Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00250796
Status:
COMPLETED
Last Update Posted:
2010-01-07
First Post:
2005-11-04
Brief Title:
Trial of Thalidomide a- Interferon - Octreotide in Patients With Unresectable Hepatocellular Carcinoma
Sponsor:
University of New Mexico
Organization:
University of New Mexico
Study Overview
Official Title:
Trial of Thalidomide a- Interferon - Octreotide in Patients With Unresectable Hepatocellular Carcinoma
Status:
COMPLETED
Status Verified Date:
2009-12
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:
Primary Aim Determine the response rate and time to progression of the combination of thalidomide interferon and octreotide in patients with unresectable hepatocellular carcinoma cancer of the liver that cant be treated surgically
Secondary Aims
1 Determine the toxicity of this combination in this population
2 Determine the survival of this patient cohort treated with the combination
3 Determine the percent of patients with hepatocellular carcinoma who have a positive octreotide scan
Secondary Aims
1 Determine the toxicity of this combination in this population
2 Determine the survival of this patient cohort treated with the combination
3 Determine the percent of patients with hepatocellular carcinoma who have a positive octreotide scan
Detailed Description:
The purpose of this study is to determine the response rate and time to progression of the combination of thalidomide alfa interferon and octreotide Sandostatin LAR in patients with unresectable hepatocellular carcinoma If patients are eligible for and agree to take part in the study they will be assigned to one of two treatment arms depending on SSR status If SSR status is positive or unknown patients will receive oral doses of thalidomide starting at 200mg a day and increasing to 800mg at increments of 200 per week depending on tolerance They will also receive injections three times a week of alpha interferon and monthly injections of octreotide Sandostatin LAR 30 mg into their buttocks muscle
If the patient SSR status is negative patients will not be given subcutaneous injections of octreotide Sandostatin LAR but will receive the thalidomide and alfa interferon only
If the patient SSR status is negative patients will not be given subcutaneous injections of octreotide Sandostatin LAR but will receive the thalidomide and alfa interferon only
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