Phase I Trial of Post Transplant Immunization With Autologous Myeloma Idiotype-KLH/GM-CSF In Myeloma Patients Following Autologous or Allogeneic Marrow or Stem Cell Transplantation
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Toxicities graded using the National Cancer Institute (NCI) Common Toxicity Criteria
研究概览
简要总结
The purpose of this trial is to test the safety and immune response to four immunizations with this vaccine made from a protein produced by the patient's tumor. There is no guarantee or promise that this procedure will be successful
详细描述
PRIMARY OBJECTIVES:
I. To determine the safety of multiple subcutaneous vaccinations with myeloma Id-KLH (idiotype-keyhole limpet hemocyanin) with GM-CSF (sargramostim) in post allogeneic transplant myeloma patients, or with GM-CSF +/- interleukin (IL)-2 (aldesleukin) in post autologous transplant myeloma patients.
II. To evaluate patients pre and post bone marrow transplantation (BMT) for evidence of endogenous idiotype specific immune response.
III. To characterize the time course, specificity and persistence of antibody and T cell immune response to myeloma idiotype and to KLH induced by myeloma Ig (Id) immunization.
IV. To clone, expand and characterize T cells specific for the tumor idiotype. V. Monitor myeloma involvement in bone marrow and serum paraprotein level following vaccination.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ELIGIBILITY FOR VACCINE PREPARATION:
- •Patients must have a diagnosis of multiple myeloma and be eligible for a Fred Hutchinson Cancer Research Center (FHCRC) treatment protocol using high dose therapy with syngeneic, allogeneic or autologous marrow or stem cell transplantation
- •Pretransplant sera available with immunoglobulin A (IgA), immunoglobulin D (IgD), immunoglobulin E (IgE), immunoglobulin G (IgG), or immunoglobulin M (IgM) monoclonal paraprotein with a level of 1.5 grams/dl or greater identifiable on serum protein electrophoresis; eligibility for patients with pretransplant paraprotein levels of less than 1.5 gm/dl will be evaluated on an individual basis to determine whether purification of idiotype is feasible
- •ELIGIBILITY FOR POST-TRANSPLANT IDIOTYPE VACCINATION:
- •Successful isolation and production of an autologous idiotype vaccine from pre-BMT sera
- •Greater than 60 days post BMT
- •Achievement of a partial remission or greater (more than 75% reduction in serum paraprotein) for patients transplanted in relapse
- •Stable absolute neutrophil count (ANC) > 1000
- •Platelet count > 50,000 not requiring transfusions or growth factors
- •Red blood cell (RBC) supportable to hematocrit (Hct) > 25 with less than 2 units of packed red blood cell (PRBC)/week
- •Treatment with a stable dose of Interferon is allowed
- •Karnofsky status > 60 percent
- •Immunosuppression:
- •Off all corticosteroids
- •Either off all immunosuppressive medications or on a stable/tapering dose of cyclosporin or FK506 only
排除标准
- •Graft-vs-host disease requiring treatment with corticosteroids
- •Serum creatinine > 3.0
- •Uncontrolled infection
- •Disease progression
- •Presence of medical complication that in the opinion of the investigators would result in inability to tolerate the vaccination protocol
- •Patients with a history of serious adverse reactions to GM-CSF
- •Patients with a history of serious adverse reactions to IL-2 will not receive concurrent IL-2 administration but may receive the Id-KLH vaccine with GM-CSF
研究组 & 干预措施
Treatment (vaccine therapy)
Patients receive autologous immunoglobulin idiotype-KLH conjugate vaccine combined with sargramostim SC in weeks 0, 2, 6, and 10 and sargramostim SC QD for three days following each vaccine injection. Some patients also receive aldesleukin SC daily from weeks 2-14.
干预措施: sargramostim (Biological)
Treatment (vaccine therapy)
Patients receive autologous immunoglobulin idiotype-KLH conjugate vaccine combined with sargramostim SC in weeks 0, 2, 6, and 10 and sargramostim SC QD for three days following each vaccine injection. Some patients also receive aldesleukin SC daily from weeks 2-14.
干预措施: autologous immunoglobulin idiotype-KLH conjugate vaccine (Biological)
Treatment (vaccine therapy)
Patients receive autologous immunoglobulin idiotype-KLH conjugate vaccine combined with sargramostim SC in weeks 0, 2, 6, and 10 and sargramostim SC QD for three days following each vaccine injection. Some patients also receive aldesleukin SC daily from weeks 2-14.
干预措施: laboratory biomarker analysis (Other)
Treatment (vaccine therapy)
Patients receive autologous immunoglobulin idiotype-KLH conjugate vaccine combined with sargramostim SC in weeks 0, 2, 6, and 10 and sargramostim SC QD for three days following each vaccine injection. Some patients also receive aldesleukin SC daily from weeks 2-14.
干预措施: aldesleukin (Biological)
结局指标
主要结局
Toxicities graded using the National Cancer Institute (NCI) Common Toxicity Criteria
时间窗: Up to 2 years
Descriptive statistics will be used to summarize changes from baseline in clinical laboratory parameters for each cohort.
Immune response
时间窗: Up to 2 years
Descriptive statistics will be used to summarize changes from baseline in clinical laboratory parameters for each cohort.
次要结局
未报告次要终点