RecruitingEarly Phase 1NCT04975217

Fecal Microbial Transplants for the Treatment of Pancreatic Cancer

Pilot Study Using Fecal Microbial Transplants in Patients With Pancreatic Cancer

Sponsor

M.D. Anderson Cancer Center

Enrollment

10 participants

Start Date

Dec 14, 2021

Study Type

INTERVENTIONAL

Conditions

Pancreatic Ductal Adenocarcinoma

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria11

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 Criteria18

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)