Ignite Creation Date:
2024-05-05 @ 10:30 PM
Last Modification Date:
2024-10-26 @ 10:20 AM
Study NCT ID:
NCT01127074
Status:
COMPLETED
Last Update Posted:
2010-05-20
First Post:
2010-05-18
Brief Title:
Vaccination of Metastatic Breast Cancer Patients With a CD80-modified Allogeneic Cancer Cell Line KS2422
Sponsor:
University Hospital Tuebingen
Organization:
University Hospital Tuebingen
Study Overview
Official Title:
Phase 1 Study Induction of Systemic Immune Responses in Metastatic Breast Cancer Patients by Vaccination With a CD80-modified Devitalized HLA-A0201 Breast Cancer Cell Line KS2422
Status:
COMPLETED
Status Verified Date:
2010-05
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:
KS2422-vacc
Brief Summary:
In the last few years there has been a great attempt to develop active immunotherapies for breast cancer patients BCPs using undefined as well as selected antigens to activate tumor specific T-lymphocytes The purpose of this phase-I study was to determine the safety and feasibility of vaccinations with an allogeneic breast cancer cell line KS2422 genetically modified to express CD80 and Her-2neu and to evaluate the efficacy of inducing tumor antigen-specific immune responses in human leukocyte antigenHLA-A02-matched patients with metastatic breast cancer
Detailed Description:
The trial was designed as an open label phase-I Informed consent was given twice by the patients 1st for HLA-typing 2nd for participation in the vaccination trial
The first four vaccinations which were given every two weeks were followed by four monthly vaccinations Additional vaccinations were permitted on request for patients who exhibited stable disease SD
Immediately before administration KS2422 cells were thawed and lethally irradiated KS2422 cells were adjusted to 10E7ml in Ringer-Lactate-solution transferred to 1 ml syringes and stored on ice until injected within a time frame of 2h Vaccinations were given id in the thigh with a total volume of 1 ml divided between two injection sites
The first four vaccinations which were given every two weeks were followed by four monthly vaccinations Additional vaccinations were permitted on request for patients who exhibited stable disease SD
Immediately before administration KS2422 cells were thawed and lethally irradiated KS2422 cells were adjusted to 10E7ml in Ringer-Lactate-solution transferred to 1 ml syringes and stored on ice until injected within a time frame of 2h Vaccinations were given id in the thigh with a total volume of 1 ml divided between two injection sites
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