Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006016
Status:
COMPLETED
Last Update Posted:
2015-04-15
First Post:
2000-07-05
Brief Title:
Thalidomide and Chemoembolization With Doxorubicin in Treating Patients With Liver Cancer That Cannot be Removed by Surgery
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
An Evaluation of Chronic Thalidomide Administration in Patients Undergoing Chemoembolization for Unresectable Hepatocellular Cancer
Status:
COMPLETED
Status Verified Date:
2013-01
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:
This phase II trial is studying the effectiveness of combining thalidomide and chemoembolization in treating patients who have liver cancer that cannot be removed by surgery Thalidomide may stop the growth of liver cancer by stopping blood flow to the tumor Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping chemotherapy drugs near the tumor Combining thalidomide with chemoembolization may kill more tumor cells
Detailed Description:
OBJECTIVES
I Determine the feasibility and potential activity of thalidomide in patients with unresectable hepatocellular carcinoma who are undergoing chemoembolization to predominant tumor masses
II Determine the toxicity of this regimen of these patients III Determine the overall survival of patients treated with this regimen IV Determine the serum levels of vascular endothelial growth factor basic fibroblast growth factor and tumor necrosis factor alpha in patients treated with this regimen
OUTLINE
Patients receive oral thalidomide daily beginning 4 weeks before the first planned chemoembolization procedure Thalidomide administration is stopped 24 hours before each chemoembolization procedure and then restarted at 24 hours after completion of each procedure OR when blood counts and levels of bilirubin and transaminases recover whichever occurs later Thalidomide treatment continues in the absence of disease progression or unacceptable toxicity
Patients undergo placement of a visceral arterial catheter Patients receive doxorubicin as a chemoemulsion via the arterial catheter into 1 hepatic lobe only under angiographic guidance Immediately after delivery of the chemoemulsion patients undergo particulate embolization The opposite lobe if involved is treated within 3-5 weeks of treatment of the initial lobe Patients are reevaluated for repeat chemoembolization within 8-12 weeks of the last chemoembolization For eligible patients each lobe is treated separately a second time in the same sequence in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 75 patients will be accrued for this study within 18 months
I Determine the feasibility and potential activity of thalidomide in patients with unresectable hepatocellular carcinoma who are undergoing chemoembolization to predominant tumor masses
II Determine the toxicity of this regimen of these patients III Determine the overall survival of patients treated with this regimen IV Determine the serum levels of vascular endothelial growth factor basic fibroblast growth factor and tumor necrosis factor alpha in patients treated with this regimen
OUTLINE
Patients receive oral thalidomide daily beginning 4 weeks before the first planned chemoembolization procedure Thalidomide administration is stopped 24 hours before each chemoembolization procedure and then restarted at 24 hours after completion of each procedure OR when blood counts and levels of bilirubin and transaminases recover whichever occurs later Thalidomide treatment continues in the absence of disease progression or unacceptable toxicity
Patients undergo placement of a visceral arterial catheter Patients receive doxorubicin as a chemoemulsion via the arterial catheter into 1 hepatic lobe only under angiographic guidance Immediately after delivery of the chemoemulsion patients undergo particulate embolization The opposite lobe if involved is treated within 3-5 weeks of treatment of the initial lobe Patients are reevaluated for repeat chemoembolization within 8-12 weeks of the last chemoembolization For eligible patients each lobe is treated separately a second time in the same sequence in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 75 patients will be accrued for this study within 18 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| N01CM17103 | NIH | CTEP | httpsreporternihgovquickSearchN01CM17103 |
| NCI-2012-02352 | REGISTRY | None | None |
| NCI-99 | None | None | None |
| CDR0000068025 | None | None | None |
| NYU-9937 | OTHER | None | None |
| 99 | OTHER | None | None |