NCT00547144已完成1 期
A Phase I/II Trial of Intratumoral Dendritic Cell Immunotherapy in Combination With Gemcitabine and Stereotactic Radiosurgery in Unresectable Pancreatic Cancer
George Albert Fisher1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2005年10月最近更新:
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
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- o evaluate the immune response of patients treated with this regimen based on the presence and characterization of tumor-infiltrating white blood cells.
研究概览
简要总结
To determine the safety, feasibility and appropriate dendritic cell dose to vaccinate patients with pancreas cancer
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
- •Patients must have histologically or cytologically confirmed adenocarcinoma of the pancreas. The site of the primary lesion should be confirmed endoscopically, radiologically, or surgically to be in the pancreas.
- •Patients must be deemed unresectable due to involvement of critical vasculature, adjacent organ invasion, presence of metastasis, or other medical condition making surgical resection unfavorable.
- •Patients must have a primary or metastatic lesion measurable in at least one dimension by RECIST criteria within 4 weeks prior to entry of study
- •More than 4 weeks must have elapsed from the time of major surgery or completion of the last dose of chemotherapy, radiation therapy, investigational therapy and patients must adequately recover from these effects.
- •Life expectancy of >3 months.
- •Karnofsky performance status >70%.
- •Patients must have normal organ and marrow functions as defined below: absolute neutrophil count >1,500/mm3 platelets >70,000/mm3 total bilirubin <1.5 mg/dL AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal creatinine within normal institutional limits OR creatinine clearance >60mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
- •albumin > 2.8 mg/dL
- •Patients must have adequate clotting function (platelet > 70k; INR<1.4; PTT<60).
- •Age >18 years.
- •The effects of DCs on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- •No history of autoimmune diseases.
- •Ability to understand the study protocol and a willingness to sign a written informed consent document.
排除标准
- •Patients receiving anticoagulation therapy.
- •Patients who have received prior gemcitabine or radiation therapy to the pancreatic bed
- •Patients receiving any other investigational agents.
- •Patients with known brain metastases will be excluded because of their poor prognosis and because they often develop progressive neurological dysfunction that would confound the evaluation of neurological and other adverse effects.
- •Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements.
- •Patients who test positive for Hepatitis B virus, Hepatitis C virus or HIV.
研究组 & 干预措施
Gemcitabine
Experimental
干预措施: Gemcitabine (Drug)
Gemcitabine
Experimental
干预措施: Dendritic Cell Immunotherapy (Procedure)
结局指标
主要结局
o evaluate the immune response of patients treated with this regimen based on the presence and characterization of tumor-infiltrating white blood cells.
Phase II: To determine the overall response rate for this regimen as determined by radiographic criteria.
Phase I: To establish the maximally tolerated dose (MTD) and dose limiting toxicities (DLT) of intratumoral autologous dendritic cell vaccination in combination with gemcitabine and stereotactic radiosurgery
To determine the time to tumor progression for this regimen.
次要结局
未报告次要终点
研究者
George Albert Fisher
Associate Professor of Medicine
Stanford University
研究点 (1)
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