Dendritic Cell Based Therapy of Metastatic Breast Cancer

This study has been terminated.
(all patients recruited)
Sponsor:
Information provided by:
Herlev Hospital
ClinicalTrials.gov Identifier:
NCT00197925
First received: September 12, 2005
Last updated: January 2, 2008
Last verified: January 2008
  Purpose

The study aim to show if vaccination with autologous dendritic cells pulsed with onco-peptides in combination with adjuvant cytokine can induce a measurable immune response in patients with metastatic breast cancer, and to evaluate the clinical effect (objective response rate) of the vaccination regime.


Condition Intervention Phase
Metastatic Breast Cancer
Biological: Onco-peptide loaded autologous dendritic cells
Phase 1
Phase 2

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: Vaccination With Autologous Dendritic Cells Pulsed With Onco-Peptides for Treatment of Patients With Metastatic Breast Cancer.A Phase I/II Study

Resource links provided by NLM:


Further study details as provided by Herlev Hospital:

Primary Outcome Measures:
  • Primary aim of the study is to evaluate tolerability and safety of the treatment.

Secondary Outcome Measures:
  • Secondary aims: evaluation of treatment induced immune response and clinical response.

Estimated Enrollment: 40
Study Start Date: September 2004
Detailed Description:

HLA A2 positive patients are treated with PADRE and oncopeptide pulsed DC; p53, survivin and telomerase peptides. Each patient is given 6 immunizations with at least 5x106 peptide/lysate pulsed autologous DC. Vaccination 1-4 is given weekly and 4-6 at 2-week intervals. Those patients who exhibit stable disease, partial response or complete response after 6 injections will be given 4 more vaccinations at 2-week interval. The vaccine is applied by either intranodal or intradermal injection near the inguinal region. For adjuvant used IL-2 2 MIU sc. day 2-6. Scans and re-staging tests are performed at scheduled intervals throughout the study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically proven progressive metastatic or locally advanced breast cancer
  • No standard treatment indicated
  • Age: > 18
  • WHO-Performance Status 0-1
  • At least tone measurable tumor lesions according to the RECIST criteria.
  • Expression of the HLA-A2 tissue type
  • Life expectancy more than 3 months
  • Acceptable CBC and blood chemistry results
  • Written informed consent

Exclusion Criteria:

  • Patients with a history of any other neoplastic disease less than 5 years ago (excepting treated carcinomas in situ of the cervix and basal/squamous cell carcinomas of the skin).
  • Patients with metastatic disease in the central nervous system (CNS).
  • Patients with other significant illness including severe allergy, asthma, angina pectoris or congestive heart failure.
  • Patients with acute or chronic infection including HIV, hepatitis and tuberculosis.
  • Patients who are pregnant.
  • Patients who have received antineoplastic therapy including chemotherapy or immunotherapy less than 4 weeks before beginning the trial.
  • Patients who receive corticosteroids or other immunosuppressive agents.
  • Patients with active autoimmune diseases such as lupus erythematosus, rheumatoid arthritis or thyroiditis.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00197925

Locations
Denmark
Department of Oncology
Herlev, Denmark, 2970
Sponsors and Collaborators
Herlev Hospital
Investigators
Principal Investigator: Inge Marie Svane, MD, PHD Department of Oncology, Copenhagen University Hospital, Herlev, Herlev Ringvej 75, DK-2730 Herlev, Denmark
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00197925     History of Changes
Other Study ID Numbers: MA0415
Study First Received: September 12, 2005
Last Updated: January 2, 2008
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Herlev Hospital:
breast cancer
dendritic cells
vaccine

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

ClinicalTrials.gov processed this record on April 17, 2014