NCT00104819终止2 期
Phase II Trial of FavId™ (Patient-Specific Idiotype/KLH) and GM-CSF in Subjects Who Demonstrated Progressive Disease and Did Not Receive FavId on Study FavId-06
Favrille101 个研究点 分布在 1 个国家目标入组 238 人开始时间: 2004年9月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 238
- 试验地点
- 101
- 主要终点
- Autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId)™ provided to patients who did not receive autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId)™ during participation on study Favld-06
研究概览
简要总结
RATIONALE: Vaccines made from a person's cancer cells may make 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 and may stimulate the immune system in different ways and stop cancer cells from growing.
PURPOSE: This phase II trial is studying how well giving vaccine therapy together with GM-CSF works in treating patients with progressive B-cell non-Hodgkin's lymphoma.
详细描述
OBJECTIVES:
Primary
- Provide treatment with autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId)™ and sargramostim (GM-CSF) to patients with progressive grade 1, 2, or 3 follicular B-cell non-Hodgkin's lymphoma who did not receive FavId™ while enrolled on protocol FAV-ID-06.
Secondary
- Determine the response rate and duration of response in patients treated with this regimen.
- Determine the response rate and response rate improvement after best response to prior salvage therapy in patients treated with this regimen.
- Determine the time to progression in patients treated with this regimen.
- Determine the safety of this regimen in these patients.
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 follicular B-cell non-Hodgkin's lymphoma (NHL)
- •Grade 1, 2, or 3
- •Progressive disease AND did not receive autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId™) while enrolled on protocol FAV-ID-06
- •Meets 1 of the following criteria:
- •Received salvage therapy after completion of protocol FAV-ID-06
- •At least 4 weeks, but no more than 4 months, since prior salvage therapy
- •Did not receive salvage therapy after completion of protocol FAV-ID-06
- •At least 4 weeks, but no more than 4 months, since completion of prior treatment on protocol FAV-ID-06
- •No history of CNS lymphoma OR meningeal lymphomatosis
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •Not specified
- •Not specified
- •Cardiovascular
- •No history of congestive heart failure
- •No history of compromised pulmonary function
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •HIV negative
- •No active bacterial, viral, or fungal infection
- •No psychiatric disorder
- •No other serious nonmalignant disease that would preclude study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •See Disease Characteristics
- •No prior allogeneic transplantation*
- •No prior rituximab regimen* other than that administered on protocol FAV-ID-06 (rituximab 375 mg/m^2 IV weekly for 4 weeks)
- •Chemotherapy
- •No prior purine analogues* (e.g., fludarabine or cladribine)
- •Endocrine therapy
- •No prior or concurrent steroids (e.g., steroid doses in excess of daily replacement)
- •Radiotherapy
- •Not specified
- •Not specified
- •Recovered from prior salvage therapy
- •No prior or concurrent immunosuppressive therapy
- •No prior investigational agents*
- •No other concurrent antilymphoma therapy NOTE: *As salvage therapy administered between completion of protocol FAV-ID-06 and enrollment onto this study
排除标准
- 未提供
结局指标
主要结局
Autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId)™ provided to patients who did not receive autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId)™ during participation on study Favld-06
次要结局
- Response rate by modified Cheson Criteria
- Duration of response by modified Cheson Criteria
- Time to progression
- Response rate improvement
研究者
研究点 (101)
Loading locations...
相似试验
终止
2 期
Vaccine Therapy Following Chemotherapy & Peripheral Stem Cell Transplantation in Treating Non-Hodgkin's LymphomaLymphomaNCT00006478University of Nebraska19
已完成
2 期
Vaccine Therapy With or Without Interleukin-12 in Treating Patients With Stage III or Stage IV MelanomaIntraocular MelanomaMelanoma (Skin)NCT00003339University of Southern California48
终止
1 期
Vaccine Therapy in Patients With Stages IIIB/IV Non-Small Cell Lung Cancer Who Have Finished First-Line ChemotherapyLung CancerNCT00534209University of Miami1
已完成
2 期
Tumor Cell Vaccine in Treating Patients With Advanced CancerUnspecified Adult Solid Tumor, Protocol SpecificNCT00002505Hoag Memorial Hospital Presbyterian
撤回
2 期
Vaccine Therapy and GM-CSF in Treating Patients With CNS LymphomaBrain and Central Nervous System TumorsLymphoproliferative DisorderSmall Intestine CancerLymphomaNCT00621036University of Texas Southwestern Medical Center