A Phase I/II Study of PR1 (NSC 698102) Human Leukemia Peptide Vaccine With Montanide ISA 51 (NSC 675756) or Montanide ISA 51 VG (NSC 737063) Adjuvant
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Adverse event DTOX (death or autoimmune toxicity or vascular toxicity at any time) assessed using Common Toxicity Criteria (CTC) version 2.0
研究概览
简要总结
Vaccines made from peptides that are found on leukemia cells may make the body build an immune response and kill cancer cells. Combining vaccine therapy with the immune adjuvant Montanide ISA-51 may be a more effective treatment for chronic myeloid leukemia, acute myeloid leukemia, or myelodysplastic syndrome. This phase I/II trial is studying the side effects and best dose of vaccine therapy when given with Montanide ISA-51 and to see how well they work in treating patients with chronic myeloid leukemia, acute myeloid leukemia, or myelodysplastic syndrome
详细描述
PRIMARY OBJECTIVES:
I. To evaluate both toxicity and immune response efficacy of PR1 peptide (PR1 leukemia peptide vaccine) administered subcutaneously.
SECONDARY OBJECTIVES:
I. To evaluate possible clinical efficacy of PR1 peptide vaccine preparation with Montanide ISA 51 or Montanide ISA 51 VG adjuvant, in high-risk HLA-A2 positive patients with myeloid leukemias.
OUTLINE: This is a phase I dose-escalation study of PR1 leukemia peptide vaccine, followed by a phase II randomized study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be HLA-A2 positive at one allele
- •Patients with CML in chronic phase or early accelerated phase, who are not eligible for BMT or interferon, or have failed standard therapy, or have relapsed after BMT
- •Patients with MDS (FAB subtypes RAEB, and RAEBt) or AML in second or subsequent remission, or AML with a smoldering presentation and who are not candidates for chemotherapy, and who are believed to have a life expectancy of at least 9 weeks
- •ECOG performance status < 3
- •Life expectancy is not severely limited by concomitant illness
- •Serum bilirubin < 3 mg/dl
- •Serum creatinine < 2 mg/dl
- •ALT < 3 x the upper limit of normal
- •No serologic antibody against proteinase 3
- •No known history of Wegener's granulomatosis or other vasculitis
- •FEV, FVC, and DLCO > 50% of predicted, and no symptomatic pulmonary disease
- •Not pregnant; all female patients will have a serum pregnancy test, and only those that test negative will be allowed on study
- •HIV negative
- •No known allergic reaction to Montanide ISA 51 or Montanide ISA 51 VG adjuvant
- •No active uncontrolled infection
- •Patient or representative able to understand the study and consent
- •Patient is not receiving steroids, cyclosporine, or FK-506 for at least 1 month prior to study entry and during study period
- •No concomitant use of interferon or chemotherapy during study period other than hydroxyurea to control cell counts
- •Patients who relapsed within one year of completing the initial vaccination could be retreated with up to 6 additional vaccinations if they remain eligible for treatment according to the original criteria
排除标准
- 未提供
研究组 & 干预措施
Arm I (dose level 1 PR1 leukemia peptide vaccine)
Patients receive dose level 1 of PR1 leukemia peptide vaccine with Montanide ISA-51 SC once every 3 weeks for 18 weeks, for a total of 6 vaccinations. Patients also receive GM-CSF SC with each vaccination.
干预措施: PR1 leukemia peptide vaccine (Biological)
Arm I (dose level 1 PR1 leukemia peptide vaccine)
Patients receive dose level 1 of PR1 leukemia peptide vaccine with Montanide ISA-51 SC once every 3 weeks for 18 weeks, for a total of 6 vaccinations. Patients also receive GM-CSF SC with each vaccination.
干预措施: Montanide ISA 51 VG (Drug)
Arm I (dose level 1 PR1 leukemia peptide vaccine)
Patients receive dose level 1 of PR1 leukemia peptide vaccine with Montanide ISA-51 SC once every 3 weeks for 18 weeks, for a total of 6 vaccinations. Patients also receive GM-CSF SC with each vaccination.
