Study of Capecitabine to Treat Recurrent High Grade Gliomas

Phase 2

Completed

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 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Capecitabine	Capecitabine	Capecitabine (1,000-1,250 mg/m2) taken by mouth twice daily for 14 out of 21 consecutive days until progression or unacceptable toxicity.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Progression-free Survival.	From date of first dose of study drug until month 6.	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.

Secondary Outcome Measures