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Study With Dendritic Cell Immunotherapy in Resected Hepatic Metastasis of Colorectal Carcinoma
Conditions
Colorectal Carcinoma - Hepatic Metastasis
Conditions: official terms
Carcinoma - Colorectal Neoplasms - Liver Neoplasms - Neoplasm Metastasis
Conditions: Keywords
colorectal carcinoma, resectable hepatic metastasis, adjuvant treatment, dendritic cells
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Dendritic cells vaccine
Type: Drug
Overall Status
Recruiting
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
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
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
Locations
Clinica Universidad de Navarra
Pamplona, Navarra, Spain
Hospital de Navarra
Status: Recruiting
Pamplona, Navarra, Spain
Status: Recruiting
Start Date
November 2010
Completion Date
June 2014
Sponsors
Clinica Universidad de Navarra, Universidad de Navarra
Source
Clinica Universidad de Navarra, Universidad de Navarra
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page