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 (KS24.22)
18 Years
80 Years
Female
Metastatic Breast Cancer
Trial Information
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 (KS24.22)
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.
Inclusion Criteria:
- proven diagnosis of carcinoma of the breast with distant metastatic disease
- patient received either anthracycline- or taxane-based chemotherapy ("state of the
art")
- Karnofsky Score (performance status) 80%
- HLA-*A0201-positive
- minimum life expectancy of 6 month
- written informed consent
- activation of patient's T-lymphocytes by mitogen antibodies and the cell line used
for vaccination
Exclusion Criteria:
- manifestation of CNS metastases
- immunosuppressive disease like AIDS, autoimmune disease
- no serious concomitant systemic medical disorders or active acute or systemic
infection
- pregnancy
- chemotherapies or radiotherapies in the 4 weeks preceding study entry
- biological response modifiers (antibodies, TNF, cytokines) or other immune therapies
in the 6 weeks preceding study entry (exclusion: hematopoetic growth factors)
- organ transplanted patients
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
safety of KS24.22 administration
Outcome Time Frame:
2 years
Safety Issue:
Yes
Principal Investigator
Diethelm Wallwiener
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Hospital Tuebingen
Authority:
Germany: Paul-Ehrlich-Institute, Langen, Germany
Study ID:
01 KV 9540
NCT ID:
NCT01127074
Start Date:
March 2002
Completion Date:
January 2010
Related Keywords:
- Metastatic Breast Cancer
- metastatic breast cancer
- breast cancer stage IV
- vaccination
- CD80
- immunotherapy
- Breast Neoplasms
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