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NCT00006332 · ClinicalTrials.gov registry record · Phase 2
Treatment of Hepatocellular Carcinoma With Tetrathiomolybdate
A Phase 2 study, sponsored by National Center for Research Resources (NCRR).
- Completed
- Registry status
- Phase 2
- Development phase
NCT00006332: Completed Phase 2 study, sponsored by National Center for Research Resources (NCRR).
NCT00006332 is a Phase 2 study that has completed, run by National Center for Research Resources (NCRR). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00006332, a Phase 2 study, has completed, sponsored by National Center for Research Resources (NCRR).
- COMPLETED
- Registry status
- Phase 2
- Development phase
Study 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, wi
Interventions
- DRUG Tetrathiomolybdate
Trial Details
| Field | Value |
|---|---|
| Phase | Phase 2 |
What the finished NCT00006332 record still lists
NCT00006332 is an interventional study that assigns participants to a tested intervention. An enrollment target was not published in the registry record, which is common for early-stage or observational entries.
The record links to 0 conditions, and to 1 intervention - of which Tetrathiomolybdate is the first listed.
NCT00006332 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00006332 about?
NCT00006332 is a clinical study titled "Treatment of Hepatocellular Carcinoma With Tetrathiomolybdate". 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 ...
What is the current status of trial NCT00006332?
This trial is currently completed. It is a Phase 2 study.
What interventions are being tested in trial NCT00006332?
The interventions under investigation include: Tetrathiomolybdate (DRUG).
Who is sponsoring clinical trial NCT00006332?
This trial is sponsored by National Center for Research Resources (NCRR), which has 94 total clinical trials registered on ClinicalTrials.gov.