Randomized Trial With Dendritic Cells in Patients With Metastatic Colorectal Cancer

NCT ID: NCT01413295

Last Updated: 2014-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2014-09-30

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.

Conditions

Colorectal Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dendritic Cells Vaccine

Dendritic Cells Vaccine after 2 lines of chemotherapy

Group Type: EXPERIMENTAL

Dendritic Cell Vaccine

Intervention Type: DRUG

Vaccination with autologous dendritic cells loaded with autologous tumor antigens

Supportive treatment

Supportive treatment after 2 lines of chemotherapy

Group Type: OTHER

Supportive treatment

Intervention Type: OTHER

Supportive treatment after progression of the illness after 2 lines of chemotherapy

Interventions

Dendritic Cell Vaccine

Vaccination with autologous dendritic cells loaded with autologous tumor antigens

Intervention Type: DRUG

Supportive treatment

Supportive treatment after progression of the illness after 2 lines of chemotherapy

Intervention Type: OTHER

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundacion Clinic per a la Recerca Biomédica

OTHER

Sponsor Role: lead

Responsible Party

Ramon Vilella Puig

Senior consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ramon Vilella, PhD

Role: PRINCIPAL_INVESTIGATOR

Fundació Clinic Recerca Biomédica

Locations

Hospital Clínic Barcelona

Barcelona, Barcelona, Spain

Countries

Spain

Other Identifiers

2009-017247-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

TRA-082

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

MCBRVP

Identifier Type: -

Identifier Source: org_study_id