A Phase 2 Study of Idarubicin Based Combined Modality Therapy in Primary Central Nervous System Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 15
- 主要终点
- To estimate the median and 2 year overall survival.
研究概览
简要总结
Idarubicin combined with high dose methotrexate and moderate dose radiotherapy will achieve similar survival outcomes but with reduced neurotoxicity compared to regimens using methotrexate with high dose radiotherapy.
详细描述
Combined modality therapy in PCNSL has improved survival outcomes but at the cost of unacceptable rates of neurotoxicity when high dose radiotherapy is used. Idarubicin has activity in systemic lymphomas and crosses the blood brain barrier and may add to the efficacy of methotrexate. By combining these 2 drugs with moderate dose radiotherapy survival outcomes should be optimal but with lower rates of neurotoxicity.
Comparison: TROG has previously performed a phase 2 study using methotrexate with high dose radiotherapy and this will allow comparison of survival and neurotoxicity rates.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven primary CNS lymphoma.
- •Absence of disease outside the CNS.
- •ECOG performance status 0-3
- •Negative HIV status.
- •Peripheral blood counts with granulocytes >1.5 x 109L and platelets > 100 x 109L. Serum creatinine <150mmol/L. Serum bilirubin <1.5 times and AST <2 times upper limit of normal.
- •Age >18 and <=70 years.
- •Patients must give written informed consent.
- •Corticosteroids prior to histological diagnosis are allowed.
排除标准
- •Previous history of malignancy (other than non-melanomatous skin carcinoma, or carcinoma in situ of cervix completely excised).
- •Patients who are pregnant or lactating.
- •NYHA (New York State Heart Association classification) cardiac failure grade 3
- •Macroscopic spinal thecal or spinal cord disease.
研究组 & 干预措施
1
干预措施: Idarubicin, Methotrexate, Filgrastim, intrathecal Ara-C (Drug)
1
干预措施: Radiation Therapy (Radiation)
结局指标
主要结局
To estimate the median and 2 year overall survival.
时间窗: Estimate of survival at 2 years and at 5 years.
次要结局
- To estimate the risk of late neurotoxicity relative to results achieved in TROG 92.01.(Analysis at 3 years.)
- Assess acute toxicity.(Interim actute toxicity analyses will be performed at accrual points: 5, 10, 15, 20 and 25 patients.)
- Assess functional indices of living in patients with PCNSL.(Analysis will be at 5 years.)