Transfected Dendritic Cell Based Therapy for Patients With 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.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- to evaluate the toxicity of the vaccine in combination with Cyclophosphamide [ Time Frame: biweekly ] [ Designated as safety issue: Yes ]
- to investigate the clinical tumor response and the duration [ Time Frame: after 12 weeks ] [ Designated as safety issue: No ]
- to evaluate the duration of tumor and immunoresponse [ Time Frame: 3, 6, 9 months ] [ Designated as safety issue: No ]
- to evaluate immune response [ Time Frame: at 8 and 12 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||September 2009|
|Study Completion Date:||May 2014|
|Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
|Experimental: DC vaccination and Cyclophosphamide||
Biological: DC vaccine
DC vaccination, one vaccine biweekly
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00978913
|Department of Oncology, Herlev University Hospital|
|Herlev, Denmark, Dk 2730|
|Study Director:||Inge Marie Svane, prof.MD||Department of Oncology, Herlev University Hospital, Herlev Ringvej 75,2730 Herlev|