NCT01902771终止1 期
A Phase I Study of Dendritic Cell Vaccine Therapy With In Situ Maturation for Pediatric Brain Tumors
Edward Ziga2 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2013年9月3日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Rate of Toxicity in Study Participants Receiving Protocol Therapy
研究概览
简要总结
DC vaccine manufactured and partially matured using our standard operating procedures, developed in collaboration with the HGG Immuno Group, then administered through imiquimod treated skin will be safe and feasible in children with refractory brain tumors. This will result in anti-tumor immunity that will prolong survival of subjects treated and results will be consistent with the outcomes found for subjects treated by HGG Immuno Group investigators. Study treatment will correlate with laboratory evidence of immune activation. Correlative studies will also reveal targets in the immune system which can be exploited to improve response for patients on successor trials.
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
- 1 Year 至 29 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: ≥ 1 year and ≤ 29 years
- •Relapse or progression of any central nervous system tumor initially diagnosed before the age of 21 years.
- •Total or subtotal resection of tumor mass, confirmed by assessment by the neurosurgeon and by postoperative MRI scan within 72 hours after surgery. The post-operative assessment should demonstrate residual tumor less than or equal to 2 cm^3 as judged by surgeon or on MRI the tumor should only show linear contrast enhancement at the border of the resection cavity or nodule less than 2 cm^
- •No radiotherapy and/or chemotherapy received for at least 1 month before first DC vaccination is to be administered.
- •No treatment with corticosteroids or salicylates for at least 1 week before first vaccination.
- •Life expectancy ≥ 3 months
- •Written consent by patient or parent(s) (if patient is < 18 years) on an institutional review board (IRB)-approved informed consent form prior to any study-specific evaluation. Assent is required from children as per University of Miami (UM) IRB guidelines. Subject must be capable of understanding the investigational nature, potential risks and benefits of the study and able to provide valid informed consent.
- •Adequate organ function (to be measured at enrollment)
- •Absolute neutrophil count (ANC) ≥750/L
- •Lymphocytes ≥ 500/L
- •Platelets ≥ 75,000/L
- •Hemoglobin ≥ 9 g/dL
- •Aspartate aminotransferase (AST)/Alanine transaminase (ALT) ≤ 2.5 X upper limit of normal (ULN); if liver metastases, ≤ 5 X ULN
- •Serum Creatinine ≤ 1.5 X ULN
- •Total Bilirubin ≤ 3 X ULN
- •Albumin > 2 g/dL
- •Subjects must agree to use adequate method of contraception or abstinence throughout and up to 4 weeks after the study treatment completion.
- •Karnofsky score ≥ 70 or Eastern Cooperative Oncology Group (ECOG) status of 0 or 1.
排除标准
- •Breast feeding females.
- •Any concomitant participation in other therapeutic trials.
- •Virus serology positive for HIV (testing is not required in the absence of clinical suspicion).
- •Documented immunodeficiency or autoimmune disease.
- •Other active malignancies.
- •Refusal to use adequate contraception for fertile patients (females and males) during the study and for 30 days after the last dose of study treatment.
- •Any serious or uncontrolled medical or psychiatric condition that in the opinion of the investigator makes the patient not able to participate in the study.
- •Application of gliadel wafers within the prior 4 months or a plan to place Gliadel wafers at the time of resection for tumor acquisition for study.
结局指标
主要结局
Rate of Toxicity in Study Participants Receiving Protocol Therapy
时间窗: Up to 28 Weeks
Rate of treatment-limiting toxicities (TLT) and/or adverse events in study participants receiving protocol therapy.
Rate of Feasibility of Protocol Therapy in Study Participants
时间窗: Up to 4 Weeks
Rate of feasibility of protocol therapy in study participants. Feasibility refers to clinical feasibility - whether or not the patient can have enough monocytes removed to manufacture Dendritic Cells.
次要结局
- Rate of Prolonged Survival or Prolonged Progression-Free Survival in Study Participants(Up to 24 Months)
- Estimation of the Proportion of Subjects with Recurrent Pediatric Brian Tumors who are able to complete DC Vaccine therapy and DC Vaccine + Lysate Therapy.(Up to 24 months)
- Rate of Measurable Immune Response in Subjects Receiving Protocol Therapy.(Up to 24 months)
- Comparison of clinical parameters of study participants versus associated outcomes for patients on other DC/Imiquimod studies.(Up to 24 Months)
- Identification of Parameters Associated with Poorer Activity of the Vaccine in Study Participants(Up to 24 Months)
研究者
Edward Ziga
Assistant Professor of Clinical Pediatrics
University of Miami
研究点 (2)
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