NCT01734564已完成2 期
Phase II Study With Hiltonol and Dendritic Cells in Solid Tumors
Clinica Universidad de Navarra, Universidad de Navarra2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2012年11月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Response rate
研究概览
简要总结
In this phase II study, patients with solid tumors will receive treatment with hiltonol and autologous dendritic cells.
详细描述
In this phase II study, patients with solid tumors will receive treatment with intratumoral hiltonol and two cycles of autologous dendritic cells loaded with autologous tumor and administered subcutaneously. A new cohort will explore the role of radiation therapy, looking for an abscopal effect.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of advanced solid tumors
- •Measurable disease
- •Performance status 0, 1 or
- •Adequate renal, hepatic and bone marrow function
- •Availability of tumor tissue, for maturing dendritic cells
排除标准
- •Clinically relevant diseases or infections.
- •concurrent participation in other clinical trial or administration or other antitumoral treatment
- •Concurrent cancer, with the exceptions allowed by the PI.
- •Pregnant or breast feeding women
- •immunosuppressant treatment
- •known uncontrolled central nervous system metastasis
结局指标
主要结局
Response rate
时间窗: 8-10 weeks
次要结局
- Safety (Common Toxicity Criteria 4.0)(8-10 weeks)
研究者
研究点 (2)
Loading locations...
相似试验
撤回
2 期
Autologous Dendritic Cells Pulsed With Tumor Lysate Antigen Vaccine and Nivolumab in Treating Patients With Recurrent GlioblastomaGiant Cell GlioblastomaGliosarcomaOligodendrogliomaSmall Cell GlioblastomaRecurrent GlioblastomaNCT03014804Jonsson Comprehensive Cancer Center
撤回
2 期
Dendritic Cell-Based Treatment Plus Immunotherapy for the Treatment of Metastatic or Unresectable Triple Negative Breast CancerAnatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8Metastatic Triple-Negative Breast CarcinomaUnresectable Triple-Negative Breast CarcinomaNCT05539365Roswell Park Cancer Institute19
招募中
1 期
Autologous Dendritic Cells, Metronomic Cyclophosphamide and Checkpoint Blockade in Children With Relapsed HGGChildhood GlioblastomaNCT03879512Wuerzburg University Hospital25
终止
2 期
Phase 2 STIR Trial: Haploidentical Transplant and Donor Natural Killer Cells for Solid TumorsOsteosarcomaCNS TumorsRhabdomyosarcomaNeuroblastomaEwing SarcomaNCT02100891Monica Thakar15
撤回
1 期
Intratumoral Dendritic Cell Vaccination Combined With Local Radiotherapy in Patients With Recurrent Lymphoma.LymphomaNCT00637117Baylor Research Institute