Text Size

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

May 3, 2011
May 6, 2013
November 2010
December 2013   (final data collection date for primary outcome measure)
Progression Free survival [ Time Frame: Progression free survival at 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01348256 on ClinicalTrials.gov Archive Site
Overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study With Dendritic Cell Immunotherapy in Resected Hepatic Metastasis of Colorectal Carcinoma
Randomized Phase II Study With Dendritic Cell Immunotherapy in Patients With Resected Hepatic Metastasis of Colorectal Carcinoma

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Colorectal Carcinoma
  • Hepatic Metastasis
Drug: Dendritic cells vaccine
Vaccination with autologous dendritic cells loaded with autologous tumor antigens
  • No Intervention: Observation
    Observation after standard treatment
  • Experimental: Dendritic cells vaccine
    Adjuvant treatment with dendritic cells vaccine after standard treatment
    Intervention: Drug: Dendritic cells vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
58
June 2014
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Ignacio Melero, MD, PHD +34 948 255 400 imelero@unav.es
Spain
 
NCT01348256
CD-2009-01, 2008-007795-23
No
Clinica Universidad de Navarra, Universidad de Navarra
Clinica Universidad de Navarra, Universidad de Navarra
Not Provided
Study Chair: Ignacio Melero, MDPhD Universidad de Navarra
Clinica Universidad de Navarra, Universidad de Navarra
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP