Randomized Trial With Dendritic Cells in Patients With Metastatic Colorectal Cancer
Status:
Completed
Trial end date:
2014-09-01
Target enrollment:
Participant gender:
Summary
The different alternatives used since 1996 to treat metastatic colorectal cancer (MCRC) have
increased the mean survival of these patients. This outstanding advance is due to the
extended indications for resection of hepatic metastases and to the use of new
chemotherapeutic drugs (fluoropyrimidine, irinotecan and oxaliplatin) and monoclonal
antibodies (bevacizumab, cetuximab and panitumumab). However, none of these treatments is
curative and the majority of patients are overwhelmed by the illness. The first line of
treatment for MCRC is FOLFOX and the second, irinotecan plus cetuximab for patients with wild
type KRAS gene (60%) with a 30% responses, and bevacizumab plus irinotecan with a 5-10% of
responses, in patients with mutated KRAS (40%). A treatment with autologous dendritic cells
(DCs) pulsed with autologous tumour antigens is proposed as a third line of therapy. A
randomized phase II trial would be performed, by selecting two groups of patients, one of
them would be treated with the best supportive treatment and the other with DCs plus the best
supportive treatment. The aim of the study would be to analyze the outcome after 4 months of
treatment. In patients treated with DCs, IFN-γ spot forming cells and proliferative responses
would be determined pre and post treatment in lymphocytes stimulated with autologous DCs
pulsed with autologous tumour antigens. Pre and post treatment serum levels of IFN-γ, TNF-α,
TGF-β e IL-12, would also be measured.