Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-01-03 @ 3:32 AM
Study NCT ID:
NCT04025567
Status:
WITHDRAWN
Last Update Posted:
2020-03-16
First Post:
2019-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vancomycin in Patients With Unresectable Fibrolamellar Hepatocellular Carcinoma (FLC) Oral
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
Phase II Study of Oral Vancomycin in Patients With Unresectable Fibrolamellar Hepatocellular Carcinoma (FLC)
Status:
WITHDRAWN
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
slow/insufficient accrual.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
Background:
* Fibrolamellar hepatocellular carcinoma (FLC) is a rare liver cancer (0.5-9% of primary liver cancers), which affects younger age groups and is not associated with underlying liver disease or elevated serum alpha fetoprotein (AFP) levels.
* Surgery, either liver resection (LR) or liver transplantation (LT), is the only potentially curative treatment for FLC patients with resectable disease. Disease recurrence after complete resection is high (33-100%). In patients with unresectable disease, median survival is less than 12 months; with no patient expected to survive beyond 5 years.
* The role of systemic chemotherapy and radiotherapy is poorly defined, and has been reported to have only a modest or no therapeutic effect. To date no targeted therapy has been shown to be of any value in FLC.
* In mouse models, oral vancomycin alters gut commensal bacteria thereby inducing a liver-selective anti-tumor effect by increasing hepatic CXCR6+ NKT cells via increased CXCL16 expression of liver sinusoidal endothelial cells.
Objective:
-To evaluate the effect of oral vancomycin therapy on the relative CXCR6 gene expression levels in the liver in paired pre- and on-treatment biopsy samples from hepatic lesions in patients with unresectable FLC
Eligibility:
* Histologically confirmed FLC, not amenable to potentially curative resection, transplantation or ablation.
* Liver lesion measurable by RECIST criteria, accessible for biopsy.
* Age greater than or equal to 18 years
* ECOG performance status less than or equal to 2
* Acceptable renal and normal liver function.
* Willingness to undergo pre- and on-treatment biopsies of liver tumor.
Design:
* This is a phase II study of oral vancomycin in patients with unresectable FLC.
* Up to 14 patients will be treated with oral vancomycin 500 mg tid daily (1,500 mg total daily dose) from days 1 to 21, in a 28-day cycles. After completion of the first cycle, initiation of concurrent treatment will be allowed. Patients will receive oral vancomycin until off treatment criteria are met.
* Patients will be evaluated for toxicity every 4 weeks by CTCAE v5.0, and for response at the end of the first cycle and thereafter every 8 (+/-3) weeks by RECIST 1.1.
* Fibrolamellar hepatocellular carcinoma (FLC) is a rare liver cancer (0.5-9% of primary liver cancers), which affects younger age groups and is not associated with underlying liver disease or elevated serum alpha fetoprotein (AFP) levels.
* Surgery, either liver resection (LR) or liver transplantation (LT), is the only potentially curative treatment for FLC patients with resectable disease. Disease recurrence after complete resection is high (33-100%). In patients with unresectable disease, median survival is less than 12 months; with no patient expected to survive beyond 5 years.
* The role of systemic chemotherapy and radiotherapy is poorly defined, and has been reported to have only a modest or no therapeutic effect. To date no targeted therapy has been shown to be of any value in FLC.
* In mouse models, oral vancomycin alters gut commensal bacteria thereby inducing a liver-selective anti-tumor effect by increasing hepatic CXCR6+ NKT cells via increased CXCL16 expression of liver sinusoidal endothelial cells.
Objective:
-To evaluate the effect of oral vancomycin therapy on the relative CXCR6 gene expression levels in the liver in paired pre- and on-treatment biopsy samples from hepatic lesions in patients with unresectable FLC
Eligibility:
* Histologically confirmed FLC, not amenable to potentially curative resection, transplantation or ablation.
* Liver lesion measurable by RECIST criteria, accessible for biopsy.
* Age greater than or equal to 18 years
* ECOG performance status less than or equal to 2
* Acceptable renal and normal liver function.
* Willingness to undergo pre- and on-treatment biopsies of liver tumor.
Design:
* This is a phase II study of oral vancomycin in patients with unresectable FLC.
* Up to 14 patients will be treated with oral vancomycin 500 mg tid daily (1,500 mg total daily dose) from days 1 to 21, in a 28-day cycles. After completion of the first cycle, initiation of concurrent treatment will be allowed. Patients will receive oral vancomycin until off treatment criteria are met.
* Patients will be evaluated for toxicity every 4 weeks by CTCAE v5.0, and for response at the end of the first cycle and thereafter every 8 (+/-3) weeks by RECIST 1.1.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 19-C-0125 | None | None | View |