Pilot Study to Determine Therapeutic Response of Oral Capecitabine (Xeloda) in Recurrent High Grade Gliomas (HGGs) by Establishing the Radiographic Response Rate Using Modified Macdonald Criteria
High grade gliomas (HGGs) represent a heterogenous group of primary brain tumors that share
WHO grade III or IV classification (anaplastic astrocytoma, anaplastic oligodendroglioma,
anaplastic mixed glioma, and glioblastoma multiforme). Despite the upfront use of surgery,
radiation, and chemotherapy, high grade gliomas uniformly result in recurrence and death.
Palliative chemotherapy offers an improvement in time to progression, symptom control,
quality of life, and potential survival; however, no established chemotherapy regimen for
recurrence exists and new treatments are needed. Oral capecitabine is a rationale strategy
for therapeutic palliation of recurrent high grade gliomas given its oral administration,
its well-known kinetics and toxicities, its non-competitive toxicities to other high grade
glioma treatments, its well established management algorithms, its established evidence of
entry into the central nervous system, and its evidence of safety and efficacy in
malignancies in the central nervous system.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Percentage of Participants With Progression-free Survival.
Gadolinium-contrasted MRIs were used to assess radiographic response every 2 cycles (~6 weeks). Tumor progression was defined by increasing tumor size, new areas of tumor, or unequivocal neurologic deterioration.
From date of first dose of study drug until month 6.
Erin Dunbar, MD
University of Florida
United States: Institutional Review Board
|University of Florida||Gainesville, Florida 32610-0277|