collaborators

 Novartis Pharmaceuticals

Study Sponsor

Francisco Robert, M.D., Principal Investigator, University of Alabama at Birmingham

Verification Date

April 2017