Clinical trial · Interventional
Dendritic Cell Based Therapy of Metastatic Breast Cancer
Vaccination With Autologous Dendritic Cells Pulsed With Onco-Peptides for Treatment of Patients With Metastatic Breast Cancer.A Phase I/II Study
NCT00197925CI-TRIAL-00001082terminatedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): all patients recruited
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Onco-peptide loaded autologous dendritic cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Primary aim of the study is to evaluate tolerability and safety of the treatment.
Secondary outcomes (1)
- measure
- Secondary aims: evaluation of treatment induced immune response and clinical response.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- BACKGROUNDSvane 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. doi: 10.1007/s00262-003-0493-5. Epub 2004 Feb 25. PMID 14985857