Pilot Study Using Fecal Microbial Transplants in Patients With Pancreatic Cancer
M.D. Anderson Cancer Center
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.
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: Patients undergo FMT during colonoscopy. Patients also receive FMT capsules orally (PO) once weekly…
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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 f…
Interventions
- ProcedureFecal Microbiota Transplantation
Undergo FMT
- DrugFecal Microbiota Transplantation Capsule
Given PO
- OtherQuestionnaire Administration
Ancillary studies
- ProcedureResection
Undergo standard of care resection
- ProcedureTherapeutic Colonoscopy
Undergo colonoscopy
Location
- M D Anderson Cancer CenterHouston, Texas