Safety and Pharmacodynamic Study of a New Formulation, AGI - 101H Vaccine in the Treatment of Advanced Melanoma

Summary

In this open-label study of patients with advanced melanoma 20 evaluable patients will be recruited. The drug substance, AGI-101H, is a whole cell, allogeneic melanoma vaccine, representing a mixture (1:1 ratio) of two therapeutic gene modified human melanoma cell lines, referred to as Mich1H6 and Mich2H6, which has been gamma-irradiated to render the cells non-proliferative Patients will receive treatment for up to 26 weeks. Progression at any time point requiring systemic treatment with, for example with chemotherapy or cytokines will lead to withdrawal of this patient from the study. The dose chosen is 5 x 107 viable cells/dose.

Timeline

Start

2008-06

Primary completion

2009-12

Completion

2009-12

Outcome

Outcome not reported

Stopped (Business): “problems in funding”

Drugs

Indications