Study of Capecitabine to Treat Recurrent High Grade Gliomas

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Florida
• Treatments: Capecitabine

Criteria

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