NCT00937300撤回1 期
T-cell Based Immunotherapy for Treatment of Patients Squamous Cell Carcinoma in the Oral Cavity. A Pilot Study.
Inge Marie Svane2 个研究点 分布在 1 个国家开始时间: 2009年6月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- toxicity
研究概览
简要总结
The aim of this study is to investigate the toxicity and immune response of therapy with tumor infiltrating lymphocytes as adjuvant treatment for head and neck cancer after primary operation and radiotherapy.
Patient will receive a single treatment consisting of conditioning chemotherapy for seven days (cyclophosphamide for two days and fludarabine for five days), intravenous infusion of high number of in vitro expanded tumor infiltrating lymphocytes followed by two weeks with daily low-dose interleukine-2. Patients will be evaluated for toxicity and immune response.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histological proven squamous cell carcinoma T3 or more in the oral cavity planned for primary surgery. Performance Status 0 to
- •Acceptable CBC and blood chemistry results. Acceptable organ functions.
排除标准
- •Patients with a history of any other malignancies less than five years ago. Brain metastases. Other significant illness including severe allergy, asthma, DM, angina pectoris, congestive heart failure, chronic infections, or active autoimmune disease. Treatment with immune suppressive drugs, experimental drugs, or antineoplastic drugs.
结局指标
主要结局
toxicity
时间窗: week 0 to 20
次要结局
- immune response(week 0 to 20)
研究者
Inge Marie Svane
Professor
Herlev Hospital
研究点 (2)
Loading locations...
相似试验
已完成
1 期
T-cell Based Immunotherapy for of MelanomaMelanomaNCT00937625Inge Marie Svane31
招募中
1 期
Immunotherapy for the Treatment of Advanced Solid TumorRecurrence TumorMetastatic CancerSolid TumorNCT03658785Tongji Hospital40
终止
1 期
A Study of Immunotherapy With TIL (Tumor Infiltrating Lymphocytes) in Combination With Intra-tumoral Injections of Interferon Gamma-adenovirus (Ad-IFNg) in Patients With Stage IIIc or Stage IV Metastatic Melanoma (AJCC)(Protocol TIL-Ad-INFg)Metastatic MelanomaNCT01082887Nantes University Hospital18
招募中
早期 1 期
TCR-T Cells in the Treatment of Advanced Pancreatic CancerPancreatic CancerNCT06054984Ruijin Hospital18
已完成
2 期
Study to Evaluate Safety and Antitumor Activity of Lete-Cel (GSK3377794) in HLA-A2+ Participants With NY-ESO-1 Positive Previously Treated Advanced (Metastatic or Unresectable) Synovial Sarcoma or Myxoid/Round Cell LiposarcomaNeoplasmsNCT06703346USWM CT, LLC82