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NCT01348256 Clinical Trial

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

Colorectal Carcinoma Clinical Trial

Official title:
Randomized Phase II Study With Dendritic Cell Immunotherapy in Patients With Resected Hepatic Metastasis of Colorectal Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01348256
Other study ID # CD-2009-01
Secondary ID 2008-007795-23
Status Recruiting
Phase Phase 2
First received May 3, 2011
Last updated October 23, 2017
Start date November 2010
Est. completion date December 2018

Study information
Verified date October 2017
Source Clinica Universidad de Navarra, Universidad de Navarra
Contact Ignacio Melero, MD, PHD
Phone +34 948 255 400
Email imelero@unav.es
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 58
Est. completion date December 2018
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Dendritic cells vaccine
Vaccination with autologous dendritic cells loaded with autologous tumor antigens

Locations
Country Name City State
Spain Clinica Universidad de Navarra Pamplona Navarra
Spain Hospital de Navarra Pamplona Navarra

Sponsors (1)
Lead Sponsor Collaborator
Clinica Universidad de Navarra, Universidad de Navarra

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Progression Free survival Progression free survival at 2 years
Secondary Overall survival 2 years
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