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Study of Capecitabine to Treat Recurrent High Grade Gliomas

Primary Purpose

Malignant Glioma

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Capecitabine

About this trial

This is an interventional treatment trial for Malignant Glioma focused on measuring HGG, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed glioma, glioblastoma multiforme, GBM, Xeloda, capecitabine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Florida

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Capecitabine

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00717197

First Posted

July 15, 2008

Last Updated

June 24, 2013

Sponsor

University of Florida

1. Study Identification

Unique Protocol Identification Number

NCT00717197

Brief Title

Study of Capecitabine to Treat Recurrent High Grade Gliomas

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 Type

Interventional

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Completed

Study Start Date

July 2008 (undefined)

Primary Completion Date

March 2012 (Actual)

Study Completion Date

May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Florida

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malignant Glioma

Keywords

HGG, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed glioma, glioblastoma multiforme, GBM, Xeloda, capecitabine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Capecitabine

Arm Type

Experimental

Arm Description

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

Intervention Name(s)

Capecitabine

Other Intervention Name(s)

Xeloda

Intervention Description

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

Primary Outcome Measure Information:

Title

Percentage of Participants With Progression-free Survival.

Description

Time Frame

From date of first dose of study drug until month 6.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Erin Dunbar, MD

Organizational Affiliation

University of Florida

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Florida

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32610

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Study of Capecitabine to Treat Recurrent High Grade Gliomas

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