Fecal Microbial Transplants for the Treatment of Pancreatic Cancer

Early Phase 1

Recruiting

• Conditions: Pancreatic Ductal Adenocarcinoma
• Interventions: Procedure: Fecal Microbiota Transplantation; Drug: Fecal Microbiota Transplantation Capsule; Other: Questionnaire Administration; Procedure: Resection; Procedure: Therapeutic Colonoscopy

• Registration Number: NCT04975217
• Lead Sponsor: M.D. Anderson Cancer Center

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:

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.

Study Timeline

• Study First Submitted: 2021-05-25
• Study First Submitted QC: 2021-07-14
• Study First Posted: 2021-07-23
• Study Start: 2021-12-14
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-21
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (FMT, FMT capsules)	Therapeutic Colonoscopy	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).
Treatment (FMT, FMT capsules)	Questionnaire Administration	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).
Treatment (FMT, FMT capsules)	Fecal Microbiota Transplantation	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).
Treatment (FMT, FMT capsules)	Fecal Microbiota Transplantation Capsule	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).
Treatment (FMT, FMT capsules)	Resection	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).

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events	Up to 30 days after surgery	Will be measured by Common Terminology Criteria for Adverse Events, version 5.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States