Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Adenocarcinoma

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Small Intestinal Adenocarcinoma

Anti-Infective Agents

All Drugs and Chemicals

Antineoplastic Agents

Metronidazole

Pembrolizumab

Vancomycin

Nivolumab

Neomycin

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Anti-Bacterial Agents

Antiprotozoal Agents

Antiparasitic Agents

Enzyme Inhibitors

Patients receive metronidazole PO Q8H on days -14 to -8 and then vancomycin PO Q6H and neomycin PO Q6H on days -8 to -6. Patients then undergo colonoscopic FMT on day -5.

POST-COLONOSCOPIC FMT: Patients receive standard of care pembrolizumab IV over 30 minutes on day 1. Patients also receive fecal microbiota transplantation capsule PO on days 1, 8, and 15 of cycle 1. Beginning in cycle 2, patients receive fecal microbiota transplantation capsule PO on day 1. Cycles repeat every 21 days for up to 6 months in the absence of disease progression or unacceptable toxicity.

Patients receive metronidazole PO Q8H on days -14 to -8 and then vancomycin PO Q6H and neomycin PO Q6H on days -8 to -6. Patients then undergo colonoscopic FMT on day -5.

POST-COLONOSCOPIC FMT: Patients receive standard of care nivolumab IV over 30 minutes on day 1. Patients also receive fecal microbiota transplantation capsule PO on days 1 and 8 of cycles 1-2. Beginning in cycle 4, patients receive fecal microbiota transplantation capsule PO on day 1 of every other cycle. Cycles repeat every 14 days for up to 6 months in the absence of disease progression or unacceptable toxicity.

Biopsy

Fecal Microbiota Transplantation

Fecal Microbiota Transplantation Capsule

Questionnaire Administration

Michael J Overman

This phase II trial studies the effect of fecal microbiota transplant and re-introduction of anti-PD-1 therapy (pembrolizumab or nivolumab) in treating anti-PD-1 non-responders with colorectal cancer that has spread to other places in the body (metastatic). Fecal microbiota transplants contain the normal bacteria and viruses found in fecal (stool) material. Immunotherapy with monoclonal antibodies, such as pembrolizumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving pembrolizumab or nivolumab with fecal microbiota transplants may help to control the disease.

PRIMARY OBJECTIVE:

I. To evaluate the efficacy of pembrolizumab or nivolumab in conjunction with fecal microbiota transplant (FMT) from PD-1 responding mismatch-repair deficiency (dMMR) colorectal cancer (CRC) patients for treatment of PD-1 non-responding dMMR CRC patient.

Fecal Microbiota Transplant and Re-introduction of Anti-PD-1 Therapy (Pembrolizumab or Nivolumab) for the Treatment of Metastatic Colorectal Cancer in Anti-PD-1 Non-responders

Pilot Trial of Fecal Microbiota Transplantation and Re-Introduction of Anti-PD-1 Therapy in dMMR Colorectal Adenocarcinoma Anti-PD-1 Non-Responders

Assessed by Immune-Modified Response Evaluation Criteria in Solid Tumors (iRECIST). Will be summarized by mean, standard error, and 95% confidence interval.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Pancreatic Cancer

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).

Resection

Therapeutic Colonoscopy

Florencia McAllister, MD

Florencia McAllister

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.

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.

Fecal Microbial Transplants for the Treatment of Pancreatic Cancer

Pilot Study Using Fecal Microbial Transplants in Patients With Pancreatic Cancer

Will be measured by Common Terminology Criteria for Adverse Events, version 5.

Immune System Diseases

Graft vs Host Disease

Homologous Wasting Disease

Acute Graft Versus Host Disease

Patients receive fecal microbiota capsules PO QD for 7 days

Patients receive placebo PO QD for 7 days

Placebo

Armin Rashidi

This randomized placebo-controlled double-blind phase II trial tests whether fecal microorganism (microbiota) transplantation prevents severe acute graft versus host disease in adults undergoing allogeneic hematopoietic cell transplantation (HCT). Fecal microbiota transplantation involves receiving processed fecal material orally after allogeneic HCT in order to establish a healthy gut microbiota. Gut microbiota undergoes major alterations during allogeneic HCT because of antibiotic exposures, nutritional changes, and chemotherapy administration. Establishing a healthy gut microbiota via fecal transplantation may help prevent acute graft versus host disease in patients undergoing allogeneic HCT.

