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Study of Capecitabine to Treat Recurrent High Grade Gliomas

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00717197
First received: July 15, 2008
Last updated: June 24, 2013
Last verified: June 2013
  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
Malignant Glioma
Drug: Capecitabine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Percentage of Participants With Progression-free Survival. [ Time Frame: From date of first dose of study drug until month 6. ] [ Designated as safety issue: No ]
    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.


Enrollment: 30
Study Start Date: July 2008
Study Completion Date: May 2013
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00717197     History of Changes
Other Study ID Numbers: HGG-001
Study First Received: July 15, 2008
Results First Received: February 18, 2013
Last Updated: June 24, 2013
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

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

ClinicalTrials.gov processed this record on November 20, 2014