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Pilot Study of Bisphosphonate Therapy (Zoledronic Acid) in Patients With Malignant Mesothelioma (UAB 0901) (UAB0901)

Primary Purpose

Mesothelioma

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Zometa

About this trial

This is an interventional treatment trial for Mesothelioma focused on measuring mesothelioma, zoledronic acid, zometa, bisphosphonate therapy, CT scan, PET scan

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Zometa

Arm 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.

Outcomes

Primary Outcome Measures

Tumor Response Rate Following Zoledronic Acid (Zometa)

The modified Response Evaluation Criteria in Solid Tumors Criteria (RECIST 2004) will be used for target lesions and assessed by CT scans. Complete Response (CR) is the disappearance of target lesions; Partial Response (PR) is greater than or equal to 30% reduction in the total tumor measurement; Stable Disease (SD) is the absence of response or progression; and Progressive Disease (PD) is a 20% increase in the total tumor measurement over nadir value or the appearance of new lesions.

Secondary Outcome Measures

Progression Free Survival (PFS)

Progression Free Survival is defined as the number of days from the day the subject started treatment to the day the subject experienced evidence of disease progression, as determined by radiological or clinical progression.

Overall Survival (OS)

Overall Survival is defined as the number of days from the day the subject started treatment to the day the subject experienced death or lost to follow-up.

Full Information

NCT ID

NCT01204203

First Posted

September 15, 2010

Last Updated

April 24, 2017

Sponsor

University of Alabama at Birmingham

Collaborators

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01204203

Brief Title

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

Acronym

UAB0901

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

June 2009 (undefined)

Primary Completion Date

April 2015 (Actual)

Study Completion Date

April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Alabama at Birmingham

Collaborators

Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mesothelioma

Keywords

mesothelioma, zoledronic acid, zometa, bisphosphonate therapy, CT scan, PET scan

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Zometa

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Zometa

Other Intervention Name(s)

Zoledronic acid

Intervention Description

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.

Primary Outcome Measure Information:

Title

Tumor Response Rate Following Zoledronic Acid (Zometa)

Description

Time Frame

Baseline up to 28 months or until progressive disease or death

Secondary Outcome Measure Information:

Title

Progression Free Survival (PFS)

Description

Time Frame

Baseline up to 28 months

Title

Overall Survival (OS)

Description

Overall Survival is defined as the number of days from the day the subject started treatment to the day the subject experienced death or lost to follow-up.

Time Frame

Baseline up to 28 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

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: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Francisco Robert, M.D.

Organizational Affiliation

University of Alabama at Birmingham

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Alabama at Birmingham

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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