Pilot Study Using Fecal Microbial Transplants in Patients With Pancreatic Cancer
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Incidence of adverse events
研究概览
简要总结
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.
详细描述
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:
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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).
干预措施: Fecal Microbiota Transplantation (Procedure)
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).
干预措施: Fecal Microbiota Transplantation Capsule (Drug)
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).
干预措施: Questionnaire Administration (Other)
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).
干预措施: Resection (Procedure)
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).
干预措施: Therapeutic Colonoscopy (Procedure)
结局指标
主要结局
Incidence of adverse events
时间窗: Up to 30 days after surgery
Will be measured by Common Terminology Criteria for Adverse Events, version 5.
次要结局
未报告次要终点