Status:
COMPLETED
Study of Pegylated Human Recombinant Arginase for Liver Cancer
Lead Sponsor:
Bio-Cancer Treatment International Limited
Collaborating Sponsors:
The University of Hong Kong
Chinese University of Hong Kong
Conditions:
Neoplasm
Hepatocellular Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine whether recombinant human arginase (PEG-BCT-100) is safe and effective in the treatment of advanced hepatocellular carcinoma (HCC).
Detailed Description
The primary objectives of this study are: * To establish a safe dose level for weekly intravenous administration of PEG- BCT-100 (rhArgIpeg5000) based on clinical and laboratory safety assessments fo...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of HCC according to the European Association for the Study of the Liver criteria
- Known underlying HCC etiology specified by hepatitis B, hepatitis C, post alcoholic cirrhosis, or other
- HCC lesion(s) which are not resectable and which are measurable by C-T scan
- Progression of or non-response of HCC lesions after treatments which are considered best standard of care - surgical resection, radiofrequency ablation, chemoembolization
- No cancer treatment or surgery within the prior 4 weeks, either chemotherapy, targeted biologic or enzymes, either approved or investigational;
- Males or females from 18 to 75 years-old, inclusive;
- Ability and willingness to provide written informed consent;
- Karnofsky performance status of 80% or above and expected survival of more than 12 weeks; and,
- Negative urine pregnancy test, if female, and willingness to use an effective method of contraception during the entire study period
Exclusion
- Advancing liver failure indicated by uncontrolled ascites, pleural effusions, encephalopathy, or a Child-Pugh score of C
- Significant hepatic, renal or bone marrow dysfunction indicated by total bilirubin \>40 µmol/L, evidence of bile duct obstruction, serum albumin \<30 g/L, serum SGOT \>5 x upper limit of normal, ANC \<1.0 x 10\^9/L, platelets \<100 x 10\^9/L, or INR \>2.0
- Significant cardiac or pulmonary disease defined by New York Heart Association (NYHA) Class III or IV, VEF \<50% by echo or MUGA, or a history of myocardial infarction within the past 6 months, significant unstable arrhythmia or evidence of ischemia on ECG
- Pregnant or nursing women. NOTE: Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Significant active infection including HIV requiring oral or parenteral anti-infective therapies;
- Use of investigational drug(s) within 4 weeks of enrollment; or,
- Prior treatment with arginine depleting agent.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00988195
Start Date
May 1 2008
End Date
August 1 2009
Last Update
March 14 2012
Active Locations (1)
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1
Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, The University of Hong Kong
Hong Kong, Hong Kong