Study of Capecitabine to Treat Recurrent High Grade Gliomas

• 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: University of Florida
• Information provided by (Responsible Party): University of Florida

Study Description

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 30 participants
• Allocation: N/A
• 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

Arms and Interventions

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

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

• 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

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

• Responsible Party: University of Florida
• ClinicalTrials.gov Identifier: NCT00717197
• Other Study ID Numbers: HGG-001
• First Posted: July 17, 2008
• 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