ClinicalTrials.gg
Sign In
WithdrawnNCT00493428Updated May 16, 2014

Treatment of Non-Metastatic Hepatocellular Carcinoma in Humans by Increasing Gabaergic Activity: A Pilot Study

A Phase 2 interventional study of Baclofen in Hepatocellular Carcinoma, sponsored by University of Manitoba. Withdrawn at 2 sites in Canada. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2014-05-16.

Sponsored by University of Manitoba · Phase 2, Interventional, and Treatment

Why this study was withdrawn
The study have been stoped because the protocol is going to be modify.
Phase
Phase 2
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study summary

Recent studies indicate that liver cancer cells possess a receptor called the GABA-B receptor that when activated, inhibits the spread of cancer cells in test tubes. One of the drugs that activate these receptors is Baclofen, an agent that was originally developed to treat patients with various neurologic disorders. In this study, patients with recently identified liver cancer will be treated with Baclofen in an attempt to prevent or delay spread of the cancer beyond the liver. The time it takes for liver cancer to spread in the patients will be compared to the results obtained from patients enrolled in previous studies where Baclofen was not used.

Read the detailed description

A total of 47 consecutive patients with radiologic or histologic evidence of non metastatic liver cancer will be enrolled over a 2-4 year period. Subjects will receive oral Baclofen at the manufacturer's suggested maximal dose. Clinical, hematologic, biochemical, and radiologic features of liver function, tumor metastasis and recurrence will be monitored at regular time intervals over a 2 year treatment period. The primary study end point will be the event of interest (time to metastasis or recurrence). Secondary end points will include time to metastasis following recurrence, objective tumor responses (complete, partial and non response), response duration, survival and safety. It is hoped the results of this study will permit liver cancer patients to remain candidates for surgical resection and transplantation longer than would otherwise have been the case.

02

Conditions studied

  • Hepatocellular Carcinoma

Keywords

  • Hepatocellular Carcinoma
  • GABAergic Activity
  • Baclofen
03

In context

Carcinoma, Hepatocellular

3,249 studies on the registry are indexed under Carcinoma, Hepatocellular; 974 are open to participants now.

Browse Carcinoma, Hepatocellular studies →

Lead sponsor

University of Manitoba is the lead sponsor of 554 studies on the registry; 88 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.

Browse University of Manitoba studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • A diagnosis of HCC and no evidence of extra-hepatic metastases on CT/MRI scan of the abdomen, CT of the chest and brain and a negative bone scan.
  • Patients undergoing local therapy (resection, ablation or chemoembolization) and those listed for liver transplantation will not be excluded from participating in the study.
  • Patients with multiple space occupying lesions within the liver (but no evidence of extra-hepatic metastases) will continue to be eligible (the distinction between regenerative nodules and multi-focal HCC versus intra-hepatic metastases can not be made with certainty by presently available techniques).
  • Karnofsky Performance Status (KPS) ≥ 60 %.
  • Age 18 years or greater.
  • Life expectancy of at least 12 weeks.
  • Concomitant Medications
  • Patients should be on stable doses of other medications (no change in dose for two weeks prior to study initiation) when entered into the study.
  • Patient consent must be obtained from all patients prior to entry into the trial.
  • Patients must be accessible for treatment and follow-up i.e. residing within reasonable geographical limits of the study site.

Exclusion criteria

Exclusion Criteria:

  • Any investigational agent within a minimum of 6 weeks prior to study treatment.
  • Pregnant or lactating women; women or men of childbearing potential unless using effective contraception. Patients capable of reproduction must agree to use appropriate methods of contraception during the study and for six months afterwards. Female patients of childbearing potential must have a negative urine pregnancy test within 14 days of study enrollment.
  • Patients whose partners are pregnant.

  • Other serious illness or medical conditions which would not permit the patient to be managed according to the protocol including:

    • History of a psychiatric disorder which would impair the ability to obtain consent or follow-up tumor imaging.
    • Active uncontrolled infection.
  • Any known defect in GABA metabolism or hypersensitivity to Baclofen.
  • Patients with previous organ allograft or taking immunomodulatory drugs.
  • Renal failure not being managed by dialysis.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Interventions

  • DrugBaclofen

    Patients will receive an initial dose of: 5 mg tid to be increased as tolerated to a maximum dose of 20 mg qid. This dose range and schedule reflects that suggested for the drug's muscle relaxant properties in human.

    Also known as: Lioresal,Nu-Baclo

06

What researchers measure

Primary outcomes

  1. Document and Compare the effects of the GABAb receptor agonist Baclofen on the time to develop tumor metastasis in patients with non-metastatic HCC at diagnosis who subsequently undergo surgical resection, ablation or chemoembolization.

    Time frame: 6 years

Secondary outcomes

  1. Document and compare the effects of the GABAb receptor agonist Baclofen on changes in serum tumor markers ( alpha-fetoprotein andd CA19-9 levels) in patients with no-metastatic HCC at diagnosis.

    Time frame: 6 years

07

Study locations

2 sites
  • Liver Unit, Section of Hepatology, Department of Medicine,Health Sciences Centre
    Winnipeg, Manitoba R3E 3P4, Canada
  • Liver Unit, health sciences Centre
    Winnipeg, Manitoba, Canada
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2007, a primary completion of Jan 2011 and a completion of Jan 2011. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 27, 2007
First posted
Jun 28, 2007
Start
Jul 2007
Primary completionActual
Jan 2011
CompletionActual
Jan 2011
Last update
May 16, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 16, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00493428
Lead sponsor
University of Manitoba
First posted
Jun 28, 2007
Start date
Jul 2007
Primary completion
Jan 2011
Completion
Jan 2011
Last update
May 16, 2014

Study contacts

Minuk Y Minuk, MD, FRCPC
principal investigator · University of Manitoba

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in May 2014. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Baclofen

Other studies in this condition

Carcinoma, Hepatocellular →

Other studies from this sponsor

University of Manitoba →

Start the discussion