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Randomized Trial With Dendritic Cells in Patients With Metastatic Colorectal Cancer

This study has been completed.
Information provided by (Responsible Party):
Ramon Vilella Puig, Fundacion Clinic per a la Recerca Biomédica Identifier:
First received: August 9, 2011
Last updated: November 3, 2014
Last verified: November 2014
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.

Condition Intervention Phase
Colorectal Neoplasms
Drug: Dendritic Cell Vaccine
Other: Supportive treatment
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Phase II Trial in Patients With Progressive Stage IV Colorectal Cancer to Two Lines of Chemotherapy, in Order to Compare the Best Supportive Treatment Versus Treatment With Dendritic Cells Plus the Best Supportive Treatment

Resource links provided by NLM:

Further study details as provided by Fundacion Clinic per a la Recerca Biomédica:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: 4 months ]

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: 4 months ]

Enrollment: 52
Study Start Date: August 2011
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dendritic Cells Vaccine
Dendritic Cells Vaccine after 2 lines of chemotherapy
Drug: Dendritic Cell Vaccine
Vaccination with autologous dendritic cells loaded with autologous tumor antigens
Supportive treatment
Supportive treatment after 2 lines of chemotherapy
Other: Supportive treatment
Supportive treatment after progression of the illness after 2 lines of chemotherapy


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age over 18 years.
  • Capacity of understanding and signing the informed consent and to undergo the study procedures.
  • Previously treated with 2 lines of chemotherapy.
  • ECOG <= 2.
  • Adequate renal, hepatic and bone marrow function
  • Confirmed diagnosis of colorectal cancer with hepatic metastasis, suitable for biopsy.
  • Availability of tumor tissue, for maturing dendritic cells
  • RECIST.1 criteria

Exclusion Criteria:

  • Clinically relevant diseases or infections (HBV, HCV, HIV).
  • Pregnant or breast feeding women.
  • Immunosuppressant treatment.
  • Concurrent cancer, with the exceptions allowed by the principal investigator (PI).
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Please refer to this study by its identifier: NCT01413295

Hospital Clínic Barcelona
Barcelona, Spain, 08036
Sponsors and Collaborators
Fundacion Clinic per a la Recerca Biomédica
Principal Investigator: Ramon Vilella, PhD Fundació Clinic Recerca Biomédica
  More Information

Responsible Party: Ramon Vilella Puig, Senior consultant, Fundacion Clinic per a la Recerca Biomédica Identifier: NCT01413295     History of Changes
Other Study ID Numbers: MCBRVP
2009-017247-33 ( EudraCT Number )
TRA-082 ( Other Grant/Funding Number: Ministerio Ciencia e Innovación. SPAIN )
Study First Received: August 9, 2011
Last Updated: November 3, 2014

Keywords provided by Fundacion Clinic per a la Recerca Biomédica:
Colorectal Neoplasms
Dendritic Cells

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Immunologic Factors
Physiological Effects of Drugs processed this record on April 26, 2017