Treatment of Non-Metastatic Hepatocellular Carcinoma in Humans by Increasing Gabaergic Activity: A Pilot Study
Information source: University of Manitoba
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatocellular Carcinoma
Intervention: Baclofen (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: University of Manitoba Official(s) and/or principal investigator(s):
Minuk Y Minuk, MD, FRCPC, Principal Investigator, Affiliation: University of Manitoba
Overall contact:
Vivian A Schutt, MD, Phone: 204-977-5619, Email: vschutt@hsc.mb.ca
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.
Clinical Details
Official title: Treatment of Non-Metastatic Hepatocellular Carcinoma in Humans by Increasing Gabaergic Activity: A Pilot Study
Study design: Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: 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.
Secondary outcome: 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.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
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:
- 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.
Locations and Contacts
Vivian A Schutt, MD, Phone: 204-977-5619, Email: vschutt@hsc.mb.ca
Liver Unit, Section of Hepatology, Department of Medicine,Health Sciences Centre, Winnipeg, Manitoba R3E 3P4, Canada; Recruiting
Vivian A Schutt, MD, Phone: 204-977-5619, Email: vschutt@hsc.mb.ca
Carla Franklin, RN, Phone: 204-977-5618, Email: cfranklin@hsc.mb.ca
Gerald Y Minuk, MD,FRCPC, Principal Investigator
Julia Uhanova, MD, Sub-Investigator
Liver Unit, health sciences Centre, Winnipeg, Manitoba, Canada; Recruiting
Vivian A Schutt, MD, Phone: 204-977-5693, Email: vschutt@hsc.mb.ca
Carla Franklin, Nurse, Phone: 977-5618, Email: cfranklin@hsc.mb.ca
Additional Information
Starting date: July 2007
Ending date: July 2013
Last updated: June 6, 2008
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