NCT00258336Unknown2 期
Phase II Trial of Maintenance Rituximab Plus FavId® and GM-CSF Immunotherapy in Patients With Treatment-Naive Indolent B-Cell Lymphoma
Favrille2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2004年8月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Event-free survival by Kaplan-Meier
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Vaccines made from a person's cancer cells may help the body build an effective immune response to kill cancer cells. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving rituximab together with vaccine therapy and GM-CSF may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving rituximab together with vaccine therapy and GM-CSF works in treating patients with indolent B-cell non-Hodgkin's lymphoma.
详细描述
OBJECTIVES:
- Determine the efficacy of immunotherapy comprising rituximab, autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId™), and sargramostim (GM-CSF), in terms of response rate (partial and complete) and event-free survival, in patients with indolent B-cell non-Hodgkin's lymphoma.
- Determine the safety of this regimen in these patients.
- Evaluate development of an immune response in patients treated with this regimen.
OUTLINE: This is an open-label, multicenter study.
- Induction therapy: Patients receive rituximab IV over 2-4 hours once weekly for 4 weeks. Patients are evaluated for response at month 3. Patients with responding or stable disease proceed to maintenance therapy. Patients with progressive disease are removed from study.
- Maintenance therapy: Patients receive rituximab as in induction therapy in months 7, 13, and 19. Patients also receive autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId™) subcutaneously (SC) once on day 1 and sargramostim (GM-CSF) SC once daily on days 1-4 in months 4-6, 8-11, 14, 16, 18, 20, 22, and 24. Patients with continued response after completing 2 years of therapy may continue to receive FavId™ and GM-CSF once every 3 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
研究设计
- 研究类型
- Interventional
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed indolent B-cell non-Hodgkin's lymphoma of 1 of the following subtypes:
- •Grade 1 or 2 follicular lymphoma
- •Tumor must be accessible to biopsy or biopsy material available for preparation of autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId™)
- •Measurable or evaluable disease after node biopsy
- •No mantle cell, marginal zone, MALT-type, small lymphocytic, or grade 3 follicular (follicular large cell) lymphoma
- •No CNS involvement with lymphoma
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Platelet count > 100,000/mm^3
- •WBC ≥ 3,000/mm^3
- •AST and ALT ≤ 2 times upper limit of normal
- •Bilirubin ≤ 2 mg/dL
- •Creatinine ≤ 1.5 mg/dL
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 30 days after completion of study treatment
- •HIV negative
- •No other medical or psychiatric disease that would preclude study compliance
- •No other malignancy (active or treated) within the past 5 years
- •PRIOR CONCURRENT THERAPY:
- •Radiotherapy
- •Prior local radiotherapy allowed
- •No other prior anticancer therapy
排除标准
- 未提供
结局指标
主要结局
Event-free survival by Kaplan-Meier
次要结局
- Immune response by cellular or humoral anti-idiotype response positive
- Safety
- Overall response rate (partial and complete response) at month 6 and any time
- Time-to-progression by Kaplan-Meier
- Duration of response
研究者
研究点 (2)
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