Fecal Microbial Transplants for the Treatment of Pancreatic Cancer

Pancreatic Ductal Adenocarcinoma Clinical Trial

Official title:

Pilot Study Using Fecal Microbial Transplants in Patients With Pancreatic Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04975217
• Other study ID #: 2020-0788
• Secondary ID: NCI-2021-0348420
• Status: Recruiting
• Phase: Early Phase 1
• Start date: December 14, 2021
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: M.D. Anderson Cancer Center
• Contact: Florencia McAllister, MD
• Phone: 713-563-4743
• Email: fmcallister[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 (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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Pancreatic Ductal Adenocarcinoma

Intervention

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
• Therapeutic Colonoscopy
Undergo colonoscopy

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   M D Anderson Cancer Center