Back to resultsStudy With Dendritic Cell Immunotherapy in Resected Hepatic Metastasis of Colorectal Carcinoma
Primary Purpose
Colorectal Carcinoma, Hepatic Metastasis
Status
Unknown status
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Dendritic cells vaccine
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Carcinoma focused on measuring colorectal carcinoma, resectable hepatic metastasis, adjuvant treatment, dendritic cells
Eligibility Criteria
Inclusion Criteria:
- Age over 18 years.
- Confirmed diagnosis of colorectal cancer with hepatic metastasis, amenable for surgical treatment.
- Capacity of understanding and signing the informed consent and to undergo the study procedures
- Availability of tumor tissue, for maturing dendritic cells
- Adequate renal, hepatic and bone marrow function
Exclusion Criteria:
- Clinically relevant diseases or infections.
- Concurrent participation in other clinical trial or administration or other antitumoral treatment
- Concurrent cancer, with the exceptions allowed by the principal investigator (PI).
- Pregnant or breast feeding women
- Immunosuppressant treatment
Sites / Locations
- Clinica Universidad de NavarraRecruiting
- Hospital de NavarraRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Observation
Dendritic cells vaccine
Arm Description
Observation after standard treatment
Adjuvant treatment with dendritic cells vaccine after standard treatment
Outcomes
Primary Outcome Measures
Progression Free survival
Secondary Outcome Measures
Overall survival
Full Information
NCT ID
NCT01348256
First Posted
May 3, 2011
Last Updated
October 23, 2017
Sponsor
Clinica Universidad de Navarra, Universidad de Navarra
1. Study Identification
Unique Protocol Identification Number
NCT01348256
Brief Title
Study With Dendritic Cell Immunotherapy in Resected Hepatic Metastasis of Colorectal Carcinoma
Official Title
Randomized Phase II Study With Dendritic Cell Immunotherapy in Patients With Resected Hepatic Metastasis of Colorectal Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 2010 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinica Universidad de Navarra, Universidad de Navarra
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Carcinoma, Hepatic Metastasis
Keywords
colorectal carcinoma, resectable hepatic metastasis, adjuvant treatment, dendritic cells
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Observation
Arm Type
No Intervention
Arm Description
Observation after standard treatment
Arm Title
Dendritic cells vaccine
Arm Type
Experimental
Arm Description
Adjuvant treatment with dendritic cells vaccine after standard treatment
Intervention Type
Drug
Intervention Name(s)
Dendritic cells vaccine
Intervention Description
Vaccination with autologous dendritic cells loaded with autologous tumor antigens
Primary Outcome Measure Information:
Title
Progression Free survival
Time Frame
Progression free survival at 2 years
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age over 18 years.
Confirmed diagnosis of colorectal cancer with hepatic metastasis, amenable for surgical treatment.
Capacity of understanding and signing the informed consent and to undergo the study procedures
Availability of tumor tissue, for maturing dendritic cells
Adequate renal, hepatic and bone marrow function
Exclusion Criteria:
Clinically relevant diseases or infections.
Concurrent participation in other clinical trial or administration or other antitumoral treatment
Concurrent cancer, with the exceptions allowed by the principal investigator (PI).
Pregnant or breast feeding women
Immunosuppressant treatment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ignacio Melero, MD, PHD
Phone
+34 948 255 400
Email
imelero@unav.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ignacio Melero, MDPhD
Organizational Affiliation
University of Navarra
Official's Role
Study Chair
Facility Information:
Facility Name
Clinica Universidad de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ignacio Melero, MD, PhD
Facility Name
Hospital de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruth Vera, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
30268156
Citation
Rodriguez J, Castanon E, Perez-Gracia JL, Rodriguez I, Viudez A, Alfaro C, Onate C, Perez G, Rotellar F, Inoges S, Lopez-Diaz de Cerio A, Resano L, Ponz-Sarvise M, Rodriguez-Ruiz ME, Chopitea A, Vera R, Melero I. A randomized phase II clinical trial of dendritic cell vaccination following complete resection of colon cancer liver metastasis. J Immunother Cancer. 2018 Sep 29;6(1):96. doi: 10.1186/s40425-018-0405-z.
Results Reference
derived
Learn more about this trial
Study With Dendritic Cell Immunotherapy in Resected Hepatic Metastasis of Colorectal Carcinoma
We'll reach out to this number within 24 hrs