Spots Global Cancer Trial Database for Dendritic Cell Based Therapy of Metastatic Breast Cancer

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Trial Identification

Brief Title: Dendritic Cell Based Therapy of Metastatic Breast Cancer

Official Title: Vaccination With Autologous Dendritic Cells Pulsed With Onco-Peptides for Treatment of Patients With Metastatic Breast Cancer.A Phase I/II Study

Study ID: NCT00197925

Conditions

Metastatic Breast Cancer

Interventions

Onco-peptide loaded autologous dendritic cells

Study Description

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.