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Study of Capecitabine to Treat Recurrent High Grade Gliomas
This study is currently recruiting participants.
Verified by University of Florida, February 2009
First Received: July 15, 2008   Last Updated: February 6, 2009   History of Changes
Sponsored by: University of Florida
Information provided by: University of Florida
ClinicalTrials.gov Identifier: NCT00717197
  Purpose

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.


Condition Intervention Phase
High Grade Gliomas
Drug: Capecitabine
Phase II

Drug Information available for: Capecitabine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Determine therapeutic response of oral capecitabine in recurrent high grade gliomas by establishing the radiographic response rate using modified Macdonald criteria. [ Time Frame: 2.5 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate the longitudinal effect of oral capecitabine on traditional quality of life and performance status measurements. [ Time Frame: 2.5 Years ] [ Designated as safety issue: No ]
  • Evaluate the longitudinal tolerability of capecitabine using standardized toxicity criteria. [ Time Frame: 2.5 Years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: July 2008
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Capecitabine
    1,000-1,250 mg/m2 taken by mouth twice daily for 14 out of 21 consecutive days until progression or unacceptable toxicity.
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00717197

Contacts
Contact: Christine Keeling, BSN, OCN 352.273.7981 christine.keeling@neurosurgery.ufl.edu

Locations
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: Christine Keeling, BSN, OCN     352-273-7981     christine.keeling@neurosurgery.ufl.edu    
Principal Investigator: Erin M Dunbar, MD            
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Erin Dunbar, MD University of Florida
  More Information

No publications provided

Responsible Party: University of Florida ( Erin M. Dunbar, MD )
Study ID Numbers: HGG-001
Study First Received: July 15, 2008
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00717197     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
HGG
anaplastic astrocytoma
anaplastic oligodendroglioma
anaplastic mixed glioma
glioblastoma multiforme
GBM
Xeloda
capecitabine

Study placed in the following topic categories:
Antimetabolites
Neuroectodermal Tumors
Glioblastoma
Capecitabine
Astrocytoma
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Oligodendroglioma
Glioblastoma Multiforme
Glioma
Recurrence
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Antimetabolites
Capecitabine
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Neoplasms, Nerve Tissue
Pharmacologic Actions
Neuroectodermal Tumors
Neoplasms
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Glioma
Neoplasms, Neuroepithelial
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009