Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006332
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-10-04
Brief Title:
Treatment of Hepatocellular Carcinoma With Tetrathiomolybdate
Sponsor:
National Center for Research Resources NCRR
Organization:
National Center for Research Resources NCRR
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2003-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 mgday 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| M01RR000042 | NIH | None | httpsreporternihgovquickSearchM01RR000042 |