OUTLINE: The first 12 patients are assigned to group I, remaining patients are randomized to 1 of 2 groups.

GROUP I: Patients receive fecal microbiota capsules orally (PO) once daily (QD) for 7 days starting at the time of neutrophil engraftment and discontinuation of anti-bacterial antibiotics.

GROUP II: Patients receive placebo PO QD for 7 days starting at the time of neutrophil engraftment and discontinuation of anti-bacterial antibiotics.

After completion of study intervention, patients are followed up monthly until 12 months post-allogeneic HCT.

The first 12 patients are assigned to the treatment group, remaining patients are randomized to treatment or placebo group.

Investigators, treating physicians, staff, and subjects are blinded to study arm assignment (FMT vs. placebo).

Fecal Microbiota Transplantation for the Prevention of Acute Graft Versus Host Disease in Adults Undergoing Allogeneic Hematopoietic Cell Transplantation

Fecal Microbiota Transplantation to Prevent Acute Graft-Versus-Host Disease After Allogeneic Hematopoietic Cell Transplantation

Based on IBMTR criteria and measured as a probability

Death not due to relapse/progression of the underlying hematologic disorder and measured as a probability

Based on a positive stool assay in the consistent clinical setting (e.g. diarrhea) and measured as a probability

Diagnosis based on the NIH Consensus Criteria (PMID: 25529383)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Fecal Microbiota Transplant and Re-introduction of Anti-PD-1 Therapy (Pembrolizumab or Nivolumab) for the Treatment of Metastatic Colorectal Cancer in Anti-PD-1 Non-responders	NCT04729322	Metastatic Colo... Metastatic Smal... Stage IV Colore... Stage IV Small ... Stage IVA Color... Stage IVB Color... Stage IVC Color...	Biopsy Fecal Microbiot... Fecal Microbiot... Metronidazole Neomycin Nivolumab Pembrolizumab Questionnaire A... Vancomycin	18 Years -	M.D. Anderson Cancer Center
Fecal Microbial Transplants for the Treatment of Pancreatic Cancer	NCT04975217	Pancreatic Duct...	Fecal Microbiot... Fecal Microbiot... Questionnaire A... Resection Therapeutic Col...	18 Years -	M.D. Anderson Cancer Center
Fecal Microbial Transplants for the Treatment of Pancreatic Cancer	NCT04975217	Pancreatic Duct...	Fecal Microbiot... Fecal Microbiot... Questionnaire A... Resection Therapeutic Col...	18 Years -	M.D. Anderson Cancer Center
Fecal Microbiota Transplant and Re-introduction of Anti-PD-1 Therapy (Pembrolizumab or Nivolumab) for the Treatment of Metastatic Colorectal Cancer in Anti-PD-1 Non-responders	NCT04729322	Metastatic Colo... Metastatic Smal... Stage IV Colore... Stage IV Small ... Stage IVA Color... Stage IVB Color... Stage IVC Color...	Biopsy Fecal Microbiot... Fecal Microbiot... Metronidazole Neomycin Nivolumab Pembrolizumab Questionnaire A... Vancomycin	18 Years -	M.D. Anderson Cancer Center
Fecal Microbiota Transplantation for the Prevention of Acute Graft Versus Host Disease in Adults Undergoing Allogeneic Hematopoietic Cell Transplantation	NCT06026371	Acute Graft Ver... Hematopoietic a...	Fecal Microbiot... Placebo	18 Years -	Fred Hutchinson Cancer Center
Fecal Microbiota Transplant and Re-introduction of Anti-PD-1 Therapy (Pembrolizumab or Nivolumab) for the Treatment of Metastatic Colorectal Cancer in Anti-PD-1 Non-responders	NCT04729322	Metastatic Colo... Metastatic Smal... Stage IV Colore... Stage IV Small ... Stage IVA Color... Stage IVB Color... Stage IVC Color...	Biopsy Fecal Microbiot... Fecal Microbiot... Metronidazole Neomycin Nivolumab Pembrolizumab Questionnaire A... Vancomycin	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for fecal microbiota transplantation capsule