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Study With Dendritic Cell Immunotherapy in Resected Hepatic Metastasis of Colorectal Carcinoma

This study is currently recruiting participants.
Verified November 2012 by Clinica Universidad de Navarra, Universidad de Navarra
Sponsor:
Information provided by (Responsible Party):
Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier:
NCT01348256
First received: May 3, 2011
Last updated: May 6, 2013
Last verified: November 2012
History of Changes
  Purpose

In this randomized multicentric phase II study, patients with colorectal carcinoma with resectable hepatic metastasis will be randomized to treatment with dendritic cells or to observation, following conventional treatment with surgery and chemotherapy.


Condition Intervention Phase
Colorectal Carcinoma
Hepatic Metastasis
 Drug: Dendritic cells vaccine
 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 Study With Dendritic Cell Immunotherapy in Patients With Resected Hepatic Metastasis of Colorectal Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Clinica Universidad de Navarra, Universidad de Navarra:

Primary Outcome Measures:
  • Progression Free survival [ Time Frame: Progression free survival at 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 58
Study Start Date: November 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Observation
Observation after standard treatment
Experimental: Dendritic cells vaccine
Adjuvant treatment with dendritic cells vaccine after standard treatment
 Drug: Dendritic cells vaccine
Vaccination with autologous dendritic cells loaded with autologous tumor antigens

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age over 18 years.
  2. Confirmed diagnosis of colorectal cancer with hepatic metastasis, amenable for surgical treatment.
  3. Capacity of understanding and signing the informed consent and to undergo the study procedures
  4. Availability of tumor tissue, for maturing dendritic cells
  5. Adequate renal, hepatic and bone marrow function

Exclusion Criteria:

  1. Clinically relevant diseases or infections.
  2. Concurrent participation in other clinical trial or administration or other antitumoral treatment
  3. Concurrent cancer, with the exceptions allowed by the principal investigator (PI).
  4. Pregnant or breast feeding women
  5. Immunosuppressant treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01348256

Contacts
Contact: Ignacio Melero, MD, PHD +34 948 255 400 imelero@unav.es

Locations
Spain
Clinica Universidad de Navarra Recruiting
Pamplona, Navarra, Spain, 31008
Principal Investigator: Ignacio Melero, MD, PhD            
Hospital de Navarra Recruiting
Pamplona, Navarra, Spain, 31008
Principal Investigator: Ruth Vera, MD            
Sponsors and Collaborators
Clinica Universidad de Navarra, Universidad de Navarra
Investigators
Study Chair: Ignacio Melero, MDPhD Universidad de Navarra
  More Information

No publications provided

Responsible Party: Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier: NCT01348256     History of Changes
Other Study ID Numbers: CD-2009-01, 2008-007795-23
Study First Received: May 3, 2011
Last Updated: May 6, 2013
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Clinica Universidad de Navarra, Universidad de Navarra:
colorectal carcinoma
resectable hepatic metastasis
adjuvant treatment
dendritic cells

Additional relevant MeSH terms:
Carcinoma
Colorectal Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Liver Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
 Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Liver Diseases

ClinicalTrials.gov processed this record on June 18, 2013