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

This study has been completed.
Sponsor:
Collaborator:
Paul Ehrlich Institute, Langen, Germany
Information provided by:
University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT01127074
First received: May 18, 2010
Last updated: May 19, 2010
Last verified: May 2010
  Purpose

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.


Condition Intervention Phase
Metastatic Breast Cancer
Biological: KS24.22 cells
Phase 1

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

Resource links provided by NLM:


Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:
  • safety of KS24.22 administration [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • feasibility [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • immunological response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • progression free survival [ Designated as safety issue: No ]
  • overall survival [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: March 2002
Study Completion Date: January 2010
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: KS24.22-vaccination

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.


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, 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01127074

Locations
Germany
Univ. of Tuebingen, Dep. Obst. and Gynecology
Tuebingen, Germany, 72076
Sponsors and Collaborators
University Hospital Tuebingen
Paul Ehrlich Institute, Langen, Germany
Investigators
Principal Investigator: Diethelm Wallwiener University Hospital Tuebingen
  More Information

Publications:
Responsible Party: Prof. D. Wallwiener, University of Tuebingen, Dep. of Obst. and Gynecology
ClinicalTrials.gov Identifier: NCT01127074     History of Changes
Other Study ID Numbers: 01 KV 9540
Study First Received: May 18, 2010
Last Updated: May 19, 2010
Health Authority: Germany: Paul-Ehrlich-Institute, Langen, Germany

Keywords provided by University Hospital Tuebingen:
metastatic breast cancer
breast cancer stage IV
vaccination
CD80
immunotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on November 20, 2014