Clinical trial NCT00717197: Study of Capecitabine to Treat Recurrent High Grade Gliomas
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Malignant Glioma
Keywords: HGG
anaplastic astrocytoma
anaplastic oligodendroglioma
anaplastic mixed glioma
glioblastoma multiforme
GBM
Xeloda
capecitabine
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2008-07-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of Participants With Progression-free Survival.
timeFrame: From date of first dose of study drug until month 6.
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Erin Dunbar, MD
role: PRINCIPAL_INVESTIGATOR
References: