Back to Trials
NCT05296681PHASE2Recruiting

Microbiotic Product to Promote Microbiome Health and Improve Chemotherapy Delivery

Howard S. Hochster, MD

Start Date

5/3/2022

Completion Date

6/1/2027

Summary

This phase II trial tests whether NBT-NM108 works in reducing chemotherapy-induced diarrhea in patients with colon cancer that has spread to other places in the body (metastatic). Irinotecan is one of the most used medicine for colon cancer, but it leads to diarrhea in most patients receiving it and among some of them, severe diarrhea can occur. NBT-NM108 is a high dietary fiber formula that is developed based on research findings that have shown that high fiber diets can help maintain healthy bacteria in the gut and improve gut function. Giving NBT-NM108 to patients with colon cancer receiving chemotherapy may help relieve or lessen diarrhea symptoms and lead to improved tolerance of the chemotherapy drug, irinotecan.

Detailed Description

PRIMARY ENDPOINT: Dose Intensity of Irinotecan administered (mg/m2/week) SECONDARY ENDPOINTS: 1. Reduction in % Patients Needing Dose Modification for Diarrhea 2. Toxicity Grade of diarrhea 3. Response Rate 4. Time to Progression-free survival EXPLORATORY ENDPOINTS: 1. 16S rRNA gene sequencing to reveal changes of the gut microbiota including institution of foundation guilds and restoration of healthy microbiome 2. Short chain fatty acids analysis (promotion of acetic and butyric acid production) 3. Markers for gut inflammation such as fecal lipocalin 2 4. Gut barrier function test to see if the restoration of healthier gut microbiota would improve gut barrier function.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria * Biopsy proven and metastatic colon cancer * Candidate for Second-line or later line therapy with irinotecan-based chemotherapy regimen with starting dose of irinotecan at 180 mg/m2 q2w. Participants who have had prior irinotecan will be eligible if they are off irinotecan for at least three months and stools have returned to baseline consistency. * Performance Status (PS) 0-1 * Lab values as acceptable for trials: Absolute Neutrophil Count( ANC) \>1500/uL; Creatinine \< 1.5 x Upper Limit of Normal (ULN); Transaminases \< 5x ULN; Bilirubin \< 1.5 x ULN; Albumin \> 3.0 g/dL * No known UGTA1A\* genotype Exclusion Criteria * Grade two diarrhea or greater (4-6 movements per day over baseline) * Inability to take oral supplements * Current antibiotic therapy * Baseline grade 3-4 diarrhea Participants with grade two diarrhea should undergo stool evaluation with stool test for bacteria (Salmonella, Shigella, Campylobacter, Yersinia Mycobacterium), bacterial toxin (Clostridium difficile), ova and parasites (Giardia, Entamoeba, Isospora, Cyclospora, Cryptosporidium, Microsporidium), or viruses (Cytomegalovirus), associated with an ongoing active infection and diarrhea. They will be eligible if this evaluation shows no infection. * History of the following infections and/or disease which could lead to diarrhea: * History of prior positive gastrointestinal biopsy, gastrointestinal culture, or stool test for bacteria (Salmonella, Shigella, Campylobacter, Yersinia, Mycobacterium), bacterial toxin (Clostridium difficile), ova and parasites (Giardia, Entamoeba, Isospora, Cyclospora, Cryptosporidium, Microsporidium), or viruses (Cytomegalovirus), associated with an ongoing active infection and diarrhea unless fully treated with at least three months normal stool. * History of ulcerative colitis, Crohn's disease, celiac sprue (gluten-enteropathy), chronic pancreatitis, malabsorption, or any other gastrointestinal disease associated with diarrhea.

Interventions

DRUG

NBT-NM108

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Metastatic Colon CarcinomaStage IV Colon Cancer AJCC v8Stage IVA Colon Cancer AJCC v8Stage IVB Colon Cancer AJCC v8Stage IVC Colon Cancer AJCC v8

Locations

Robert Wood Johnson University Hospital, Hamilton

Hamilton, New Jersey 08690

United States

Monmouth Medical Center

Lakewood, New Jersey 08701

United States

RWJBarnabas Health - Monmouth Medical Center Southern Campus

Lakewood, New Jersey 08701

United States

Cooperman Barnabas Medical Center

Livingston, New Jersey 07039

United States

Robert Wood Johnson University Hospital

New Brunswick, New Jersey 08901

United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey 08903

United States

The Cancer Center

Newark, New Jersey 07103

United States

Newark Beth Israel Medical Center

Newark, New Jersey 07112

United States

Robert Wood Johnson University Hospital, Somerset

Somerville, New Jersey 08876

United States

Community Medical Center

Toms River, New Jersey 08753

United States