NCT01130077已完成1 期
A Pilot Study to Evaluate the Effects of Vaccinations with HLA-A2-Restricted Glioma Antigen-Peptides with Poly-ICLC for Children with Newly Diagnosed Malignant Brain Stem Gliomas, Non-Brainstem High-Grade Gliomas, Recurrent Low-Grade Gliomas or Recurrent High Grade Gliomas
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- James Felker
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Safety: Tolerability during the first two vaccine courses as defined in the protocol.
研究概览
简要总结
The overall objective of this pilot study is to collect immunological and safety data following administration of vaccinations with HLA-A2. This data will be used to decide whether a larger study of clinical efficacy is warranted.
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
- 12 Months 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Patients living outside of North America are not eligible.
- •Presence of metastatic disease for patients in Stratum A, B, D and E. Patients with low grade gliomas (stratum C) may have tumor spread within the CNS.
- •Patients in Stratum F must have tumor spread within the CNS.
- •Patients enrolled in Strata A and B may not have received any prior chemotherapy or anti-glioma therapy of any type other than radiation therapy. Patients enrolled on stratum C must have received at least two prior chemotherapy or biologic therapy regimens and may not have received radiation to the index lesion within 1 year of enrollment. Patients on Strata A, B, E, and F can not have received chemotherapy after radiation therapy was completed.
- •Concurrent treatment or medications (must be off for at least 1 week) including:
- •Interferon (e.g. Intron-A®)
- •Allergy desensitization injections
- •Growth factors (e.g. Procrit®, Aranesp®, Neulasta®)
- •Interleukins (e.g. Proleukin®)
- •Any investigational therapeutic medication
- •Patients must not have a history of, or currently active autoimmune disorders.
- •Use of immunosuppressives within four weeks prior to study entry. Dexamethasone, or other corticosteroid medications, if used in the peri-operative period and/or during radiotherapy, must be tapered (no more than 0.1 mg/kg/day, max 4 mg/day dexamethasone) for at least one week before study registration. Topical corticosteroids are acceptable.
- •Patients with known addiction to alcohol or illicit drugs.
研究组 & 干预措施
HLA Restricted glioma antigen peptides plus Poly ICLC
Experimental
All subjects will receive vaccine plus Poly ICLC will receive 9 injections ( once every 3 weeks)
干预措施: HLA-A2 restricted glioma antigen peptides vaccine (Biological)
HLA Restricted glioma antigen peptides plus Poly ICLC
Experimental
All subjects will receive vaccine plus Poly ICLC will receive 9 injections ( once every 3 weeks)
干预措施: Poly-ICLC (Biological)
结局指标
主要结局
Safety: Tolerability during the first two vaccine courses as defined in the protocol.
时间窗: 6 weeks
Tolerability during the first two vaccine courses as defined in the protocol.
次要结局
- Glioma-associated antigen-specific T-cell response(Monitoring will continue as long as subject remains on study.)
研究者
James Felker
Assistant Professor
University of Pittsburgh
研究点 (1)
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