A Phase II Protocol of Arsenic Trioxide (Trisenox) in Subjects With Advanced Primary Carcinoma of the Liver
Condition: Carcinoma, Hepatocellular
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Intervention: arsenic trioxide
Intervention description: Trisenox will be diluted with 100 to 250 mL 0.9% Sodium Chloride injection, USP, using proper aseptic technique, immediately after withdrawal from the ampule. The Trisenox ampule is single-use and does not contain any preservatives. Unused portions of each ampule should be discarded properly. Trisenox is not to be mixed with other medications.
The loading dose of Trisenox will be administered intravenously over 2 hours. The infusion duration may be extended up to 4 hours if acute vasomotor reactions are observed. The drug will be administered IV through a functional peripheral or central venous line. Trisenox is not a vesicant, and may be a mild irritant if administered into the skin without dilution.
Intervention MeSH terms: Arsenic Trioxide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: livers, hepatocellular carcinoma (HCC)

Summary:

      The purpose of this study is: evaluate the safety and activity of administering arsenic
      trioxide (Trisenox) in the treatment of unresectable or metastatic primary liver cancer, to
      evaluate the qualitative and quantitative toxicities of this treatment, and to measure the
      response to treatment and the patterns of failure and survival. The primary response
      measurements will be the achievement of an objective tumor response, response duration and
      progression-free survival
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed Informed Consent

          -  ECOG/Zubrod/SWOG Performance Status < 2

          -  Life expectancy > 12 weeks

          -  Male or female' age >18 years Subjects of childbearing potential must be using an
             effective means of contraception.

          -  Histologic diagnosis of HCC or cholangiocarcinoma that is locally advanced but cannot
             be treated adequately by radiotherapy or surgery (more than one lesion, portal vein
             involvement, or poor hepatic reserve); or metastatic disease or an AFB > 20 w/CT scan
             consistent with HCC

          -  Renal function: Serum creatinine < 2.0 mg/dl

          -  Serum calcium < 12 mg/dl

          -  Serum electrolytes, including magnesium and potassium, within normal limits

        Exclusion Criteria:

          -  Pregnant or lactating females

          -  Myocardial infarction or ischemia within the 6 months before Cycle 0' Day 0

          -  Uncontrolled' clinically significant dysrhythmia

          -  Known left ventricular Ejection Fraction below the normal limit for UTMB

          -  History of prior malignancy within the prior five years, with the exception of
             non-melanoma carcinomas of the skin, and carcinoma in situ of the cervix

          -  More than one prior chemotherapy regimens for liver cancer (subjects who are receiving
             antineoplastic agents for non-malignant conditions, such as methotrexate for
             rheumatoid arthritis, must be off such therapy for at least four weeks prior to
             receiving the first dose of protocol therapy, and may not receive such therapy while
             participating in this protocol)

          -  Receiving any other chemotherapy or cytokine therapy

          -  Subjects receiving radiation therapy (Trisenox will be held during the administration
             of palliative or emergent radiotherapy)

          -  Subjects who have received radiofrequency ablation or hepatic arterial embolization
             within the past four weeks (patients who have received prior RFA or HAE are otherwise
             eligible)

          -  Prior radiotherapy to an indicator lesion unless there is objective evidence of tumor
             growth in that lesion

          -  Uncontrolled metastatic disease of the central nervous system

          -  Prior and on-going Grade 2-4 peripheral neuropathy, as measured by NCI Common Toxicity
             Criteria version 3.0

          -  Radiotherapy within the 2 weeks before Cycle 1' Day 1

          -  Surgery within the 2 weeks before Cycle 1' Day 1

          -  Any co morbid condition that' in the view of the attending physician' renders the
             subject at high risk from treatment complications