Modified Melanoma Vaccine for High Risk or Low Residual Disease Patients

Metastatic Disease Clinical Trial

Official title: Allogeneic Vaccine Modified to Express HLA A2/4-1BB Ligand for High Risk or Low Residual Disease Melanoma Patients

Status Not yet recruiting

Clinical Trial Summary

This study is based on the hypothesis that stimulation of the immune response against the tumor can help destroy residual tumor in melanoma patients with very high risk for disease recurrence and in patients with relatively low tumor burden who already got first line treatment for their disease.

Ongoing clinical trials in the Hadassah Hospital have shown that vaccination of patients with a cell line of tumor cells from the patient himself, or with a combination of three cell lines that partially match the patient's cell characteristics, could improve the immune response against the tumor, was associated with improved disease-free and overall survival.

In this study, the investigators will evaluate the efficacy of a modified tumor cell vaccine, in terms of immune response,improved disease-free and overall survival. The vaccine consists of a cell line that has a high expression level of melanoma molecules, and has been genetically modified to induce a strong immune response.

Clinical Trial Description

n/a

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• High Risk HLA-A2+ Melanoma
• Melanoma
• Metastatic Disease
• Neoplasm Metastasis

• NCT number: NCT01861938
• Study type: Interventional
• Source: Hadassah Medical Organization
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: June 2013