Pilot Study to Determine Therapeutic Response of Pemetrexed (Alimta) in Recurrent or Progressive Primary Central Nervous System Lymphoma (PCNSL) by Establishing the Radiographic Response Rate Using Modified Macdonald Criteria
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Determine the therapeutic response of intravenous pemetrexed in recurrent or progressive primary central nervous system lymphoma by establishing the radiographic response rate using modified Macdonald criteria.
研究概览
简要总结
The purpose of this study is to determine if pemetrexed is effective in the treatment of primary central nervous system lymphoma (PCNSL) that has either worsened during treatment or has returned after completing treatment.
详细描述
Despite the aggressive upfront use of methotrexate-based chemotherapy, primary central nervous system lymphoma (PCNSL) almost uniformly results in recurrence or progression and death. Palliative chemotherapy offers an improvement in time-to-progression, symptom control, quality of life, and potentially, survival. However, no established chemotherapy regimen for recurrence exists and new treatments are needed. Pemetrexed is a rationale strategy for therapeutic palliation of recurrent or progressive PCNSL, given its mechanism of action, convenient administration, single agent efficacy, its well established management algorithms, and its evidence of safety and efficacy in systemic malignancies.
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 Primary Central Nervous System Lymphoma
- •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
- •Platelet > 100,000
- •Absolute Neutrophil Count > 1,500
- •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
- •Creatinine Clearance > 45 mL/min
- •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 patient informed consent form
- •Ability and willingness to follow all requirements of the study including following all directions, taking medication as prescribed, and completion of all diaries and forms
排除标准
- •Karnofsky Performance Status < 60
- •Hematocrit < 30,000
- •Platelet < 100,000
- •Absolute Neutrophil Count < 1,500
- •Bilirubin >1.5 x upper limits of normal
- •Transaminases (ALT & AST) > 1.5 x upper limits of normal
- •Creatinine > 1.5 x upper limits of normal
- •Creatinine Clearance < 45 mL/min
- •Inability to undergo gadolinium-contrasted MRIs, including severe claustrophobia or insufficient allergy prophylaxis
研究组 & 干预措施
Pemetrexed
500 mg/m2 given as an injection into a vein over 10 minutes once every 21 days until progression or unacceptable toxicity.
干预措施: Pemetrexed (Drug)
结局指标
主要结局
Determine the therapeutic response of intravenous pemetrexed in recurrent or progressive primary central nervous system lymphoma by establishing the radiographic response rate using modified Macdonald criteria.
时间窗: 2.5 Years
次要结局
- Evaluate the longitudinal effect of intravenous pemetrexed on traditional quality of life and performance status measurements.(2.5 Years)
- Evaluate the longitudinal tolerability of intravenous pemetrexed using standardized toxicity criteria.(2.5 Years)