Phase II, Multicenter Vaccination of Patients With Chronic Myelogenous Leukemia With a Multivalent Tumor Specific Breakpoint Peptide Vaccine
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Vaccines may make the body build an immune response to kill cancer cells.
PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients who have chronic myelogenous leukemia.
详细描述
OBJECTIVES:
- Determine the safety and immunogenicity of a multivalent tumor-specific breakpoint peptide vaccine in patients with chronic myelogenous leukemia.
- Determine the antileukemic effects of vaccination with these peptides in these patients.
OUTLINE: Patients receive bcr/abl breakpoint peptide vaccine in QS21 adjuvant subcutaneously at rotated sites every 1-3 weeks (on or about days 0, 7, 21, 35, and 56) over 8 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients demonstrating a response by week 10 may receive 3 additional monthly vaccinations initiated within 8 weeks of the fifth dose. Patients demonstrating a response by vaccination 8 may receive 3 additional vaccinations administered at two-month intervals.
Patients are followed at 2 weeks.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study within 2 years.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically proven chronic myelogenous leukemia
- •Must have (9;22) translocation or bcr/abl transcript, and b3a2 breakpoint
- •No accelerated or blastic phase
- •Must be in hematologic remission with peripheral WBC less than 20,000/mm^3
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Karnofsky 70-100%
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •See Disease Characteristics
- •Absolute granulocyte count greater than 1,200/mm^3
- •Platelet count greater than 70,000/mm^3
- •Hemoglobin greater than 9.0 g/dL
- •No active bleeding
- •Bilirubin less than 2.0 mg/dL
- •Lactate dehydrogenase less than 2 times normal
- •Creatinine less than 2.0 mg/dL
- •Cardiovascular:
- •No New York Heart Association class III or IV heart disease
- •No uncontrolled active infection requiring antibiotics
- •No other serious illness
- •No immunodeficiency other than from prior bone marrow transplantation
- •Not pregnant or nursing
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 6 months since prior allogeneic or autologous bone marrow transplantation
- •Prior vaccination with pentavalent peptide at less than study dose level allowed
- •At least 4 weeks since prior immunotherapy other than interferon, donor lymphocyte infusion, or pentavalent vaccine
- •Concurrent interferon allowed
- •Chemotherapy:
- •At least 2 weeks since prior low-dose subcutaneous cytarabine
- •At least 4 weeks since prior chemotherapy other than hydroxyurea
- •No concurrent chemotherapy except hydroxyurea
- •Endocrine therapy:
- •No concurrent corticosteroids
- •Radiotherapy:
- •At least 4 weeks since prior radiotherapy
- •No concurrent radiotherapy
- •No concurrent surgery
- •Concurrent imatinib mesylate allowed
- •No other concurrent systemic therapy
排除标准
- 未提供