Study of Capecitabine to Treat Recurrent High Grade Gliomas

Study Overview
=================
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.

Official Title
-----------------
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

Conditions
-----------------
Malignant Glioma

Intervention / Treatment
-----------------
* Drug: Capecitabine


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Capecitabine<br>Capecitabine (1,000-1,250 mg/m2) taken by mouth twice daily for 14 out of 21 consecutive days until progression or unacceptable toxicity. | Drug: Capecitabine<br>* 1,000-1,250 mg/m2 taken by mouth twice daily for 14 out of 21 consecutive days until progression or unacceptable toxicity.<br>* Other names: Xeloda;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Progression-free Survival. | 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. | From date of first dose of study drug until month 6. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HGG, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed glioma, glioblastoma multiforme, GBM, Xeloda, capecitabine