Intervention: ARSENIC TRIOXIDE
Trial phase: Phase 2
ATC code: L01XX27
SMILES: O=[As]O[As]=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: arsenic trioxide: 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.
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