粪便微生物移植治疗胰腺癌
在胰腺癌患者中使用粪便微生物移植的试点研究
This early phase I trial examines the safety and effects of fecal microbial transplants in treating patients with pancreatic cancer. scheduled for surgery to remove tumors. Fecal microbial transplant contains the normal microbes found in fecal (stool) material. Giving fecal microbial transplant may help control the disease.
研究概览
地位
条件
详细说明
PRIMARY OBJECTIVE:
I. To assess the safety, tolerability, and feasibility of fecal microbiota transplantation (FMT) in resectable patients with pancreatic ductal adenocarcinoma (PDAC).
SECONDARY OBJECTIVES:
I. To assess changes in gut microbiome of PDAC patients after FMT. II. To assess changes in oral microbiome of PDAC patients after FMT. III. To assess changes in tumor microbiome of PDAC patients after FMT. IV. To determine immunological/molecular changes in the tumor after FMT.
OUTLINE:
Patients undergo FMT during colonoscopy. Patients also receive FMT capsules orally (PO) once weekly (QW) for 4 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care resection of tumor(s).
After completion of study treatment, patients are followed up at 2 weeks and 30, 60, 90, and 180 days after surgery.
研究类型
注册 (估计的)
阶段
- 第一阶段早期
联系人和位置
学习地点
-
-
Texas
-
Houston、Texas、美国、77030
- M D Anderson Cancer Center
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients that are seen at MD Anderson Cancer Center
- Patients with pancreatic ductal adenocarcinoma (PDAC) diagnosis who are expected to have surgery (Whipple)
- Adequate hematological function, defined by white blood cell (WBC) count ≥ 3,000/microL, platelet count ≥75,000/microL, and Hgb ≥ 8 g/dL
- Adequate hepatic function defined by a total bilirubin level ≤ 1.5 × the upper limit of normal (ULN), an AST, level ≤ 2.5 × ULN, and an ALT level ≤ 2.5 × ULN
- Adequate renal function defined by an estimated creatinine clearance >30 mL/min according to the Cockcroft-Gault formula or by a creatinine clearance measurement from a 24-hour urine collection
- Age 18 years and above
- Male or female
- Willingness and ability to sign an informed consent
- Consent and ability to give blood and stool samples
- Consent to undergo a baseline core biopsy and colonoscopy for FMT delivery
- An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
Exclusion Criteria:
- Age younger than 18 years
- Positive GI infection
- Patients with pancreatic cancer Stage T1N0
- Individuals at higher risk of colonization with MDROs
- Patient received antibiotics in the last 48 hours. Patients will be eligible to enroll if antibiotic therapy is discontinued for at minimum 48 hours prior to start of study
- Patients with active viral, bacterial or fungal infection
- History of inflammatory bowel disease, and/or radiation enteritis or colitis
- Pregnant and breastfeeding women
- Women of child-bearing potential who have positive urine or serum pregnancy test or refuse to do pregnancy test
- Has a diagnosis of immunodeficiency
- Peripheral WBC >12 x 10^9/L and/or temperature >38 degrees Celsius
- Subjects with neutropenia (ANC <1500)
- Swallowing dysfunction or known chronic aspiration
- Delayed gastric emptying
- History of intestinal obstruction
- Acute exacerbation of underlying comorbid condition
- Severely immunocompromised patients
- Allergies to drugs included as part of trial (antibiotics, loperamide or laxatives)
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Treatment (FMT, FMT capsules)
Patients undergo FMT during colonoscopy. Patients also receive FMT capsules PO QW for 4 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care resection of tumor(s). |
Ancillary studies Undergo FMT
其他名称：
Given PO
其他名称：
Undergo standard of care resection
其他名称：
Undergo colonoscopy |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incidence of adverse events
大体时间：Up to 30 days after surgery
|
Will be measured by Common Terminology Criteria for Adverse Events, version 5. |
Up to 30 days after surgery
|
合作者和调查者
调查人员
- 首席研究员：Florencia McAllister, MD、M.D. Anderson Cancer Center
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.