Pilot Study of Bisphosphonate Therapy (Zoledronic Acid) in Patients With Malignant Mesothelioma (UAB 0901) (UAB0901)
|ClinicalTrials.gov Identifier: NCT01204203|
Recruitment Status : Completed
First Posted : September 17, 2010
Results First Posted : May 24, 2017
Last Update Posted : May 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|Mesothelioma||Drug: Zometa||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Phase 2 Study of Bisphosphonate Therapy (Zoledronic Acid) in Patients With Advanced Malignant Mesothelioma|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||April 2016|
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.
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.
Other Name: Zoledronic acid
- Tumor Response Rate Following Zoledronic Acid (Zometa) [ Time Frame: Baseline up to 28 months or until progressive disease or death ]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.
- Progression Free Survival (PFS) [ Time Frame: Baseline up to 28 months ]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) [ Time Frame: Baseline up to 28 months ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01204203
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35294|
|Principal Investigator:||Francisco Robert, M.D.||University of Alabama at Birmingham|