Using fecal microbial transplants to treat pancreatic cancer
Pilot Study Using Fecal Microbial Transplants in Patients With Pancreatic Cancer
This study is testing whether fecal microbial transplants can help patients with pancreatic cancer who are going to have surgery by looking at how safe and effective the treatment is.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT04975217 on ClinicalTrials.gov |
What this trial studies
This early phase I trial investigates the safety and effects of fecal microbial transplants (FMT) in patients with resectable pancreatic ductal adenocarcinoma (PDAC) scheduled for surgery. The study aims to assess the tolerability and feasibility of FMT, as well as its impact on the gut, oral, and tumor microbiomes. Patients will receive FMT during a colonoscopy and take FMT capsules weekly for four weeks, followed by standard surgical resection of tumors. Participants will be monitored for changes in their microbiomes and immunological responses after the treatment.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with pancreatic ductal adenocarcinoma who are expected to undergo surgical resection.
Not a fit: Patients with advanced pancreatic cancer not eligible for surgery or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for patients with pancreatic cancer by enhancing their immune response and potentially controlling disease progression.
How similar studies have performed: While fecal microbial transplants have shown promise in other conditions, this specific application for pancreatic cancer is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Florencia McAllister, MD — M.D. Anderson Cancer Center
- Study coordinator: Florencia McAllister, MD
- Email: fmcallister@mdanderson.org
- Phone: 713-563-4743
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.