Breast Cancer Clinical Trial
Official title:
Evaluation of Dendritic Cells Transfected With Survivin, hTERT and p53 mRNA as a Treatment for Patients With Metastatic Breast Cancer or Malignant Melanoma
The primary aim of this study is to evaluate the toxicity of the vaccine and the combination of the vaccine and Cyclophosphamide, and to evaluate the immune response induced by the vaccine. The secondary aim is to investigate the clinical tumour response and duration of tumour and immune response.
Phase I trial. Single center study; patients will be referred to the study center from other
institutions in Denmark. 14 patients will be included in this phase I trial DC vaccination
regime consists of primary 6 biweekly intradermal injections with transfected dendritic
cells, followed by monthly injections until progression; Cyclophosphamide is used as vaccine
adjuvant.
Defined procedures are employed for generation of autologous dendritic cells for clinical
application in a classified laboratory. Unmobilized leukapheresis will be used for isolation
of large-scale mononuclear cells, and dendritic cells will be generated from monocytes by
cytokine stimulation and transfected with mRNA encoding for hTERT, survivin and p53 if the
tumour express p53. Frozen preparations of dendritic cells will be prepared using automated
cryopreservation. Each patient will receive a minimum of 1x106 dendritic cells per treatment
supplemented with Cyclophosphamide 50 mg twice a day every second week. Toxicity including
autoimmunity will be evaluated using the Common Toxicity Criteria (CTC).
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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