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.
Full Title of Study: “Pilot Study Using Fecal Microbial Transplants in Patients With Pancreatic Cancer”
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: December 31, 2023
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.
- 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
Arms, Groups and Cohorts
- 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).
Clinical Trial Outcome Measures
- Incidence of adverse events
- Time Frame: Up to 30 days after surgery
- Will be measured by Common Terminology Criteria for Adverse Events, version 5.
Participating in This Clinical Trial
- Patients that are seen at MD Anderson Cancer Center – Patients with pancreatic ductal adenocarcinoma (PDAC) diagnosis who are expected to have surgery (whipple) – Patient should have normal levels of blood cell count (CBC) differential and CBC chemistry test results – White blood cell (WBC) count >= 3,000/microL – Platelet count >= 75,000/microL – Hemoglobin (Hgb) >= 8 g/dL – Total bilirubin level =< 1.5 x the upper limit of normal (ULN) – An aspartate aminotransferase (AST) level =< 2.5 x ULN – An alanine aminotransferase (ALT) level =< 2.5 x ULN – Estimated creatinine clearance > 30 mL/min according to the Cockcroft-Gault formula or by a creatinine clearance measurement from a 24-hour urine collection – Between ages 18-70 – 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 gastrointestinal (GI) infection – Patients with pancreatic cancer stage T1N0 – Individuals at higher risk of colonization with multi-drug resistant organisms (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 (absolute neutrophil count [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 ingredients generally recognized as safe
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 70 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- M.D. Anderson Cancer Center
- Provider of Information About this Clinical Study
- Overall Official(s)
- Florencia McAllister, Principal Investigator, M.D. Anderson Cancer Center
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