Clinical trial NCT04975217: Fecal Microbial Transplants for the Treatment of Pancreatic Cancer
Official title: Pilot Study Using Fecal Microbial Transplants in Patients with Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Pancreatic Ductal Adenocarcinoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2021-07-23
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Incidence of adverse events
timeFrame: Up to 30 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Florencia McAllister, MD
role: PRINCIPAL_INVESTIGATOR
References: