Radiolabeled Monoclonal Antibody Therapy and High-Dose Chemotherapy Followed By Autologous Peripheral Stem Cell Transplant in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
A Phase I Trial Combining IDEC-Y2B8 And High-Dose Beam Chemotherapy With Hematopoietic Progenitor Cell Transplant In Patients With Relapsed Or Refractory B-Cell Non-Hodgkin's Lymphoma
RATIONALE: Radiolabeled monoclonal antibodies such as yttrium Y90 ibritumomab tiuxetan can locate cancer cells and deliver radioactive cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining yttrium Y90 ibritumomab tiuxetan and chemotherapy with autologous stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: This phase I trial is studying how well giving yttrium Y90 ibritumomab tiuxetan with high-dose chemotherapy followed by autologous stem cell transplant work in treating patients with relapsed or refractory non-Hodgkin's lymphoma.
研究概览
地位
条件
详细说明
OBJECTIVES:
- Determine the maximum tolerated dose of yttrium Y 90 ibritumomab tiuxetan, in terms of absorbed radiation to critical organs, when administered with high-dose chemotherapy followed by autologous peripheral blood stem cell transplantation in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma.
- Determine whether the residual radioactivity detected at the time of stem cell reinfusion affects the reinfused cells and delays engraftment in patients treated with this regimen.
- Determine the duration of response and survival of patients treated with this regimen.
OUTLINE: This is a dose-escalation study of yttrium Y 90 ibritumomab tiuxetan (IDEC-Y2B8).
- Radioimmunotherapy: Patients receive rituximab IV followed by indium In 111 ibritumomab tiuxetan (for imaging) IV over 10 minutes on day -22. Patients then receive rituximab IV and IDEC-Y2B8 IV over 10 minutes on day -14.
Cohorts of 3-6 patients receive escalating doses of IDEC-Y2B8 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 3 of 6 patients experience dose-limiting toxicity.
- High-dose conditioning regimen: Patients receive BEAM chemotherapy comprising carmustine IV over 2 hours on day -6, etoposide IV over 2 hours twice daily and cytarabine IV over 1 hour twice daily on days -5 to -2, and melphalan IV over 1 hour on day -1.
- Autologous stem cell transplantation: Autologous peripheral blood stem cells are reinfused on day 0. Patients receive filgrastim (G-CSF) subcutaneously daily beginning on day 0 and continuing until blood counts recover.
Patients are followed at 30 days, 3 and 6 months, and then annually for 5 years.
PROJECTED ACCRUAL: A maximum of 42 patients will be accrued for this study.
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
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Illinois
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Chicago、Illinois、美国、60611-3013
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
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Chicago、Illinois、美国、60611-2998
- Hematology-Oncology Associates of Illinois
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Minnesota
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Rochester、Minnesota、美国、55905
- Mayo Clinic Cancer Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
DISEASE CHARACTERISTICS:
Histologically confirmed B-cell non-Hodgkin's lymphoma
- Relapsed or refractory disease
- CD20-positive disease
- Must have received at least 1 prior treatment regimen
- Complete remission with prior conventional salvage chemotherapy is allowed
- No more than 25% lymphoma in bone marrow
- No circulating malignant cells on blood smear
- No CNS involvement by lymphoma
- No HIV- or AIDS-related lymphoma
PATIENT CHARACTERISTICS:
Age
- Over 17
Performance status
- ECOG 0-2
Life expectancy
- At least 3 months
Hematopoietic
- Platelet count at least 100,000/mm^3
- Absolute neutrophil count at least 1,500/mm^3
Hepatic
- Transaminases less than 2 times normal
Renal
- Creatinine clearance greater than 50 mL/min
Cardiovascular
- LVEF at least 45%
Pulmonary
- Corrected DLCO at least 70% of predicted
- FEV_1 or FVC greater than 60%
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active infection
- No serious nonmalignant disease or other condition that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- More than 4 weeks since prior rituximab and recovered
- No other prior murine antibodies
- No prior stem cell transplantation
- No prior radioimmunoconjugate therapy
Chemotherapy
- See Disease Characteristics
- More than 6 weeks since prior nitrosoureas or mitomycin and recovered
Endocrine therapy
- No concurrent systemic corticosteroids
Radiotherapy
- Recovered from prior radiotherapy
- No prior external beam irradiation to more than 25% of the active bone marrow
Surgery
- More than 4 weeks since prior major surgery and recovered
Other
- More than 3 weeks since prior anticancer therapy
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:非随机化
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:治疗臂
|
Given at a dose of 5 μg/kg, subcutaneously daily, beginning on Day 0 (stem cell transplant day) until white blood cells measure greater than 1500/ul.
其他名称:
Intravenous infusion of 250 mg/m2 on treatment days -22 and -14 (day 0 = stem cell transplant).
Part of high dose BEAM chemotherapy given on study (a combination of carmustine, etoposide, cytarabine, and melphalan).
Carmustine is given at a dose of 300 mg/m2 intravenous infusion over a 2 hour period on treatment day -6 (Day 0 = stem cell transplant).
其他名称:
Part of high dose BEAM chemotherapy given on study (a combination of carmustine, etoposide, cytarabine, and melphalan).
Cytarabine is given at a dose of 100 mg/m2 intravenous infusion over a 1 hour period, every 12 hours on treatment days -5, -4, -3, and -2, for a total of 8 doses (Day 0 = stem cell transplant).
其他名称:
Part of high dose BEAM chemotherapy given on study (a combination of carmustine, etoposide, cytarabine, and melphalan).
Etoposide is given at a dose of 100 mg/m2 intravenous infusion over a 2 hour period every 12 hours on treatment days -5, -4, -3, and -2, for a total of 8 doses (Day 0 = stem cell transplant).
其他名称:
Part of high dose BEAM chemotherapy given on study (a combination of carmustine, etoposide, cytarabine, and melphalan).
Melphalan is given at a dose of 140 mg/m2 as an intravenous infusion over a 1 hour period on treatment day -1 (Day 0 = stem cell transplant).
On day 0, a minimum of 2.0 X 106 CD34+ cells/kg unselected peripheral blood progenitor cells (PBPC) will be reinfused following institutional guidelines for the reinfusion procedure.
Patients will receive 90Y2B8 at a variable dose on treatment day -14 (Day 0 = stell cell transplant).
The initial dose calculated to deliver no more than 100 cGy to critical organs (liver, lung).
Doses will be escalated based on cohort of enrollment.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Determine the maximum tolerated dose of absorbed radiation to critical organs delivered with this combination of study treatments
大体时间:From first study treatment until 30 days after last study treatment.
|
Dose limiting toxicities observed during and up to 30 days after the last study treatment resulting in the determination of the maximum tolerated dose of absorbed radiation to critical organs delivered by Y2B8 in combination with high-dose BEAM chemotherapy with autologous mobilized peripheral blood progenitor cell transplant
|
From first study treatment until 30 days after last study treatment.
|
合作者和调查者
出版物和有用的链接
一般刊物
- Winter J, Inwards D, Spies S, et al.: Zevalin® (90YZ) doses >.5 mCi/kg may be combined with high-dose beam and autotransplant (ASCT). [Abstract] Ann Oncol 16 (Suppl 5): A-215, v100, 2005.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- NU 99H11
- NU-99H11
- IDEC-NU99H11
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