A Phase 1 interventional study of KS24.22 cells in Metastatic Breast Cancer, sponsored by University Hospital Tuebingen. Completed at 1 site in Germany. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2010-05-20.
Sponsored by University Hospital Tuebingen · Phase 1, Interventional, and Treatment
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, KS24.22, genetically modified to express CD80 and Her-2/neu, and to evaluate the efficacy of inducing tumor antigen-specific immune responses in human leukocyte antigen(HLA)-A*02-matched patients with metastatic breast cancer.
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, KS24.22 cells were thawed and lethally irradiated. KS24.22 cells were adjusted to 10E7/ml in Ringer-Lactate-solution, transferred to 1 ml syringes and stored on ice until injected within a time frame of 2h. Vaccinations were given i.d. in the thigh with a total volume of 1 ml divided between two injection sites.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 15 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
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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, KS24.22 cells were thawed and lethally irradiated. KS24.22 cells were adjusted to 10E7/ml in Ringer-Lactate-solution, transferred to 1 ml syringes and stored on ice until injected within a time frame of 2h. Vaccinations were given i.d. in the thigh with a total volume of 1 ml divided between two injection sites.
Biological: KS24.22 cells
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, KS24.22 cells were thawed and lethally irradiated (200 gray). KS24.22 cells were adjusted to 107/ml in Ringer-Lactate-solution, transferred to 1 ml syringes and stored on ice until injected within a time frame of 2h. Vaccinations were given i.d. in the thigh with a total volume of 1 ml divided between two injection sites.
safety of KS24.22 administration
Time frame: 2 years
feasibility
immunological response
Time frame: 2 years
progression free survival
overall survival
This study is completed, as verified in May 2010. You cannot join it, but the record below documents what was studied.
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University Hospital Tuebingen