Study of Capecitabine to Treat Recurrent High Grade Gliomas
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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 |
- 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 |
| Estimated Study Completion Date: | July 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 |
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 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: | April 11, 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, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Capecitabine Fluorouracil |
Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013