Vaccination of Metastatic Breast Cancer Patients With a CD80-modified Allogeneic Cancer Cell Line (KS2422)

Metastatic Breast Cancer Clinical Trial

— KS2422-vacc  

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 (KS24.22)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01127074
• Other study ID #: 01 KV 9540
• Status: Completed
• Phase: Phase 1
• First received: May 18, 2010
• Last updated: May 19, 2010
• Start date: March 2002
• Est. completion date: January 2010

Study information

• Verified date: May 2010
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institute, Langen, Germany
• Study type: Interventional

Clinical Trial 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, 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.

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, 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 2010
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

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.

Locations

Country	Name	City	State
Germany	Univ. of Tuebingen, Dep. Obst. and Gynecology	Tuebingen

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Tuebingen	Paul Ehrlich Institute, Langen, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Gückel B, Stumm S, Rentzsch C, Marmé A, Mannhardt G, Wallwiener D. A CD80-transfected human breast cancer cell variant induces HER-2/neu-specific T cells in HLA-A*02-matched situations in vitro as well as in vivo. Cancer Immunol Immunother. 2005 Feb;54(2) — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety of KS24.22 administration		2 years	Yes
Primary	feasibility			Yes
Secondary	immunological response		2 years	No
Secondary	progression free survival			No
Secondary	overall survival			No