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

NCT01127074 | Completed Phase 1

• 1 other identifier: 01 KV 9540
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Metastatic Breast Cancer

Keywords

metastatic breast cancer; breast cancer stage IV; vaccination; CD80; immunotherapy

Outcome Measures

Primary Outcomes (2)

• safety of KS24.22 administration

  2 years

• feasibility

Secondary Outcomes (3)

• immunological response

  2 years

• progression free survival

• overall survival

Study Arms (1)

KS24.22-vaccination

EXPERIMENTAL

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

Interventions

KS24.22 cells BIOLOGICAL

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.

KS24.22-vaccination

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• organ transplanted patients

Sponsors & Collaborators

• University Hospital Tuebingen: lead
• Paul Ehrlich Institute, Langen, Germany: collaborator

Study Sites (1)

Univ. of Tuebingen, Dep. Obst. and Gynecology

Tübingen, 72076, Germany

Location

Related Publications (1)

• Guckel B, Stumm S, Rentzsch C, Marme 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):129-40. doi: 10.1007/s00262-004-0583-z. Epub 2004 Sep 9.

  PMID: 15365776 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Diethelm Wallwiener

  University Hospital Tuebingen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 18, 2010
• First Posted: May 20, 2010
• Study Start: March 1, 2002
• Primary Completion: July 1, 2008
• Study Completion: January 1, 2010
• Last Updated: May 20, 2010

Record last verified: 2010-05

Locations

DE (1)