Vancomycin in Patients With Unresectable Fibrolamellar Hepatocellular Carcinoma (FLC) Oral
Status:
Withdrawn
Trial end date:
2021-12-31
Target enrollment:
Participant gender:
Summary
Background:
Fibrolamellar Hepatocellular Carcinoma (FLC) is a rare liver cancer. It most often occurs in
young people who have no history of liver disease. Unresectable FLC most often does not
improve with surgery. Researchers think gut bacteria may affect liver cancer control. They
want to see if a drug that controls a type of bacteria can help.
Objective:
To test if vancomycin is safe and tolerable for and can treat people with unresectable FLC.
Eligibility:
People ages 18 and older with FLC that isn t responsive to treatment
Design:
Participants will be screened with a medical history, physical exam, blood and urine tests,
and CT or MRI scans. They will provide a tumor sample: If they do not have one, they will
have a biopsy.
Participants will take vancomycin 3 times a day. They will take the drug by mouth. They will
take the drug in 28-day cycles. They will take the drug daily for the first 3 weeks. They
will not take the drug the last week.
Participants will keep a medication diary.
Participants will have blood and urine tests each cycle. They may provide stool samples.
Participants will have a biopsy before they start treatment. Then they will have one on day 1
of cycle 2.
Participants will have scans on day 1 of cycle 2. Then they will have scans about every 8
weeks.
Participants will continue treatment until their cancer gets worse or they can no longer
tolerate the side effects.
Participants will have a follow-up visit about a month after they finish treatment. Then they
will be followed every 6 months by phone or email.