Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00228189
Status:
COMPLETED
Last Update Posted:
2010-11-30
First Post:
2005-09-27
Brief Title:
Carcinoembryonic Antigen-loaded Dendritic Cells in Advanced Colorectal Cancer Patients
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
Official Title:
Induction of Specific T Cell Responses in Colorectal Cancer Patients With Liver Metastases Upon Vaccination With Autologous Dendritic Cells Pulsed With CEA-peptide or Electroporated With CEA-RNA Evaluation of in Vivo Immune Response
Status:
COMPLETED
Status Verified Date:
2010-11
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:
Dendritic cells DCs are the professional antigen-presenting cells of the immune system As such they are currently used in clinical vaccination protocols in cancer patients We evaluate the ability of mature DCs pulsed with carcinoembryonic antigen CEA-peptide arm A or electroporated with CEA-mRNA arm B to induce CEA-specific T cell responses in patients with resectable liver metastases from colorectal cancer To evaluate immune responses CEA-specific T cell reactivity is monitored in peripheral blood resected abdominal lymph nodes tumor tissue and biopsies of vaccination sites and post-treatment DTH skin tests Patients are vaccinated intradermally and intravenously with CEA-peptide pulsed mature DCs three times prior to resection of liver metastases In 2007 a side-study has been added arm C in which patients with stage III or high-risk stage II colorectal cancer that are amenable for standard adjuvant oxaliplatincapecitabine therapy are vaccinated with CEApeptide-pulsed DCs Also in this group safety and immune responses in peripheral blood and the DTH-skin test are the primary endpoints Results are compared with the results obtained in arm A
Detailed Description:
None
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 |
|---|---|---|---|
| NWO920-03-250 | None | None | None |