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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00197925 |
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Date of registration:
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12/09/2005 |
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Primary sponsor: |
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Public title:
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Dendritic Cell Based Therapy of Metastatic Breast Cancer
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Scientific title:
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Vaccination With Autologous Dendritic Cells Pulsed With Onco-Peptides for Treatment of Patients With Metastatic Breast Cancer.A Phase I/II Study |
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Date of first enrolment:
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September 2004 |
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Target sample size:
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40 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00197925 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Inge Marie Svane, MD, PHD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Oncology, Copenhagen University Hospital, Herlev, Herlev Ringvej 75, DK-2730 Herlev, Denmark |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Metastatic Breast Cancer
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Intervention(s)
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Biological: Onco-peptide loaded autologous dendritic cells
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Primary Outcome(s)
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Primary aim of the study is to evaluate tolerability and safety of the treatment.
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Secondary Outcome(s)
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Secondary aims: evaluation of treatment induced immune response and clinical response.
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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