Clinical trial · Interventional
Study of Capecitabine to Treat Recurrent High Grade Gliomas
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
NCT00717197CI-TRIAL-00011188completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Glioma | Malignant Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Capecitabine
- 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.
- interventionNames
- Drug: Capecitabine
Primary outcomes (1)
- measure
- Percentage of Participants With Progression-free Survival.
- timeFrame
- From date of first dose of study drug until month 6.
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.