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Sponsored by: |
University of Florida |
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Information provided by: | University of Florida |
ClinicalTrials.gov Identifier: | NCT00717197 |
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 |
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High Grade Gliomas |
Drug: Capecitabine |
Phase II |
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 |
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) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Christine Keeling, BSN, OCN | 352.273.7981 | christine.keeling@neurosurgery.ufl.edu |
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 |
Principal Investigator: | Erin Dunbar, MD | University of Florida |
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 |
HGG anaplastic astrocytoma anaplastic oligodendroglioma anaplastic mixed glioma |
glioblastoma multiforme GBM Xeloda capecitabine |
Antimetabolites Neuroectodermal Tumors Glioblastoma Capecitabine Astrocytoma Neoplasms, Germ Cell and Embryonal |
Neuroepithelioma Oligodendroglioma Glioblastoma Multiforme Glioma Recurrence Neoplasms, Glandular and Epithelial |
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 |