A trial of clofazimine in Lipiodol injection in patients with inoperable Hepatocellular carcinoma

Phase 1

Completed

• Conditions: Hepatocellular Carcinoma; Cancer - Liver

• Registration Number: ACTRN12607000172404
• Lead Sponsor: Progen Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-03-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. confirmed diagnosis of progressive unresectable hepatocellular carcinoma.2. measurable disease or elevated tumour markers.3. Lipiodol avid tumour.4. Eastern Cooperative Oncology Group Performance Scale 0-2. 5. Voluntary written Informed consent. 6. liver function tests stable within the previous 4 weeks. 7. Patent hepatic artery and portal vein (demonstrated by angiography with in the previous 4 weeks).

Exclusion Criteria

1. Clinically significant non- malignant disease.2. Prior therapy for the primary cancer in the previous 4 weeks (including lipiodol injection).3. Major surgery within the past 4 weeks.4. hepatic encephalopathy or coagulopathy (INR greater than 2)5. Variceal bleeding in the previous 4 weeks6. women who are pregnant or breastfeeding.7.History of allergy and or hypersensitivity to iodine, Lipiodol or clofazimine.8. elevated liver function tests greater than 10 times normal9. uncontrolled infection in the past 4 weeks.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the maximum tolerated dose of clofazimine in lipiodol injection as a single injection. The maximum tolerated dose will be determined as the dose level below the dose where a drug related toxicitiy/dose limiting toxicity occurs in 2 or more patients in a cohort and is defined as a grade 3 non haematological toxicity or grade 4 haematological toxicity considered to be possibly/probably or certainly related to the study drug.[Assessments will occur on the day of treatment and on days 2, 3, 4, 7, 14, 21 and 28 post the treatment.];Patients will be assessed for safety and tolerability for weeks post the injection. [Assessments will occur on the day of treatment and on days 2, 3, 4, 7, 14, 21 and 28 post the treatment.]

Secondary Outcome Measures

Name	Time	Method
2. To assess the pharmacokinetics of clofazimine in lipiodol injection administered via intrahepatic arterial injection. [Blood will be drawn for pharmacokinetic studies at the following time points: immediately before the study drug is administered , at 1 and 4 hours and day 2, 3, 4, 7, 14, 21 and 28 post study drug administration.];1. to assess safety and tolerability of intrahepatic arterial injection of clofazimine in lipiodol injection. [Subjects will be assessed for side effects related to the study treatment ( vital signs, full blood count, biochemistry etc) on day 2, 3, 4, 7, 14, 21 and 28 days. On day 28 patients will undergo a CT scan/angiogram to assess the extent of the primary malignant disease and presence of metastatic disease following the study treatment based on the Response Evaluation Criteria in Solid Tumours (RECIST) criteria.]