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

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ClinicalTrials.gov Identifier: NCT01204203
Recruitment Status : Completed
First Posted : September 17, 2010
Results First Posted : May 24, 2017
Last Update Posted : May 24, 2017
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Francisco Robert,MD, University of Alabama at Birmingham

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Mesothelioma
Intervention Drug: Zometa
Enrollment 8
Recruitment Details Inclusion criteria included: adult patients (age>18) with unresectable Malignant Pleural Mesothelioma (MPM) who had progressed after one or more prior systemic therapies, had not received prior systemic therapy due to poor performance status (PS), and/or were unwilling to receive systemic chemotherapy.
Pre-assignment Details The primary objective of this study was to evaluate the anti-tumor activity of zoledronic acid (Zometa) in subjects with unresectable, advanced Malignant Pleural Mesothelioma (MPM).
Arm/Group Title Zoledronic Acid (Zometa)
Hide Arm/Group Description

Zoledronic acid (Zometa) 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.

Zoledronic acid (Zometa) 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.

Period Title: Overall Study
Started 8
Completed 8
Not Completed 0
Arm/Group Title Zoledronic Acid (Zometa)
Hide Arm/Group Description Zometa (zoledronic acid) 4mg 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.
Overall Number of Baseline Participants 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 8 participants
62
(49 to 77)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
0
   0.0%
Male
8
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants
8
1.Primary Outcome
Title Tumor Response Rate Following Zoledronic Acid (Zometa)
Hide Description 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.
Time Frame Baseline up to 28 months or until progressive disease or death
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with advanced malignant pleural mesothelioma.
Arm/Group Title Zometa
Hide Arm/Group 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.

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.

Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: percentage of responders
12.5
2.Secondary Outcome
Title Progression Free Survival (PFS)
Hide Description 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.
Time Frame Baseline up to 28 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with advanced malignant pleural mesothelioma.
Arm/Group Title Zometa
Hide Arm/Group 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.

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.

Overall Number of Participants Analyzed 8
Median (Full Range)
Unit of Measure: Months
2
(0.5 to 21)
3.Secondary Outcome
Title Overall Survival (OS)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with advanced malignant pleural mesothelioma.
Arm/Group Title Zometa
Hide Arm/Group 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.

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.

Overall Number of Participants Analyzed 8
Median (Full Range)
Unit of Measure: months
7
(0.8 to 28)
Time Frame From baseline to 28 months
Adverse Event Reporting Description Subjects with either stable disease or objective response continued treatment until disease progression and/or intolerable toxicity at which patients were taken off study. Subjects were monitored for toxicity using NCI CTAE v3.0 Criteria. Dose adjustment was allowed per standard guidelines for zoledronic acid for decreased creatinine clearance. Patients who completed at least one treatment cycle were included in data analysis.
 
Arm/Group Title Zoledronic Acid (Zometa)
Hide Arm/Group Description Zoledronic acid (Zometa) will be administered IV-4mg by infusion on Day 1 of a 3-week cycle followed by tumor assessment from CT and/or PET scans every 2 cycles.The treatment will take about 30-60 minutes with the infusion lasting about 15 minutes.This will continue until progression of disease and/or intolerable toxicity.
All-Cause Mortality
Zoledronic Acid (Zometa)
Affected / at Risk (%)
Total   0/8 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Zoledronic Acid (Zometa)
Affected / at Risk (%)
Total   0/8 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Zoledronic Acid (Zometa)
Affected / at Risk (%)
Total   0/8 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Francisco Robert, MD
Organization: University of Alabama at Birmingham
Phone: 205-934-5077
Responsible Party: Francisco Robert,MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01204203     History of Changes
Other Study ID Numbers: F090917002 (UAB 0901)
UAB 0901 ( Other Grant/Funding Number: Novartis CZOL446EUS144T )
First Submitted: September 15, 2010
First Posted: September 17, 2010
Results First Submitted: March 3, 2017
Results First Posted: May 24, 2017
Last Update Posted: May 24, 2017