Randomized Phase II Trial in Patients With Progressive Stage IV Colorectal Cancer to Two Lines of Chemotherapy, in Order to Compare the Best Supportive Treatment Versus Treatment With Dendritic Cells Plus the Best Supportive Treatment
Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Colorectal Neoplasms
Both
Colorectal Neoplasms
Trial Information
Randomized Phase II Trial in Patients With Progressive Stage IV Colorectal Cancer to Two Lines of Chemotherapy, in Order to Compare the Best Supportive Treatment Versus Treatment With Dendritic Cells Plus the Best Supportive Treatment
Inclusion Criteria:
- 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 Criteria:
- 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).
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression Free Survival
Outcome Time Frame:
4 months
Safety Issue:
No
Principal Investigator
Ramon Vilella, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Fundació Clinic Recerca Biomédica
Authority:
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Study ID:
MCBRVP
NCT ID:
NCT01413295
Start Date:
August 2011
Completion Date:
August 2014
Related Keywords:
- Colorectal Neoplasms
- Colorectal Neoplasms
- Dendritic Cells
- Neoplasms
- Colorectal Neoplasms
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