NCT00361296终止1 期
K562/GM-CSF Vaccination in Patients With Myelodysplastic Syndrome
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2007年9月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Hematologic Response Rate as Assessed by Number of Participants Achieving a Major Hematologic Response
研究概览
简要总结
RATIONALE: Vaccines made from cancer cells may help the body build an effective immune response to kill abnormal cells.
PURPOSE: This clinical trial is studying how well vaccine therapy works in treating patients with myelodysplastic syndromes (MDS).
详细描述
OBJECTIVES:
Primary
- Determine the safety of GM-K562 cell vaccine in patients with myelodysplastic syndromes.
- Determine the hematologic and cytogenetic response in patients treated with this vaccine.
Secondary
- Determine if vaccination with GM-K562 cell vaccine can induce an immune response to common myeloid antigens (e.g., Wilms' tumor-1 [WT-1], survivin, or proteinase-3), as defined by a 30% increase from baseline in specific cytotoxic T-cells measured by Elispot assay, in patients with myelodysplastic syndromes.
- Determine if immune response correlates with any clinical responses (e.g., hematologic response, resolution of cytogenetic abnormalities, or decrease in other parameters, such as WT-1 mRNA levels).
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
- •DISEASE CHARACTERISTICS:
- •Pathologically confirmed myelodysplastic syndromes (MDS), including any of the following:
- •Refractory anemia (RA)
- •RA with ringed sideroblasts
- •Refractory cytopenias with multilineage dysplasia (RCMD)
- •RCMD with ringed sideroblasts
- •RA with excess blasts 1 (5-9% blasts)
- •RA with excess blasts 2 (10-19% blasts)
- •Must have poor-risk MDS, defined by the following:
- •At least 2 lineages involved
- •Unfavorable cytogenetics (i.e., abnormalities of chromosome 5 or 7, 11q23, t[6;9], trisomy 8, inv3, or multiple/complex karyotype)
- •Transfusion requirement of > 2 units of packed red blood cells monthly
- •No chronic myelomonocytic leukemia
- •No transformation to acute myeloid leukemia
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Creatinine < 2.5 mg/dL
- •Bilirubin < 2.5 mg/dL (unless due to Gilbert's syndrome)
- •Room air oxygen saturation ≥ 94% at rest
- •Fertile patients must use effective contraception
- •Negative pregnancy test
- •No other malignancy within the past 5 years except in situ cervical cancer or adequately treated nonmelanoma skin cancer
- •No active autoimmune disease or history of autoimmune disease requiring systemic immunosuppressants including, but not limited to, any of the following:
- •Autoimmune hemolytic anemia
- •Idiopathic thrombocytopenia purpura
- •Inflammatory bowel disease
- •Vasculitis
- •Thyroiditis
- •Rheumatic illnesses
- •No known HIV serum antibody positivity
- •No other disease requiring long-term corticosteroids or other immunosuppressants, such as severe chronic obstructive pulmonary disease or asthma
- •PRIOR CONCURRENT THERAPY:
- •At least 2 weeks since prior systemic corticosteroids or other immunosuppressants (e.g., cyclosporine, azathioprine, tacrolimus, or mycophenolate mofetil)
- •At least 3 weeks since prior growth factors
- •At least 2 months since prior azacitidine for MDS
- •No prior bone marrow or other organ transplantation
- •No concurrent cytotoxic-based therapy for MDS
- •No other concurrent growth factors, including epoetin alfa, filgrastim (G-CSF), or sargramostim (GM-CSF)
排除标准
- 未提供
研究组 & 干预措施
K562/GM-CSF cell vaccine
Experimental
Vaccinations of 1x10^8 cells are given to participants at weeks 0, 3, 6, 9, and 17.
干预措施: K562/GM-CSF cell vaccine (Biological)
结局指标
主要结局
Hematologic Response Rate as Assessed by Number of Participants Achieving a Major Hematologic Response
时间窗: Baseline, week 21 post-intervention
A major hematologic response is defined as any of the following: hemoglobin increase \>= 2 g/dL from baseline; platelet increase \>= 30k/mcL from baseline; or neutrophil increase \>= 100% or \>= 500/mcL from baseline.
Cytogenetic Response Rate as Assessed by Number of Participants Achieving a Cytogenetic Response
时间窗: Week 21
Cytogenetic response is defined as normalization of pretreatment cytogenetic abnormalities.
次要结局
- Immune Response Rate as Assessed by Number of Participants Who Exhibit Induced Immune Response to WT-1, Survivin, or Proteinase-3(Baseline, week 21 post-intervention)
- Combined Immune and Clinical Response Rate(Week 21 post-intervention)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Vaccine Therapy in Treating Patients With Myelodysplastic SyndromeMyelodysplastic SyndromesLeukemiaNCT00003959Memorial Sloan Kettering Cancer Center1
已完成
1 期
Vaccine Therapy and Imatinib Mesylate in Treating Patients With Chronic Phase Chronic Myelogenous LeukemiaLeukemiaNCT00301093Dana-Farber Cancer Institute3
已完成
2 期
Vaccine Therapy in Treating Patients With Multiple MyelomaStage II Multiple MyelomaStage III Multiple MyelomaRefractory Plasma Cell NeoplasmNCT00019097National Cancer Institute (NCI)
已完成
1 期
Vaccine Therapy in Treating Patients With Stage IIIB, Stage IIIC, or Stage IV MelanomaIntraocular MelanomaMelanoma (Skin)NCT00089219University of Virginia39
已完成
2 期
Vaccine Therapy With or Without Sargramostim in Treating Patients With Stage IIB, Stage IIC, Stage III, or Stage IV MelanomaMelanoma (Skin)NCT00089193Craig L Slingluff, Jr