Vaccination With Autologous Dendritic Cells Pulsed With Allogeneic Tumour Lysate (MelCancerVac) for the Treatment of Patients With Advanced or Metastatic Non-Small Cell Lung Cancer. A Phase II Study
Vaccination with autologous dendritic cells pulsed with allogeneic melanoma cell lysate
(MelCancerVac) in combination with the Cox-2 inhibitor of celecoxib for the treatment of
patients with advanced or metastatic non-small cell lung cancer (NSCLC). Adjuvant Aldara
cream will be used as adjuvant for induction of inflammation at the injection site, and the
lymphocyte growth factor of interleukin-2 (IL-2) will be given as s.c. injection. The
treatment aims at boosting the patient's specific immune system against the cancer cells.
Patients with disseminated, inoperable NSCLC after chemotherapy and patients not wanting
chemotherapy for which no other systemic treatments can be offered.
Primary objective: to measure the antigen specific immunological reaction between vaccine
antigens and the patients' immune system in vivo and in vitro.
Secondary objectives: to estimate the patients' survival time, to estimate response
according to RECIST criteria, and to estimate the patients' quality of life during the study
The study is designed as an open, phase II, clinical study and will be carried out in
accordance with the present protocol, ICH/GCP Guidelines and national, regulatory
The first patient is expected to be included towards the end of 2006. Inclusion period will
continue for 2 years. Follow-up will continue for approx. 6 months prior to reporting.
Fifty patients are planned for inclusion. In case none of the first fourteen (14) evaluable
patients will respond, the inclusion and the study will be discontinued.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary objective: to measure the antigen specific immunological reaction between vaccine antigens and the patients' immune system in vivo and in vitro.
anders mellemgaard, MD PhD
Dept of Oncology, herlev university hospital
Denmark: Danish Medicines Agency
Dendric cells in lungcancer