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A Study to Assess PV-10 Chemoablation of Cancer of the Liver - NCT00986661-92123(Clinical Trial 353164)



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City:  San Diego
State:  
CA
Zip Code: 92123
Conditions: Cancer Metastatic to the Liver - Recurrent Hepatocellular Carcinoma
Purpose: This open-label study will evaluate the safety, tolerability, pharmacokinetics and effect on tumor growth following a single intralesional injection of PV-10 in subjects with either recurrent hepatocellular carcinoma (HCC) or cancer metastatic to the liver. In each of two planned dose cohorts there will be three subjects. Dose escalation will occur following assessment of safety and tolerability in the first cohort.
Study summary:
Criteria: Inclusion Criteria: - Age 18 years or older, males and females. - Histologically or cytologically confirmed cancer metastatic to the liver or recurrent HCC. - The Target Lesion must be determined to be amenable to percutaneous injection by the treating physician. - The Target Lesion must have measurable disease, defined as a unidimensionally measurable lesion ≥ 1.0 cm in longest diameter by helical CT. - The Target Lesion must be ≤ 3.8 cm in longest diameter (e.g., ≤ 30 cm3 in volume). - Performance status of Karnofsky scale 60%-100% or ECOG performance scale 0-2. - Life expectancy ≥ 12 weeks. - Hematopoietic Function: WBC ≥ 2,500/mm3; ANC ≥ 1000/mm3; Hemoglobin ≥ 8 g/dL; Platelet count ≥ 50,000/mm3; Coagulation: INR ≤ 1.3. - AST and ALT < 5 times ULN; ALP < 5 times ULN; Bilirubin ≤ 1.5 times ULN; Creatinine ≤ 1.5 times ULN and eGFR ≥ 50. - Thyroid Function: Total T3 or free T3, total T4 or free T4 and THS within normal limits (WNL). - Renal Function: Adequate renal function in the opinion of the Investigator with no clinically significant renal impairment or uncontrolled renal disease. - Cardiovascular Function: Adequate cardiovascular function in the opinion of the Investigator with no clinically significant uncontrolled cardiovascular disease. - Respiratory Function: Adequate respiratory function in the opinion of the Investigator with no clinically significant uncontrolled respiratory disease. - Immunological Function: Adequate immune system function in the opinion of the Investigator with no known immunodeficiency disease. - Informed Consent: Signed by the subject prior to screening. Exclusion Criteria: - Primary Resectable HCC - Surgery: Subjects who have received hepatic surgery, ablation or chemoembolization within 4 weeks of PV-10 administration. - Radiation Therapy: Hepatic radiation within 4 weeks of PV-10 administration. - Chemotherapy: Chemotherapy within 4 weeks of PV-10 administration (6 weeks for nitrosoureas or mitomycin C). - Investigational Agents: Investigational agents within 4 weeks (or 5 half-lives) of PV-10 administration. - Phototoxic or Photosensitizing Agents: Concomitant agents posing a clinically significant risk of photosensitivity reaction within 5 half-lives of PV-10 administration. - Concurrent or Intercurrent Illness: Uncontrolled diabetes; Significant concurrent or intercurrent illness, psychiatric disorders or alcohol or chemical dependence that would compromise Subject safety or compliance or interfere with interpretation of the study; Thyroid disease (subclinical or ongoing), goiter, partial thyroidectomy, previous radioiodine or surgically treated Graves' hyperthyroidism or cystic fibrosis, or taking thyroid hormone medication; Presence of clinically significant acute or unstable cardiovascular, cerebrovascular (stroke), renal, gastrointestinal, pulmonary, immunological (with the exception of the presence of hepatitis B virus (HBV), viral hepatitis, or cirrhosis), endocrine, or central nervous system disorders; Current encephalopathy or current treatment for encephalopathy; A documented variceal hemorrhage within 4 months of screening; History of human immunodeficiency virus or acquired immune deficiency syndrome; The clinical presence of ascites. - Pregnancy: Female subjects who are pregnant, lactating or have positive serum β HCG pregnancy test taken within 7 days of PV-10 administration; Fertile subjects who are not using effective contraception.
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Data Source: ClinicalTrials.gov
Date Processed: January 6, 2011
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