Status:
TERMINATED
Dendritic Cell Based Therapy of Metastatic Breast Cancer
Lead Sponsor:
Herlev Hospital
Conditions:
Metastatic Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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...
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 autolo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00197925
Start Date
September 1 2004
Last Update
January 3 2008
Active Locations (1)
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1
Department of Oncology
Herlev, Denmark, 2970