Dendritic Cell Based Therapy of Metastatic Breast Cancer - Full Text View

Sponsored by:	Herlev Hospital
Information provided by:	Herlev Hospital
ClinicalTrials.gov Identifier:	NCT00197925

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 I Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Vaccination With Autologous Dendritic Cells Pulsed With Onco-Peptides for Treatment of Patients With Metastatic Breast Cancer.A Phase I/II Study

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:

Svane IM, Pedersen AE, Johnsen HE, Nielsen D, Kamby C, Gaarsdal E, Nikolajsen K, Buus S, Claesson MH. Vaccination with p53-peptide-pulsed dendritic cells, of patients with advanced breast cancer: report from a phase I study. Cancer Immunol Immunother. 2004 Jul;53(7):633-41. Epub 2004 Feb 25.

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

Keywords provided by Herlev Hospital:

breast cancer
dendritic cells
vaccine

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009