Clinical trial NCT01413295: Randomized Trial With Dendritic Cells in Patients With Metastatic Colorectal Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Neoplasms
Keywords: Colorectal Neoplasms
Dendritic Cells
Lead sponsor: Fundacion Clinic per a la Recerca Biomédica
Sponsor class: OTHER
First posted: 2011-08-10
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 for resection of hepatic metastases and to the use of new chemotherapeutic drugs (fluoropyrimidine, irinotecan and oxaliplatin) and monoclonal antibodies (bevacizumab, cetuximab and panitumumab). However, none of these treatments is curative and the majority of patients are overwhelmed by the illness. The first line of treatment for MCRC is FOLFOX and the second, irinotecan plus cetuximab for patients with wild type KRAS gene (60%) with a 30% responses, and bevacizumab plus irinotecan with a 5-10% of responses, in patients with mutated KRAS (40%). A treatment with autologous dendritic cells (DCs) pulsed with autologous tumour antigens is proposed as a third line of therapy. A randomized phase II trial would be performed, by selecting two groups of patients, one of them would be treated with the best supportive treatment and the other with DCs plus the best supportive treatment. The aim of the study would be to analyze the outcome after 4 months of treatment. In patients treated with DCs, IFN-γ spot forming cells and proliferative responses would be determined pre and post treatment in lymphocytes stimulated with autologous DCs pulsed with autologous tumour antigens. Pre and post treatment serum levels of IFN-γ, TNF-α, TGF-β e IL-12, would also be measured.


Eligibility criteria: 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).

Primary outcomes:
measure: Progression Free Survival
timeFrame: 4 months
Secondary outcomes:
measure: Overall Survival
timeFrame: 4 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clínic Barcelona
Study officials:
affiliation: Fundació Clinic Recerca Biomédica
name: Ramon Vilella, PhD
role: PRINCIPAL_INVESTIGATOR
References: