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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Progression-free Survival.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Capecitabine (Drug)
结局指标
主要结局
Percentage of Participants With Progression-free Survival.
时间窗: From date of first dose of study drug until month 6.
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.
次要结局
未报告次要终点