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
  Purpose

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
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 76
Study Start Date: August 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: April 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01413295

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

No publications provided

Responsible Party: Ramon Vilella Puig, Senior consultant, Fundacion Clinic per a la Recerca Biomédica
ClinicalTrials.gov Identifier: NCT01413295     History of Changes
Other Study ID Numbers: MCBRVP, 2009-017247-33, TRA-082
Study First Received: August 9, 2011
Last Updated: February 5, 2014
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

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

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on August 28, 2014