Randomized Trial With Dendritic Cells in Patients With Metastatic Colorectal Cancer

Colorectal Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01413295
• Other study ID #: MCBRVP
• Secondary ID: 2009-017247-33TR
• Status: Completed
• Phase: Phase 2
• First received: August 9, 2011
• Last updated: November 3, 2014
• Start date: August 2011
• Est. completion date: September 2014

Study information

• Verified date: November 2014
• Source: Fundacion Clinic per a la Recerca Biomédica
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

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

Other:
• Supportive treatment
Supportive treatment after progression of the illness after 2 lines of chemotherapy

Locations

Country	Name	City	State
Spain	Hospital Clínic Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion Clinic per a la Recerca Biomédica

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival		4 months	No
Secondary	Overall Survival		4 months	No