Study of Capecitabine to Treat Recurrent High Grade Gliomas

NCT ID: NCT00717197

Last Updated: 2013-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2013-05-31

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.

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.

Conditions

Malignant Glioma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Capecitabine

Intervention Type: DRUG

1,000-1,250 mg/m2 taken by mouth twice daily for 14 out of 21 consecutive days until progression or unacceptable toxicity.

Interventions

Capecitabine

1,000-1,250 mg/m2 taken by mouth twice daily for 14 out of 21 consecutive days until progression or unacceptable toxicity.

Intervention Type: DRUG

Other Intervention Names

Xeloda

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erin Dunbar, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

University of Florida

Gainesville, Florida, United States

Countries

United States

Other Identifiers

HGG-001

Identifier Type: -

Identifier Source: org_study_id