Randomized Trial With Dendritic Cells in Patients With Metastatic Colorectal Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ramon Vilella Puig, Fundacion Clinic per a la Recerca Biomédica
ClinicalTrials.gov Identifier:
NCT01413295
First received: August 9, 2011
Last updated: February 5, 2014
Last verified: February 2014

August 9, 2011
February 5, 2014
August 2011
April 2014   (final data collection date for primary outcome measure)
Progression Free Survival [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01413295 on ClinicalTrials.gov Archive Site
Overall Survival [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Randomized Trial With Dendritic Cells in Patients With Metastatic Colorectal Cancer
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Colorectal Neoplasms
  • Drug: Dendritic Cell Vaccine
    Vaccination with autologous dendritic cells loaded with autologous tumor antigens
  • Other: Supportive treatment
    Supportive treatment after progression of the illness after 2 lines of chemotherapy
  • Experimental: Dendritic Cells Vaccine
    Dendritic Cells Vaccine after 2 lines of chemotherapy
    Intervention: Drug: Dendritic Cell Vaccine
  • Supportive treatment
    Supportive treatment after 2 lines of chemotherapy
    Intervention: Other: Supportive treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
76
December 2014
April 2014   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01413295
MCBRVP, 2009-017247-33, TRA-082
Yes
Ramon Vilella Puig, Fundacion Clinic per a la Recerca Biomédica
Fundacion Clinic per a la Recerca Biomédica
Not Provided
Principal Investigator: Ramon Vilella, PhD Fundació Clinic Recerca Biomédica
Fundacion Clinic per a la Recerca Biomédica
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP