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

NCT00493428 | Withdrawn Phase 2

• 1 other identifier: B2006:156
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma; GABAergic Activity; Baclofen

Outcome Measures

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.

  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.

  6 years

Interventions

Baclofen DRUG

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (2)

Liver Unit, Section of Hepatology, Department of Medicine,Health Sciences Centre

Winnipeg, Manitoba, R3E 3P4, Canada

Location

Liver Unit, health sciences Centre

Winnipeg, Manitoba, Canada

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Baclofen

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Minuk Y Minuk, MD, FRCPC

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 27, 2007
• First Posted: June 28, 2007
• Study Start: July 1, 2007
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: May 16, 2014

Record last verified: 2014-05

Locations

CA (2)