Phase II Study of Radioimmunotherapy With Zevalin (Ibritumomab Tiuxetan) Therapy for Patients With Refractory or Relapsed Primary Central Nervous System Lymphoma (PCNSL)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Radiographic Response Assessed by MRI or FDG-PET/MRI
研究概览
简要总结
This phase II trial studies how well yttrium Y 90 ibritumomab tiuxetan and rituximab work in treating patients with recurrent or refractory primary central nervous system non-Hodgkin lymphoma. Radiolabeled monoclonal antibodies, such as yttrium 90 ibritumomab tiuxetan, can find cancer cells and carry cancer-killing substances to them without harming normal cells. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving yttrium Y 90 ibritumomab tiuxetan with rituximab may kill more cancer cells.
详细描述
PRIMARY OBJECTIVES:
I. Determine the radiographic response proportion in patients with refractory or recurrent primary central nervous system lymphoma (PCNSL) to ibritumomab tiuxetan (yttrium Y 90 ibritumomab tiuxetan) when given as an intravenous infusion.
SECONDARY OBJECTIVES:
I. Determine the progression free survival of patients treated with ibritumomab tiuxetan when given as an intravenous infusion.
II. Determine the overall survival of patients treated with ibritumomab tiuxetan when given as an intravenous infusion.
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
- •Patients with histological diagnosis of recurrent or refractory primary central nervous system (CNS) lymphoma with at least 1 measurable gadolinium enhancing lesion on brain MRI scans
- •Karnofsky performance status (KPS) >= 60
- •Patients could not have had more than 3 prior therapy regimens for the treatment of PCNSL
- •Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
- •Platelets >= 100 x 10^9/L
- •Hemoglobin (Hgb) > 10 g/dL
- •Serum total bilirubin =< 1.5 x upper limit of normal (ULN)
- •Alanine aminotransferase (ALT) =< 3.0 x ULN
- •Aspartate aminotransferase (AST) =< 3.0 x ULN
- •Serum creatinine =< 1.5 x ULN
- •Minimum interval since completion of radiation treatment is 12 weeks
- •Minimum interval since last drug therapy:
- •3 weeks since the completion of non-cytotoxic agents
- •4 weeks since the completion of a non-nitrosourea-containing regimen
- •6 weeks since the completion of a nitrosourea-containing regimen
- •Patients must have signed an approved informed consent and authorization permitting release of personal health information
- •Patients are not on corticosteroids or on stable doses (less than 6 mg daily of dexamethasone) for more than 1 week before baseline imaging
- •Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception
- •Patients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix and breast, adequately treated stage I or II cancer from which the patient is in complete remission; patients with other prior malignancies must be disease-free for >= three years
排除标准
- •Pregnant or breast-feeding women
- •Patients unwilling or unable to comply with the protocol
- •Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g. active infection, uncontrolled diabetes, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, or psychiatric illness, etc.) that could cause unacceptable safety risks or compromise compliance with the protocol
- •Known diagnosis of human immunodeficiency virus (HIV) infection; prior radioimmunotherapy, prior myeloablative therapy with autologous bone marrow transplantation or peripheral stem cell rescue, and prior external beam radiation therapy to more than 25% of active bone marrow
- •Patients who have received filgrastim (G-CSF) or sargramostim (GM-CSF) within 2 weeks before treatment or major surgery within the prior 4 weeks
结局指标
主要结局
Radiographic Response Assessed by MRI or FDG-PET/MRI
时间窗: Up to 2 years
Number of patients with at least a 50% reduction in tumor size on a MRI scan with stable or decreasing dose of corticosteroids
次要结局
- Progression Free Survival(Up to 2 years)
- Overall Survival(Up to 2 years)
- Establish the Toxicity Profile of Ibritumomab Tiuxetan in This Patient Population.(Up to 30 days following the last dose of study treatment)
- Dosimetry Calculations of Yttrium Y 90 Ibritumomab Tiuxetan Assessed by PET/MRI(At day 11)