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Study of Capecitabine to Treat Recurrent High Grade Gliomas

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ClinicalTrials.gov Identifier: NCT00717197
Recruitment Status : Completed
First Posted : July 17, 2008
Results First Posted : March 25, 2013
Last Update Posted : July 2, 2013
Sponsor:
Information provided by (Responsible Party):
University of Florida

Study Description
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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.

Condition or disease Intervention/treatment Phase
Malignant Glioma Drug: Capecitabine Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2008
Actual Primary Completion Date : March 2012
Actual Study Completion Date : May 2013

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 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.
Other Name: Xeloda


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With Progression-free Survival. [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00717197


Locations
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Erin Dunbar, MD University of Florida
More Information
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00717197     History of Changes
Other Study ID Numbers: HGG-001
First Posted: July 17, 2008    Key Record Dates
Results First Posted: March 25, 2013
Last Update Posted: July 2, 2013
Last Verified: June 2013

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

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