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View Clinical Trial (Medical Research Study)
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A Study to Assess PV-10 Chemoablation of Cancer of the Liver - NCT00986661-92123 (Clinical Trial 353164)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy353164.aspx
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| City: |
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San Diego |
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State:
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CA |
| Zip Code: |
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92123 |
| Conditions: |
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Cancer Metastatic to the Liver - Recurrent Hepatocellular Carcinoma |
| Purpose: |
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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.
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| Study summary: |
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| Criteria: |
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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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| Study is available at: |
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Sharp Memorial Hospital
San Diego, CA 92123
United States
Primary Contact:
Paul M. Goldfarb, M.D.
Email: gldfrb@aol.com
Phone: 858-637-7888
Secondary Contact:
Paul M Goldfarb, M.D.
Email: gldfrb@aol.com
Phone: 858 637 7888 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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