Treatment of Hepatocellular Carcinoma With Tetrathiomolybdate
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
Hepatocellular carcinoma (HCC) is a deadly tumor for which the incidence is increasing in the
United States, primarily due to prevalence of hepatitis C infection. An important aspect of
the development of HCC is that it occurs in patients who have underlying cirrhosis of the
liver, thereby limiting the therapeutic options. There is potential curative treatment for
these patients, such as resection of the tumor lesion and liver transplantation, but these
treatments are feasible in a small percent of patients only. Furthermore, the majority of the
patients with HCC are also not candidates for palliative treatments such as percutaneous
ablation of the tumor, chemotherapy or radiation. Additionally, it has been shown that these
palliative treatment modalities do not alter survival, and are associated with significant
risks. Therefore, there are no treatment options for most patients with HCC. A new theory has
emerged in the fight against cancer through inhibition of angiogenesis (development of new
blood vessels). The hypothesis being that if there is no blood supply "feeding" the tumor
cells cannot divide or survive. One such approach, pioneered in this institution by Drs.
George Brewer and Sofia Merajver, is the anticopper approach using the medication
tetrathiomolybdate (TM). By creating a mild copper deficiency state, several pathways
required for angiogenesis are inhibited. They performed a Phase I trial in which patients
with metastatic cancer were treated with TM resulting in decrease tumor vascularity. TM had
excellent safety profile in this patient population. HCC is well known to be a hypervascular
tumor. An antiangiogenesis approach might provide a novel treatment for this HCC. This is a
pilot study of 10 patients with HCC who are not candidates for curative surgical therapy with
resection or liver transplantation, nor for ablative techniques. Patients seen in the General
Liver clinic and Liver Transplant clinic who have an overall good performance status, with an
expected survival of more than 6 months will be enrolled. After an initial evaluation, they
will be given 120 mg/day of TM in divided doses for one year. The size and vascularity of the
tumor will be evaluated by magnetic resonance imaging (MRI). The primary outcome of this
study is to prevent tumor progression.