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

Mesothelioma Clinical Trial

— UAB 0901  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01204203
• Other study ID #: F090917002 (UAB 0901)
• Secondary ID: UAB 0901
• Status: Completed
• Phase: Phase 2
• First received: September 15, 2010
• Last updated: May 20, 2016
• Start date: June 2009
• Est. completion date: April 2016

Study information

• Verified date: May 2016
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: April 2016
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Mesothelioma

Intervention

Drug:
• Zometa
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.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the tumor response rate following zoledronic acid	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.	CT and/or PET scans will be performed to measure tumor size approximately every 56 days until there is tumor growth	Yes
Secondary	Evaluation of the duration of tumor response	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.	Assessments approximately every 8 weeks for the patient's life	No