Pilot Study Using Fecal Microbial Transplants in Patients With Pancreatic Cancer
Trial Snapshot
- Phase
- Phase 1
- Status
- Suspended
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- Incidence of adverse events
Study Overview
Brief Summary
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.
Detailed Description
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:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
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).
Intervention: 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).
Intervention: 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).
Intervention: 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).
Intervention: 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).
Intervention: Therapeutic Colonoscopy (Procedure)
Outcomes
Primary Outcomes
Incidence of adverse events
Time Frame: Up to 30 days after surgery
Will be measured by Common Terminology Criteria for Adverse Events, version 5.
Secondary Outcomes
No secondary outcomes reported