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

This study is currently recruiting participants.
Verified October 2017 by Clinica Universidad de Navarra, Universidad de Navarra
Sponsor:
ClinicalTrials.gov Identifier:
NCT01348256
First Posted: May 5, 2011
Last Update Posted: October 24, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Clinica Universidad de Navarra, Universidad de Navarra
  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
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

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 ]

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

Estimated Enrollment: 58
Study Start Date: November 2010
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
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 University of Navarra
  More Information

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 ( EudraCT Number )
First Submitted: May 3, 2011
First Posted: May 5, 2011
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:
Carcinoma
Neoplasm Metastasis
Neoplasms, Second Primary
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
Vaccines
Immunologic Factors
Physiological Effects of Drugs