Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00154713
Status:
UNKNOWN
Last Update Posted:
2005-09-12
First Post:
2005-09-08
Brief Title:
Immunotherapy for Colorectal Cancers Using CEA-Pulsed Dendritic Cells and Subsequent IL-2 Treatment
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
A Phase III Clinical Study of Immunotherapy for Advanced Colorectal Cancers Using CEA-Pulsed Dendritic Cells Mixed With Tetanus Toxoid and Subsequent IL-2 Treatment
Status:
UNKNOWN
Status Verified Date:
2005-07
Last Known Status:
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:
The specific aims of this study are as follows
1 Primary endpoint to evaluate the clinical responses of vaccinated patients
2 Secondary endpoint to evaluate the safety of this treatment and the immune responses against CEA before and after the treatment
1 Primary endpoint to evaluate the clinical responses of vaccinated patients
2 Secondary endpoint to evaluate the safety of this treatment and the immune responses against CEA before and after the treatment
Detailed Description:
In this trial we will immunize metastatic colorectal cancer patients with recombinant CEA-pulsed DCs mixed with tetanus toxoid by subcutaneous injection Low dose IL-2 will be given subcutaneously following DC vaccination to boost the growth of T cells We will adapt Simons optimal two-stage design for this study In the first stage we will treat 12 patients to evaluate the safety of this new protocol If there are no severe toxicitiesside effects and there is at least one patient that had stable disease or better clinical response then we will proceed to the second stage and treat additional 25 patients We will follow the clinical outcome of these 37 patients The immune responses against CEA before and after vaccination will be examined
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