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Randomized Trial With Dendritic Cells in Patients With Metastatic Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01413295
Recruitment Status : Completed
First Posted : August 10, 2011
Last Update Posted : November 4, 2014
Sponsor:
Information provided by (Responsible Party):
Ramon Vilella Puig, Fundacion Clinic per a la Recerca Biomédica

Study Description
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Brief 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.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : August 2011
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


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

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

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

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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01413295


Locations
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Spain
Hospital Clínic Barcelona
Barcelona, Spain, 08036
Sponsors and Collaborators
Fundacion Clinic per a la Recerca Biomédica
Investigators
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Principal Investigator: Ramon Vilella, PhD Fundació Clinic Recerca Biomédica
More Information
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Responsible Party: Ramon Vilella Puig, Senior consultant, Fundacion Clinic per a la Recerca Biomédica
ClinicalTrials.gov Identifier: NCT01413295    
Other Study ID Numbers: MCBRVP
2009-017247-33 ( EudraCT Number )
TRA-082 ( Other Grant/Funding Number: Ministerio Ciencia e Innovación. SPAIN )
First Posted: August 10, 2011    Key Record Dates
Last Update Posted: November 4, 2014
Last Verified: November 2014
Keywords provided by Ramon Vilella Puig, Fundacion Clinic per a la Recerca Biomédica:
Colorectal Neoplasms
Dendritic Cells
Additional relevant MeSH terms:
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Colorectal Neoplasms
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases