Immunotherapy for Colorectal Cancers Using CEA-Pulsed Dendritic Cells and Subsequent IL-2 Treatment

Colorectal Cancer Clinical Trial

Official title: A Phase I/II Clinical Study of Immunotherapy for Advanced Colorectal Cancers Using CEA-Pulsed Dendritic Cells Mixed With Tetanus Toxoid and Subsequent IL-2 Treatment

Status Recruiting

Clinical Trial Summary

The specific aims of this study are as follows:

1. Primary endpoint: to evaluate the clinical responses of vaccinated patients.

2. Secondary endpoint: to evaluate the safety of this treatment and the immune responses against CEA before and after the treatment

Clinical Trial Description

In this trial, we will immunize metastatic colorectal cancer patients with recombinant CEA-pulsed DCs mixed with tetanus toxoid by subcutaneous injection. Low dose IL-2 will be given subcutaneously following DC vaccination to boost the growth of T cells. We will adapt “Simon’s optimal two-stage design” for this study. In the first stage, we will treat 12 patients to evaluate the safety of this new protocol. If there are no severe toxicities/side effects and there is at least one patient that had stable disease or better clinical response, then we will proceed to the second stage and treat additional 25 patients. We will follow the clinical outcome of these 37 patients. The immune responses against CEA before and after vaccination will be examined. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

• NCT number: NCT00154713
• Study type: Interventional
• Source: National Taiwan University Hospital
• Contact: Wei-Lan Yu, R.N.
• Phone: 011-886-23123456
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: July 2005
• Completion date: July 2005