干预措施: sargramostim (Biological)
Arm I (dose level 1 PR1 leukemia peptide vaccine)
Patients receive dose level 1 of PR1 leukemia peptide vaccine with Montanide ISA-51 SC once every 3 weeks for 18 weeks, for a total of 6 vaccinations. Patients also receive GM-CSF SC with each vaccination.
干预措施: laboratory biomarker analysis (Other)
Arm II (dose level 2 PR1 leukemia peptide vaccine)
Patients receive dose level 2 of PR1 leukemia peptide vaccine with Montanide ISA-51 SC once every 3 weeks for 18 weeks, for a total of 6 vaccinations. Patients also receive GM-CSF SC with each vaccination.
干预措施: PR1 leukemia peptide vaccine (Biological)
Arm II (dose level 2 PR1 leukemia peptide vaccine)
Patients receive dose level 2 of PR1 leukemia peptide vaccine with Montanide ISA-51 SC once every 3 weeks for 18 weeks, for a total of 6 vaccinations. Patients also receive GM-CSF SC with each vaccination.
干预措施: Montanide ISA 51 VG (Drug)
Arm II (dose level 2 PR1 leukemia peptide vaccine)
Patients receive dose level 2 of PR1 leukemia peptide vaccine with Montanide ISA-51 SC once every 3 weeks for 18 weeks, for a total of 6 vaccinations. Patients also receive GM-CSF SC with each vaccination.
干预措施: sargramostim (Biological)
Arm II (dose level 2 PR1 leukemia peptide vaccine)
Patients receive dose level 2 of PR1 leukemia peptide vaccine with Montanide ISA-51 SC once every 3 weeks for 18 weeks, for a total of 6 vaccinations. Patients also receive GM-CSF SC with each vaccination.
干预措施: laboratory biomarker analysis (Other)
Arm III (dose level 3 PR1 leukemia peptide vaccine)
Patients receive dose level 3 of PR1 leukemia peptide vaccine with Montanide ISA-51 SC once every 3 weeks for 18 weeks, for a total of 6 vaccinations. Patients also receive GM-CSF SC with each vaccination.
干预措施: PR1 leukemia peptide vaccine (Biological)
Arm III (dose level 3 PR1 leukemia peptide vaccine)
Patients receive dose level 3 of PR1 leukemia peptide vaccine with Montanide ISA-51 SC once every 3 weeks for 18 weeks, for a total of 6 vaccinations. Patients also receive GM-CSF SC with each vaccination.
干预措施: Montanide ISA 51 VG (Drug)
Arm III (dose level 3 PR1 leukemia peptide vaccine)
Patients receive dose level 3 of PR1 leukemia peptide vaccine with Montanide ISA-51 SC once every 3 weeks for 18 weeks, for a total of 6 vaccinations. Patients also receive GM-CSF SC with each vaccination.
干预措施: sargramostim (Biological)
Arm III (dose level 3 PR1 leukemia peptide vaccine)
Patients receive dose level 3 of PR1 leukemia peptide vaccine with Montanide ISA-51 SC once every 3 weeks for 18 weeks, for a total of 6 vaccinations. Patients also receive GM-CSF SC with each vaccination.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Adverse event DTOX (death or autoimmune toxicity or vascular toxicity at any time) assessed using Common Toxicity Criteria (CTC) version 2.0
时间窗: Up to 8 years
Ability of dose
时间窗: Up to 8 years
Regression analyses will be performed.
T cell receptor (TCR) activity
时间窗: Up to 8 years
Regression analyses will be performed.
Clinical response
时间窗: Up to 8 years
Regression analyses will be performed.
Duration of first immune response (IR)
时间窗: Up to 8 years
Will be assessed using logistic regression.
Survival time
时间窗: Up to 8 years
Will be assessed using a Cox model or similar event time model
次要结局
未报告次要终点