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

October 23, 2017 updated by: Clinica Universidad de Navarra, Universidad de Navarra

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

58

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ignacio Melero, MD, PHD
  • Phone Number: +34 948 255 400
  • Email: imelero@unav.es

Study Locations

  • Spain
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Recruiting
        • Clinica Universidad de Navarra
        • Principal Investigator:
          • Ignacio Melero, MD, PhD
      • Pamplona, Navarra, Spain, 31008
        • Recruiting
        • Hospital de Navarra
        • Principal Investigator:
          • Ruth Vera, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression Free survival
Time Frame: Progression free survival at 2 years
Progression free survival at 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Investigators

  • Study Chair: Ignacio Melero, MDPhD, University of Navarra

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

May 3, 2011

First Submitted That Met QC Criteria

May 4, 2011

First Posted (Estimate)

May 5, 2011

Study Record Updates

Last Update Posted (Actual)

October 24, 2017

Last Update Submitted That Met QC Criteria

October 23, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CD-2009-01
  • 2008-007795-23 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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