Study of Capecitabine to Treat Recurrent High Grade Gliomas

Malignant Glioma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00717197
• Other study ID #: HGG-001
• Status: Completed
• Phase: Phase 2
• First received: July 15, 2008
• Last updated: June 24, 2013
• Start date: July 2008
• Est. completion date: May 2013

Study information

• Verified date: June 2013
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2013
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glioma
• Malignant Glioma

Intervention

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.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Progression-free Survival.	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.	From date of first dose of study drug until month 6.	No