Pilot Study of Bisphosphonate Therapy (Zoledronic Acid) in Patients With Malignant Mesothelioma (UAB 0901)
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Phase 2 Study of Bisphosphonate Therapy (Zoledronic Acid) in Patients With Advanced Malignant Mesothelioma|
- Evaluation of the tumor response rate following zoledronic acid [ Time Frame: CT and/or PET scans will be performed to measure tumor size approximately every 56 days until there is tumor growth ] [ Designated as safety issue: Yes ]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.
- Evaluation of the duration of tumor response [ Time Frame: Assessments approximately every 8 weeks for the patient's life ] [ Designated as safety issue: No ]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.
|Study Start Date:||June 2009|
|Estimated Study Completion Date:||April 2016|
|Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
Experimental: infusion of zoledronic acid
Zoledronic acid will be administered 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.
Drug: Zometa (zoledronic acid)
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|