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Trial Title:
Study With Dendritic Cell Immunotherapy in Resected Hepatic Metastasis of Colorectal Carcinoma
NCT ID:
NCT01348256
Condition:
Colorectal Carcinoma
Hepatic Metastasis
Conditions: Official terms:
Carcinoma
Neoplasm Metastasis
Colorectal Neoplasms
Liver Neoplasms
Conditions: Keywords:
colorectal carcinoma
resectable hepatic metastasis
adjuvant treatment
dendritic cells
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Dendritic cells vaccine
Description:
Vaccination with autologous dendritic cells loaded with autologous tumor antigens
Arm group label:
Dendritic cells vaccine
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.
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Clinica Universidad de Navarra
Address:
City:
Pamplona
Zip:
31008
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Ignacio Melero, MD, PhD
Email:
Principal Investigator
Facility:
Name:
Hospital de Navarra
Address:
City:
Pamplona
Zip:
31008
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Ruth Vera, MD
Email:
Principal Investigator
Start date:
November 2010
Completion date:
December 2018
Lead sponsor:
Agency:
Clinica Universidad de Navarra, Universidad de Navarra
Agency class:
Other
Source:
Clinica Universidad de Navarra, Universidad de Navarra
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01348256
