Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006006
Status:
COMPLETED
Last Update Posted:
2013-02-11
First Post:
2000-07-05
Brief Title:
Thalidomide Plus Interferon Alfa in Treating Patients With Progressive Liver Cancer That Cannot be Surgically Removed
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Thalidomide for Unresectable Hepatocellular Cancer With Optional Interferon Alpha-2a Upon Disease Progression
Status:
COMPLETED
Status Verified Date:
2003-09
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:
Phase II trial to study the effectiveness of thalidomide plus interferon alfa in treating patients who have progressive liver cancer that cannot be surgically removed Thalidomide may stop the growth of liver cancer by stopping blood flow to the tumor Interferon alfa may interfere with the growth of the cancer cells Combining thalidomide and interferon alfa may kill more tumor cells
Detailed Description:
OBJECTIVES
I Determine the feasibility and activity of thalidomide in patients with unresectable hepatocellular carcinoma
II Evaluate the toxicity of thalidomide in these patients III Assess the use of interferon alfa in patients who develop disease progression while being treated with thalidomide
OUTLINE This is a multicenter study
Patients receive oral thalidomide once daily Patients on a stable dose of thalidomide for at least 4 weeks with evidence of progressive disease receive interferon alfa subcutaneously twice daily Treatment continues in the absence of disease progression after initiation of interferon alfa therapy or unacceptable toxicity
I Determine the feasibility and activity of thalidomide in patients with unresectable hepatocellular carcinoma
II Evaluate the toxicity of thalidomide in these patients III Assess the use of interferon alfa in patients who develop disease progression while being treated with thalidomide
OUTLINE This is a multicenter study
Patients receive oral thalidomide once daily Patients on a stable dose of thalidomide for at least 4 weeks with evidence of progressive disease receive interferon alfa subcutaneously twice daily Treatment continues in the absence of disease progression after initiation of interferon alfa therapy or unacceptable toxicity
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 |
|---|---|---|---|
| CDR0000068014 | REGISTRY | PDQ Physician Data Query | None |
| NYU-9938 | None | None | None |
| NCI-101 | None | None | None |