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Clinical Trial Finder

Study of Capecitabine to Treat Recurrent High Grade Gliomas

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00717197
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of Florida
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Erin Dunbar, MD
Principal Investigator Affiliation University of Florida
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Malignant Glioma
Additional Details

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.

Arms & Interventions

Arms

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.

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Florida, Gainesville, Florida

Status

Address

University of Florida

Gainesville, Florida, 32610

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