Randomized Trial With Dendritic Cells in Patients With Metastatic Colorectal Cancer

NCT01413295 | Completed Phase 2 DMC

• 3 other identifiers: MCBRVP2009-017247-33TRA-082
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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

Keywords

Colorectal Neoplasms; Dendritic Cells

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  4 months

Secondary Outcomes (1)

• Overall Survival

  4 months

Study Arms (2)

Dendritic Cells Vaccine

EXPERIMENTAL

Dendritic Cells Vaccine after 2 lines of chemotherapy

Drug: Dendritic Cell Vaccine

Supportive treatment

OTHER

Supportive treatment after 2 lines of chemotherapy

Other: Supportive treatment

Interventions

Dendritic Cell Vaccine DRUG

Vaccination with autologous dendritic cells loaded with autologous tumor antigens

Dendritic Cells Vaccine

Supportive treatment OTHER

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

Supportive treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Fundacion Clinic per a la Recerca Biomédica: lead

Study Sites (1)

Hospital Clínic Barcelona

Barcelona, Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Ramon Vilella, PhD

  Fundació Clinic Recerca Biomédica

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior consultant

Study Record Dates

• First Submitted: August 9, 2011
• First Posted: August 10, 2011
• Study Start: August 1, 2011
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: November 4, 2014

Record last verified: 2014-11

Locations

ES (1)