Dendritic Cell Based Therapy of Metastatic Breast Cancer

Phase 1

Terminated

• Conditions: Metastatic Breast Cancer

• Registration Number: NCT00197925
• Lead Sponsor: Herlev Hospital

Brief Summary

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.

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.

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Status Verified: 2008-01
• Last Update Submitted: 2008-01-02
• Last Update Posted: 2008-01-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Primary aim of the study is to evaluate tolerability and safety of the treatment.

Secondary Outcome Measures

Name	Time	Method
Secondary aims: evaluation of treatment induced immune response and clinical response.

Trial Locations

Locations (1)

Department of Oncology; 🇩🇰 Herlev, Denmark