Study of Capecitabine to Treat Recurrent High Grade Gliomas

NCT00717197 | Completed Phase 2 Results DMC

• 1 other identifier: HGG-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Glioma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Capecitabine

EXPERIMENTAL

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

Interventions

Capecitabine DRUG

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

Also known as: Xeloda

Capecitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Glioma; Astrocytoma; Oligodendroglioma; Glioblastoma

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Erin M. Dunbar, MD
• Organization: University of Florida

edunbar@neurosurgery.ufl.edu

(352) 273-9000

Study Officials

• Erin Dunbar, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2008
• First Posted: July 17, 2008
• Study Start: July 1, 2008
• Primary Completion: March 1, 2012
• Study Completion: May 1, 2013
• Last Updated: July 2, 2013
• Results First Posted: March 25, 2013

Record last verified: 2013-06

Locations

US (1)