Status:
COMPLETED
Study of Capecitabine to Treat Recurrent High Grade Gliomas
Lead Sponsor:
University of Florida
Conditions:
Malignant Glioma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine if capecitabine is effective in the treatment of high grade gliomas that have returned after completing treatment.
Detailed Description
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 g...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00717197
Start Date
July 1 2008
End Date
May 1 2013
Last Update
July 2 2013
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32610