Status:
COMPLETED
Randomized Trial With Dendritic Cells in Patients With Metastatic Colorectal Cancer
Lead Sponsor:
Fundacion Clinic per a la Recerca Biomédica
Conditions:
Colorectal Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The different alternatives used since 1996 to treat metastatic colorectal cancer (MCRC) have increased the mean survival of these patients. This outstanding advance is due to the extended indications ...
Eligibility Criteria
Inclusion
- Age over 18 years.
- Capacity of understanding and signing the informed consent and to undergo the study procedures.
- Previously treated with 2 lines of chemotherapy.
- ECOG \<= 2.
- Adequate renal, hepatic and bone marrow function
- Confirmed diagnosis of colorectal cancer with hepatic metastasis, suitable for biopsy.
- Availability of tumor tissue, for maturing dendritic cells
- RECIST.1 criteria
Exclusion
- Clinically relevant diseases or infections (HBV, HCV, HIV).
- Pregnant or breast feeding women.
- Immunosuppressant treatment.
- Concurrent cancer, with the exceptions allowed by the principal investigator (PI).
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT01413295
Start Date
August 1 2011
End Date
September 1 2014
Last Update
November 4 2014
Active Locations (1)
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1
Hospital Clínic Barcelona
Barcelona, Barcelona, Spain, 08036