NCT01331915

Safety and Toxicity Study of Vaccination for Advanced Metastatic Melanoma Patients

Phase I/II Study of Therapeutic Vaccination With Escalating Doses of Theravac®, a Proteinic Vector Targeting Dendritic Cells Coupled to a Melanoma Antigen, in Patients With Advanced Metastatic Melanoma.

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 23 (estimated)
• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this phase I study, the investigators want to vaccine with THERAVAC® (an inactivated toxin coupled to melanoma antigen) some patients with advanced metastatic melanoma disease. The primary objective is to analyze the safety of the inreasing doses of vaccine. The secondary objective is to document whether this vaccine can induce tumor regression in immunized patients.

Detailed description

There are three treatment cohorts and the inclusion of patients in governed by the dose-limiting toxicities in the previous cohort. * the first three patients will receive a dose of 50 µg of Theravac® * second cohort of three patients will receive a dose of 150 µg Theravac® * the third cohort of three patients will receive a dose of 250 µg Theravac® and eventually a total of 14 patients will complete the step with the highest dose. All the patients will receive four immunizations every three weeks in two intradermal sites and in two subcutaneous sites.

Conditions

• Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	Theravac	Three groups with three doses (50 - 150 - 250 mcg), four times every three weeks. Injection: intradermally and subcutaneously.

Timeline

• Start date: 2010-09-01
• Primary completion: 2013-10-01
• First posted: 2011-04-08
• Last updated: 2012-10-10

Locations

1 site across 1 country: Belgium