NCT00030303已完成1 期
A Feasibility And Toxicity Study Of Vaccination With HSP70 For The Treatment Of Chronic Myelogenous Leukemia In Chronic Phase
UConn Health2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2001年1月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Vaccines made from a person's white blood cells may make the body build an immune response to kill cancer cells.
PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have chronic myelogenous leukemia.
详细描述
OBJECTIVES:
- Determine the feasibility of vaccination with autologous heat shock protein 70 in patients with chronic phase chronic myelogenous leukemia.
- Determine the toxicity of this vaccination in these patients.
OUTLINE: Patients undergo leukapheresis to obtain peripheral mononuclear cells (PMNCs). Heat shock protein 70 (HSP70) is derived from the autologous PMNCs. Patients receive HSP70 intradermally once weekly for 8 weeks.
Patients are followed for 2 weeks.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of chronic phase chronic myelogenous leukemia
- •Philadelphia chromosome positive
- •Peripheral blast count no greater than 10%
- •No molecular remission
- •Less than 3 years since initial diagnosis
- •No anticipation of requirement for bone marrow or stem cell transplantation for 6 months
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Hemoglobin at least 10 g/dL
- •Platelet count at least 20,000/mm^3
- •Bilirubin less than 2.0 times upper limit of normal (ULN)
- •Transaminase less than 2.0 times ULN
- •Creatinine less than 2.0 mg/dL
- •Not pregnant
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No significant active infection requiring hospitalization
- •No other serious illness or significant behavioral or psychological problem that would preclude study involvement
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •See Disease Characteristics
- •Prior interferon alfa allowed
- •No concurrent interferon alfa
- •Chemotherapy:
- •Prior cytarabine or other cytotoxic agents allowed
- •No concurrent cytarabine or other cytotoxic agents
- •Concurrent hydroxyurea allowed
- •Endocrine therapy:
- •No concurrent corticosteroid therapy
- •Radiotherapy:
- •Not specified
- •Not specified
- •No concurrent immunosuppressive medications
- •Concurrent imatinib mesylate allowed
排除标准
- 未提供
研究者
研究点 (2)
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