Clinical trial NCT00081900 (phase 1/phase 2, status: terminated)
Conditions: carcinoma, hepatocellular
ICD codes: C22.0, C4A.9, C7B.1, C4A.0, C4A.31, C4A.51, C4A.8
Drugs: denspm )
SMILES: CCNCCCNCCCNCCCNCC
Reason stopped: 
    this study was terminated early by genzyme because there were insufficient data to support
    clinical benefit to hcc patients on the study.
  
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically proven HCC, or if the patient is not a medically appropriate candidate
             for biopsy, then all of the following criteria must be met: A.History of cirrhosis or
             chronic hepatitis B virus (HBV) or hepatitis C virus (HCV)infection. B.A focal liver
             lesion ≥ 3 cm on CT or MRI with arterial hypervascularization. C.Confirmation of the
             liver lesion by a second imaging modality (US/ CT/ MRI).D.AFP ≥1000 ng/ml, or ≥ 4000
             ng/ml if Hepatitis B surface Ag positive.

          -  For recurrent HCC, radiographic evidence of progression.

          -  Not appropriate for curative therapy (surgical resection) or refuses potentially
             curative therapy

          -  Measurable disease, defined as having at least one measurable intrahepatic tumor
             lesion (using Response Criteria in Solid Tumors [RECIST]). Prior therapy is acceptable
             only if there is documented progression of the selected measurable lesion(s) following
             completion of the therapy.

          -  Required laboratory values

          -  Renal function: serum creatinine ≤1.2mg/dL Hematologic function: leukocyte count
             ≥1,500/mm3, platelet count ≥50,000/mm3 Hepatic function: transaminases ≤5x upper limit
             normal (ULN), albumin ≥2.0g/dL, total bilirubin ≤3.5mg/dL Sodium: ≥130mEq/L

          -  Karnofsky Performance Status of ≥ 60%

          -  CLIP Score ≤ 3

          -  If female and of childbearing potential, must use an effective method of contraception

          -  Willing and able to provide written informed consent

        Exclusion Criteria:

          -  Has received localized therapy (e.g., radiotherapy, RFA, injection therapy, or
             chemoembolization)within 6 weeks prior to treatment, Day1. Prior local lesion-specific
             radiotherapy is acceptable only if the treated lesion(s) is/are not the only source of
             measurable disease or there is documented progression of the treated lesion(s)
             following completion of the therapy.

          -  Has received any other systemic therapy for HCC within 3 weeks prior to treatment, Day
             1. Prior therapy is acceptable only if there is documented progression following
             completion of the therapy.

          -  Has received another investigational therapy within 30 days prior to study entry

          -  Has any unstable serious or life-threatening medical condition, other than HCC (e.g.,
             unstable angina, other cancer diagnosis with the exception of basal cell carcinoma, or
             patients with prior malignancy except for adequately treated basal cell carcinoma(s),
             in situ cervical cancer, or other cancer for which the patient has been disease-free
             for five or more years)

          -  Newly noted clinically significant electrocardiogram (ECG) abnormality

          -  Clinically significant abnormal laboratory result that is not consistent with
             patient's clinical course

          -  Active gastrointestinal bleeding resulting in clinically significant hemodynamic
             changes or a reduction in hemoglobin.

          -  Active inflammatory bowel disease (IBD) and/or active gastric or duodenal ulcer
             disease

          -  Has a history of central nervous system (CNS) metastases, seizure disorder or
             neurological exam finding suggestive of CNS metastases

          -  Has Stage B or C liver cirrhosis according to Child-Pugh-Turcotte Classification

          -  Has ascites refractory to diuretic therapy

          -  Has any contraindication for MRI procedure

          -  If female of childbearing potential, has a positive serum HCG

          -  If female, is lactating