A Pilot Phase 2 Study of Bisphosphonate Therapy (Zoledronic Acid) in Patients With Advanced Malignant Mesothelioma
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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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
Francisco Robert, M.D.
University of Alabama at Birmingham
United States: Food and Drug Administration
F090917002 (UAB 0901)
|University of Alabama at Birmingham||Birmingham, Alabama 35294-3300|