This early phase I trial examines the safety and feasibility of fecal microbial transplants (FMT) in pancreatic cancer patients. We plan to perform a prospective pilot study in 10 patients with resectable pancreatic cancer who will receive FMT 4 weeks before surgery, during the typical window period that patients are prepared and scheduled for surgery. Stool and oral samples will be collected pre-FMT, at weekly FMT, post- FMT, prior to the Whipple Surgery for 16s sequencing to confirm the changes in the gut and oral microbiome induced by the FMT into PDAC patients. Tumor tissue samples will be collected pre-FMT and at the time of surgery for 16S analysis to examine the changes in the tumor microbiome with FMT from healthy controls. In-depth analysis of the changes in the microbial and immunological components of the pancreatic tumors induced in patients by FMT from healthy controls will inform us on the value of FMT to modulate the gut, oral and tumor microbiome. These changes will ultimately result in modulation of the tumor microenvironment inducing immune activation, which will constitute the basis for more extensive future efficacy studies in pancreatic cancer patients, likely in combination with other strategies not efficacious as single agents.
Additional locations may be listed on ClinicalTrials.gov for NCT04975217.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Active
Contact: Florencia McAllister
Phone: 713-563-4743
PRIMARY OBJECTIVE:
I. To assess the safety, tolerability, and feasibility of fecal microbiota transplantation (FMT) in resectable patients with pancreatic cancer.
SECONDARY OBJECTIVES:
I. To assess changes in gut microbiome of pancreatic cancer patients after FMT.
II. To assess changes in oral microbiome of pancreatic cancer patients after FMT.
III. To assess changes in tumor microbiome of pancreatic cancer patients after FMT.
IV. To determine immunological/molecular changes in the tumor after FMT.
V. To assess differences in gut, oral and tumor microbiome and immunological/molecular changes among the patients who received FMT during the study and resectable patients with pancreatic cancer who did not receive FMT.
OUTLINE:
Patients receive FMT during colonoscopy. Patients also receive FMT capsules orally (PO) once weekly (QW) for 2 weeks prior to standard of care (SOC) resection in the absence of disease progression or unacceptable toxicity. Patients also undergo biopsy on study and blood sample collection throughout the study.
After completion of study treatment, patients are followed up at 2 weeks and 30, 60, 90, and 180 days after surgery.
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorFlorencia McAllister
