NCT00616720已完成2 期
Randomized Phase II Trial of Dendritic Cell-Based Idiotype Vaccination With Adjuvant Cytokines for Plateau Phase and Post-Transplant Multiple Myeloma
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 15
- 主要终点
- Confirmed response (i.e., clinical or immunological)
研究概览
简要总结
RATIONALE: Biological therapies, such as interferon-gamma and aldesleukin, may stimulate the immune system in different ways and stop cancer cells from growing. Vaccines made from a person's white blood cells may help the body build an effective immune response to kill cancer cells. Giving biological therapy together with vaccine therapy may kill more cancer cells.
PURPOSE: This randomized phase II trial is studying how well giving aldesleukin or interferon gamma together with vaccine therapy works in treating patients with multiple myeloma.
详细描述
OBJECTIVES:
Primary
- To assess the clinical benefit in patients with plateau phase multiple myeloma treated with interferon-gamma vs aldesleukin in combination with idiotype-pulsed autologous dendritic cell vaccine APC8020.
- To describe response rates in patients who are in plateau phase status post-chemotherapy or status post-peripheral blood cell transplantation treated with this regimen.
Secondary
- To obtain data regarding the ability of this approach to produce an anti-idiotypic immunologic response.
- To obtain information about the effects of interferon-gamma and aldesleukin on the number, function, and activation state of immune effector-cells including T-cells and B-cells.
- To perform detailed analyses of lymphocyte phenotypes and T-cell repertoires before and after idiotype-pulsed autologous dendritic cell vaccine APC8020.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Confirmed response (i.e., clinical or immunological)
次要结局
未报告次要终点
研究者
相似试验
Unknown
2 期
Vaccine Therapy in Treating Patients With Stage III or Stage IV MelanomaMelanoma (Skin)NCT00085397Dana-Farber Cancer Institute40
已完成
1 期
Denileukin Diftitox Used in Treating Patients With Advanced Refractory Ovarian Cancer, Primary Peritoneal Carcinoma, or Epithelial Fallopian Tube CancerFallopian Tube CancerOvarian Clear Cell CystadenocarcinomaOvarian Endometrioid AdenocarcinomaOvarian Mixed Epithelial CarcinomaOvarian Mucinous CystadenocarcinomaOvarian Serous CystadenocarcinomaOvarian Undifferentiated AdenocarcinomaPeritoneal Cavity CancerRecurrent Ovarian Epithelial CancerStage III Ovarian Epithelial CancerStage IV Ovarian Epithelial CancerNCT00357448University of Washington11
撤回
2 期
Lymphokine-Activated Killer Cells or Gliadel Wafer in Treating Patients With Newly Diagnosed Glioblastoma Multiforme That Can Be Removed by SurgeryBrain and Central Nervous System TumorsNCT00814593Lisata Therapeutics, Inc.
已完成
1 期
Fusion Protein Cytokine Therapy After Rituximab in Treating Patients With B-Cell Non-Hodgkin LymphomaCutaneous B-cell Non-Hodgkin LymphomaAnaplastic Large Cell LymphomaExtranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid TissueIntraocular LymphomaNodal Marginal Zone B-cell LymphomaRecurrent Adult Diffuse Small Cleaved Cell LymphomaRecurrent Adult Grade III Lymphomatoid GranulomatosisRecurrent Grade 1 Follicular LymphomaRecurrent Grade 2 Follicular LymphomaRecurrent Marginal Zone LymphomaSmall Intestine LymphomaSplenic Marginal Zone LymphomaTesticular LymphomaWaldenstrom MacroglobulinemiaNCT00720135City of Hope Medical Center9
已完成
2 期
Cellular Adoptive Immunotherapy in Treating Patients With Glioblastoma MultiformeBrain and Central Nervous System TumorsNCT00331526Hoag Memorial Hospital Presbyterian83