We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT01348256
Recruitment Status : Unknown
Verified October 2017 by Clinica Universidad de Navarra, Universidad de Navarra.
Recruitment status was:  Recruiting
First Posted : May 5, 2011
Last Update Posted : October 24, 2017
Sponsor:
Information provided by (Responsible Party):
Clinica Universidad de Navarra, Universidad de Navarra

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Colorectal Carcinoma Hepatic Metastasis Drug: Dendritic cells vaccine Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase II Study With Dendritic Cell Immunotherapy in Patients With Resected Hepatic Metastasis of Colorectal Carcinoma
Study Start Date : November 2010
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Progression Free survival [ Time Frame: Progression free survival at 2 years ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 2 years ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01348256


Contacts
Layout table for location contacts
Contact: Ignacio Melero, MD, PHD +34 948 255 400 imelero@unav.es

Locations
Layout table for location information
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
Layout table for investigator information
Study Chair: Ignacio Melero, MDPhD University of Navarra
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier: NCT01348256    
Other Study ID Numbers: CD-2009-01
2008-007795-23 ( EudraCT Number )
First Posted: May 5, 2011    Key Record Dates
Last Update Posted: October 24, 2017
Last Verified: October 2017
Keywords provided by Clinica Universidad de Navarra, Universidad de Navarra:
colorectal carcinoma
resectable hepatic metastasis
adjuvant treatment
dendritic cells
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Neoplasm Metastasis
Colorectal Neoplasms
Liver Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplastic Processes
Pathologic Processes
Intestinal Neoplasms
 Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Liver Diseases