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Microbiotic Product to Promote Microbiome Health and Improve Chemotherapy Delivery

Primary Purpose

Metastatic Colon Carcinoma, Stage IV Colon Cancer AJCC v8, Stage IVA Colon Cancer AJCC v8

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
NBT-NM108
Sponsored by
Howard S. Hochster, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Colon Carcinoma focused on measuring chemotherapy-induced diarrhea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Robert Wood Johnson University Hospital, HamiltonRecruiting
  • Monmouth Medical CenterRecruiting
  • RWJBarnabas Health - Monmouth Medical Center Southern CampusRecruiting
  • Cooperman Barnabas Medical CenterRecruiting
  • Robert Wood Johnson University HospitalRecruiting
  • Rutgers Cancer Institute of New JerseyRecruiting
  • The Cancer CenterRecruiting
  • Newark Beth Israel Medical CenterRecruiting
  • Robert Wood Johnson University Hospital, SomersetRecruiting
  • Community Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

NM108 Drinks

No Microbiome Support

Arm Description

NBT-NM108 Drinks four times daily before meals and 2 hours after dinner for 56 days. Beginning 5 days before starting chemotherapy, patients receive NBT-NM108 PO QID for 56 days. Patients receive irinotecan-based chemotherapy per standard of care.

No microbiome Patients receive irinotecan-based chemotherapy per standard of care.

Outcomes

Primary Outcome Measures

The number of participants with treatment-related Adverse Events as Assessed by Cancer Therapy Evaluation Program Common Toxicity Criteria (CTCAE) Version 5.0 for toxicity and Adverse Event reporting
The number of participants with treatment-related Adverse Events as Assessed by Cancer Therapy Evaluation Program Common Toxicity Criteria (CTCAE) Version 5.0 for toxicity and Adverse Event reporting. Dose reduction should occur for CTCAE grade 3 or higher toxicity given maximum antidiarrheal support with Imodium and/or Lomotil.
Tumor Response by RECIST v1.1 Criteria
Response and progression will be evaluated in this study using the international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1). Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used for tumor measurements

Secondary Outcome Measures

Full Information

First Posted
March 16, 2022
Last Updated
September 14, 2023
Sponsor
Howard S. Hochster, MD
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1. Study Identification

Unique Protocol Identification Number
NCT05296681
Brief Title
Microbiotic Product to Promote Microbiome Health and Improve Chemotherapy Delivery
Official Title
A Randomized Trial of Microbiotic Product (NBT-NM108) to Promote Microbiome Health and Improve Chemotherapy Delivery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 3, 2022 (Actual)
Primary Completion Date
January 30, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Howard S. Hochster, MD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colon Carcinoma, Stage IV Colon Cancer AJCC v8, Stage IVA Colon Cancer AJCC v8, Stage IVB Colon Cancer AJCC v8, Stage IVC Colon Cancer AJCC v8
Keywords
chemotherapy-induced diarrhea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Participants will be assigned to receive NBT-NM108 or no microbiome support in a 2:1 ratio
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NM108 Drinks
Arm Type
Experimental
Arm Description
NBT-NM108 Drinks four times daily before meals and 2 hours after dinner for 56 days. Beginning 5 days before starting chemotherapy, patients receive NBT-NM108 PO QID for 56 days. Patients receive irinotecan-based chemotherapy per standard of care.
Arm Title
No Microbiome Support
Arm Type
No Intervention
Arm Description
No microbiome Patients receive irinotecan-based chemotherapy per standard of care.
Intervention Type
Drug
Intervention Name(s)
NBT-NM108
Intervention Description
Patients receive irinotecan-based chemotherapy per standard of care.
Primary Outcome Measure Information:
Title
The number of participants with treatment-related Adverse Events as Assessed by Cancer Therapy Evaluation Program Common Toxicity Criteria (CTCAE) Version 5.0 for toxicity and Adverse Event reporting
Description
The number of participants with treatment-related Adverse Events as Assessed by Cancer Therapy Evaluation Program Common Toxicity Criteria (CTCAE) Version 5.0 for toxicity and Adverse Event reporting. Dose reduction should occur for CTCAE grade 3 or higher toxicity given maximum antidiarrheal support with Imodium and/or Lomotil.
Time Frame
Eight weeks
Title
Tumor Response by RECIST v1.1 Criteria
Description
Response and progression will be evaluated in this study using the international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1). Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used for tumor measurements
Time Frame
Imaging for response assessment will be obtained before the initiation of conditioning (no more than 4 weeks prior to apheresis) and at the 6-week follow up time point

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Howard S Hochster, MD
Phone
732-235-2465
Email
howard.hochster@rutgers.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard S Hochster, MD
Organizational Affiliation
Rutgers University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Robert Wood Johnson University Hospital, Hamilton
City
Hamilton
State/Province
New Jersey
ZIP/Postal Code
08690
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Howard S Hochster, MD
Phone
732-235-2465
Email
howard.hochster@rutgers.edu
Facility Name
Monmouth Medical Center
City
Lakewood
State/Province
New Jersey
ZIP/Postal Code
08701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Howard Hochster, MD
Phone
732-235-2465
Email
howard.hochster@rutgers.edu
Facility Name
RWJBarnabas Health - Monmouth Medical Center Southern Campus
City
Lakewood
State/Province
New Jersey
ZIP/Postal Code
08701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Howard S. Hochster
Phone
732-253-5618
Email
howard.hochster@rutgers.edu
Facility Name
Cooperman Barnabas Medical Center
City
Livingston
State/Province
New Jersey
ZIP/Postal Code
07039
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Howard S Hochster, MD
Phone
732-235-2465
Email
howard.hochster@rutgers.edu
Facility Name
Robert Wood Johnson University Hospital
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Howard S Hochster, MD
Phone
732-235-5912
Email
howard.hochster@rutgers.edu
First Name & Middle Initial & Last Name & Degree
Liping Zhao, MD
Phone
(848) 932-5675
Email
liping.zhao@rutgers.edu
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Howard S. Hochster
Phone
732-253-5618
Email
howard.hochster@rutgers.edu
First Name & Middle Initial & Last Name & Degree
Howard S. Hochster
Facility Name
The Cancer Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Howard S Hochster, MD
Phone
732-235-2465
Email
howard.hochster@rutgers.edu
Facility Name
Newark Beth Israel Medical Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Howard Hochster, MD
Phone
732-235-2465
Email
howard.hochster@rutgers.edu
Facility Name
Robert Wood Johnson University Hospital, Somerset
City
Somerville
State/Province
New Jersey
ZIP/Postal Code
08876
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Howard S Hochster, MD
Phone
732-235-2465
Email
howard.hochster@rutgers.edu
Facility Name
Community Medical Center
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08753
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Howard S Hochster, MD
Phone
732-235-2465
Email
howard.hochster@rutgers.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Microbiotic Product to Promote Microbiome Health and Improve Chemotherapy Delivery

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