Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00197925
Status:
TERMINATED
Last Update Posted:
2008-01-03
First Post:
2005-09-12
Brief Title:
Dendritic Cell Based Therapy of Metastatic Breast Cancer
Sponsor:
Herlev Hospital
Organization:
Herlev Hospital
Study Overview
Official Title:
Vaccination With Autologous Dendritic Cells Pulsed With Onco-Peptides for Treatment of Patients With Metastatic Breast CancerA Phase III Study
Status:
TERMINATED
Status Verified Date:
2008-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
all patients recruited
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study aim to show if vaccination with autologous dendritic cells pulsed with onco-peptides in combination with adjuvant cytokine can induce a measurable immune response in patients with metastatic breast cancer and to evaluate the clinical effect objective response rate of the vaccination regime
Detailed Description:
HLA A2 positive patients are treated with PADRE and oncopeptide pulsed DC p53 survivin and telomerase peptides Each patient is given 6 immunizations with at least 5x106 peptidelysate pulsed autologous DC Vaccination 1-4 is given weekly and 4-6 at 2-week intervals Those patients who exhibit stable disease partial response or complete response after 6 injections will be given 4 more vaccinations at 2-week interval The vaccine is applied by either intranodal or intradermal injection near the inguinal region For adjuvant used IL-2 2 MIU sc day 2-6 Scans and re-staging tests are performed at scheduled intervals throughout the study
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