Ignite Creation Date:
2024-05-05 @ 9:45 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006198
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2000-09-09
Brief Title:
Chronic Thalidomide Administration in Patients Undergoing Chemoembolization for Unresectable Hepatocellular Cancer
Sponsor:
National Center for Research Resources NCRR
Organization:
National Center for Research Resources NCRR
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2004-01
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
This is a clinical trial to test the safety and efficacy of the drug thalidomide in combination with a procedure called chemoembolization in patients with inoperable liver cancer Chemoembolization is the process by which chemotherapy is instilled directly into the blood vessels feeding the tumor so that the blood vessels feeding the tumor may be blocked Chemoembolization consists of two separate procedures It will be done by infusing chemotherapy with the drug doxorubicin through the hepatic artery into the liver and then by infusing collagen to cut off the blood supply to the tumor A catheter will be inserted at various times to allow for these infusions
The objectives are to investigate the feasibility and potential activity of chronic administration of thalidomide in patients with unresectable hepatocellular cancer who receive chemoembolization to predominant tumor masses The toxicity of thalidomide in these patients will be evaluated Overall safety will also be assessed Serum levels of angiogenic cytokines such as VEGF bFGF and TNF-a that are believed to have a role in hepatocellular carcinoma will be collected
The objectives are to investigate the feasibility and potential activity of chronic administration of thalidomide in patients with unresectable hepatocellular cancer who receive chemoembolization to predominant tumor masses The toxicity of thalidomide in these patients will be evaluated Overall safety will also be assessed Serum levels of angiogenic cytokines such as VEGF bFGF and TNF-a that are believed to have a role in hepatocellular carcinoma will be collected
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 |
|---|---|---|---|
| M01RR000096 | NIH | None | httpsreporternihgovquickSearchM01RR000096 |