Fecal Microbial Transplants For The Treatment Of Pancreatic Cancer

Study Overview

Fecal Microbial Transplants for the Treatment of Pancreatic Cancer

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.

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.

Pancreatic Ductal Adenocarcinoma

PROCEDURE: Fecal Microbiota Transplantation
DRUG: Fecal Microbiota Transplantation Capsule
OTHER: Questionnaire Administration
PROCEDURE: Resection
PROCEDURE: Therapeutic Colonoscopy

2020-0788
NCI-2021-03484 (REGISTRY Identifier) (REGISTRY: CTRP (Clinical Trial Reporting Program))
2020-0788 (OTHER Identifier) (OTHER: M D Anderson Cancer Center)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2021-05-25	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-11-19
First Submitted that Met QC Criteria 2021-07-14	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-11-21
First Posted (ACTUAL) 2021-07-23	Results First Posted N/A	Last Verified 2024-11

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: 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).	PROCEDURE: Fecal Microbiota Transplantation Undergo FMT DRUG: Fecal Microbiota Transplantation Capsule Given PO OTHER: Questionnaire Administration Ancillary studies PROCEDURE: Resection Undergo standard of care resection PROCEDURE: Therapeutic Colonoscopy Undergo colonoscopy

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: 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).

PROCEDURE: Fecal Microbiota Transplantation

Undergo FMT

DRUG: Fecal Microbiota Transplantation Capsule

Given PO

OTHER: Questionnaire Administration

Ancillary studies

PROCEDURE: Resection

Undergo standard of care resection

PROCEDURE: Therapeutic Colonoscopy

Undergo colonoscopy

Primary Outcome Measures	Measure Description	Time Frame
Incidence of adverse events	Will be measured by Common Terminology Criteria for Adverse Events, version 5.	Up to 30 days after surgery

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Florencia McAllister, MD

Phone Number: 713-563-4743

Email: fmcallister@mdanderson.org

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Florencia McAllister, MD, M.D. Anderson Cancer Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record