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
18 Years
N/A
Both
Malignant Glioma
Trial Information
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.
Inclusion Criteria:
- Histological confirmation of high grade glioma (WHO grade III or IV: anaplastic
astrocytoma, anaplastic oligodendroglioma, anaplastic mixed glioma, and glioblastoma
multiforme)
- Male or female 18 years of age or older
- Negative pregnancy test (if of childbearing potential)
- Any number of previous recurrences will be allowed
- Karnofsky Performance Status > 60
- Hematocrit > 30,000
- White blood cell count > 1,500
- Platelet > 100,000
- Absolute Neutrophil Count > 1,000
- Bilirubin < 1.5 x upper limits of normal
- Transaminases (ALT and AST) < 1.5 x upper limits of normal
- Creatinine < 1.5 x upper limits of normal
- Adequate medical health to participate in this study
- Adequate documentation of menopause (natural/surgical) or patient commitment to
routine use of reliable birth control (barrier/hormonal)
- Ability to read and understand the informed consent document
- Ability and willingness to follow all requirements of the study including following
all directions, taking medication as prescribed and completing all diaries and forms
Exclusion Criteria:
- Karnofsky Performance Status < 60
- Hematocrit < 30,000
- White blood cell count < 1,500
- Platelet < 100,000
- Absolute Neutrophil Count < 1,000
- Bilirubin >1.5 x upper limits of normal
- Transaminases (ALT and AST) > 1.5 x upper limits of normal
- Creatinine > 1.5 x upper limits of normal
- Inability to undergo gadolinium-contrasted MRIs, including severe claustrophobia or
insufficient allergy prophylaxis
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Percentage of Participants With Progression-free Survival.
Outcome Description:
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.
Outcome Time Frame:
From date of first dose of study drug until month 6.
Safety Issue:
No
Principal Investigator
Erin Dunbar, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Florida
Authority:
United States: Institutional Review Board
Study ID:
HGG-001
NCT ID:
NCT00717197
Start Date:
July 2008
Completion Date:
July 2013
Related Keywords:
- Malignant Glioma
- HGG
- anaplastic astrocytoma
- anaplastic oligodendroglioma
- anaplastic mixed glioma
- glioblastoma multiforme
- GBM
- Xeloda
- capecitabine
- Glioma
Name | Location |
|---|---|
| University of Florida | Gainesville, Florida 32610-0277 |
