Study of Capecitabine to Treat Recurrent High Grade Gliomas

Completed · Phase 2

Conditions studied: Malignant Glioma

In brief

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.

Key facts

Study ID

NCT00717197

Run by

University of Florida

People needed

30

Starts

2008-07-01

Expected to finish

2013-05-01

Last updated by the study team

2013-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Florida — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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