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
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: 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 September 18, 2014