Utilization of Microbiome as Biomarkers and Therapeutics in Immuno-Oncology

NCT ID: NCT04264975

Last Updated: 2020-02-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-04
• Study Completion Date: 2023-04-30

Brief Summary

This is an open label, single-center, non-randomized clinical trial on utilization of microbiome as biomarkers and therapeutics in immuno-oncology.

This research consists of two parts:

part 1: development of microbiome biomarkers for immuno-oncology part 2: proof-of-concept trial on the fecal microbiota transplantation in patients who are being treated with immunotherapy for advanced solid tumor

Conditions

Solid Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fecal microbiota transplantation

Fecal microbiota transplantation in patients who have advanced solid cancer with primary (group 1) or secondary resistance (group 2) to immuno-oncology

Group Type: EXPERIMENTAL

fecal microbiota transplantation

Intervention Type: PROCEDURE

Fecal microbiota transplantation (FMT) is the administration of a solution of fecal matter from a donor into the intestinal tract of a recipient in order to directly change the recipient's microbial composition and confer a health benefit

Interventions

fecal microbiota transplantation

Fecal microbiota transplantation (FMT) is the administration of a solution of fecal matter from a donor into the intestinal tract of a recipient in order to directly change the recipient's microbial composition and confer a health benefit

Intervention Type: PROCEDURE

Other Intervention Names

FMT

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 19 years old

2. Eastern Cooperative Oncology Group performance status 0-2

3. Measurable or evaluable lesion(s) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

1. Patients who have partial or complete response to immunotherapy at the time of stool donation

2. No history of exposure to HIV or hepatitis virus within the previous 12 months

3. No history of international travel within previous 6 months to areas of high risk of travelers' diarrhea

4. No current communicable disease

5. No household members with active gastrointestinal infection

6. No history of inflammatory bowel disease

7. No recent intake of potential allergenic foods that are known to cause hypersensitivity in a recipient (such as peanut)

1. Patients without contraindications for colonoscopy such as suspected bowel perforation, acute diverticulitis, or fulminant colitis

2. Patients who have disease progression to immunotherapy as one of the following two patterns:

2-1) Patients who have disease progression due to primary resistance to immunotherapy

2-2) Patients who have disease progression following disease stabilization due to secondary resistance to immunotherapy

Exclusion Criteria

1. A history of other cancers requiring treatment within the recent 3 years (excepting treated basal or squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, breast, or stomach)

2. A history of active primary immunodeficiency

3. Active infection including tuberculosis or Human Immunodeficiency Virus (HIV)

4. Autoimmune disease (excepting type 1 diabetes mellitus, hypothyroidism requiring hormone replacement therapy only, skin disease not requiring systemic therapy (such as vitiligo, psoriasis or alopecia)

5. Patients who are receiving immunosuppressive medications (excepting topical steroids, systemic steroid ≤10 mg/day prednisone or equivalents, or a brief course of steroids for prophylaxis (e.g., hypersensitivity reaction)

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part 2: proof-of-concept trial on the fecal microbiota transplantation in patients who are being treated with immunotherapy for solid cancers

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Sook Ryun Park

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sook Ryun Park, M.D, Ph D

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center, Ulsan University of College of Medicine

Locations

Asan Medical Center

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Sook Ryun Park, M.D, Ph D

Role: CONTACT

srpark@amc.seoul.kr

+82-2-3010-3210

Facility Contacts

Sook Ryun Park, M.D, Ph D

Role: primary

srpark@amc.seoul.kr

+82-2-3010-3206

Other Identifiers

2018-0608

Identifier Type: -

Identifier Source: org_study_id