A Pilot Study of Combined Immunochemotherapy Followed by Reduced Dose RT for Patients With Newly Diagnosed Primary Central Nervous System Lymphoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Total Number of Participants Who Experienced Acute Treatment Related Adverse Events
研究概览
简要总结
The purpose of this study is to find out if immunotherapy (rituximab) added to chemotherapy is a safe treatment for primary central nervous system lymphoma (PCNSL). PCNSL is a rare tumor. It is usually treated with chemotherapy and radiation. This combination prolongs survival, but about half of patients relapse. The investigators hope that the addition of rituximab will improve the control of the tumor.
详细描述
The purpose of this study is to find out if immunotherapy (rituximab) added to chemotherapy is a safe treatment for primary central nervous system lymphoma (PCNSL). PCNSL is a rare tumor. It is usually treated with chemotherapy and radiation. This combination prolongs survival, but about half of patients relapse. We hope that the addition of rituximab will improve the control of your tumor.
The second goal of this study is to assess a lower dose of brain radiation. Brain radiation may cause memory loss or dementia. For patients over the age of 60, the risk of significant memory loss is 80-90%. The risk for younger patients is smaller but less clear. In this, study patients whose tumors are in remission after chemotherapy will be treated with a lower dose of brain radiation. We hope that this lower dose will be less toxic. However, it is also possible that using a lower dose of radiation will be less effective in controlling your tumor.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients must have a histologic diagnosis of non-Hodgkin's lymphoma by brain biopsy. Patients who have an inconclusive biopsy or who are not candidates for biopsy may be eligible provided they have a typical cranial magnetic resonance imaging (MRI) or computed tomography (CT) scan and meet at least one of the following two criteria:
- •A positive cerebrospinal fluid (CSF) cytology for lymphoma or a monoclonal lymphocyte population as defined by cell surface markers
- •A biopsy of the vitreous or uvea demonstrating non-Hodgkin's lymphoma
- •A typical MRI/CT scan for primary intracranial lymphoma is defined as the presence of hypo, iso, or hyperdense parenchymal contrast-enhancing (usually homogeneously) mass lesion(s)
- •Patients must be HIV-1 negative
- •Patients must have a normal or negative pre-treatment systemic evaluation including:
- •A bone marrow aspirate and biopsy
- •CT scans of the chest, abdomen and pelvis
- •Patients must have adequate bone marrow function (defined as peripheral leucocyte count > 4000 cells/mm3 and platelet count > 100,000 cells/mm3), liver function (bilirubin < 2.0 mg and SGOT < 2 times upper limit of normal), and adequate renal function (serum creatinine < 1.5 mg/dl or creatinine clearance > 50 cc/min/1.73M2)
- •Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for six months after completion of treatment
排除标准
- •The following would exclude a patient from the study:
- •Prior cranial irradiation
- •Other active primary malignancy with the exception of basal cell carcinoma of the skin and cervical carcinoma in situ
- •Pre-existing immunodeficiency such as renal transplant recipient
- •Prior treatment with chemotherapy for CNS lymphoma
研究组 & 干预措施
1
干预措施: Cytarabine, Leucovorin, Methotrexate, Procarbazine, Rituximab, Vincristine (Drug)
结局指标
主要结局
Total Number of Participants Who Experienced Acute Treatment Related Adverse Events
时间窗: 2 years
The toxicity of this combined regimen will be measured using the NCI CTC version 2.0.
Progression Free Survival
时间窗: 2 Years
Overall Progression Free Survival at 2 years
次要结局
未报告次要终点