Safety Study of Human IgM (MORAb-028) to Treat Metastatic Melanoma

A Phase 1 Clinical Trial of Intra-Tumoral Injection of Human IgM Monoclonal Antibody (MORAb-028) to the Ganglioside GD2 in Subjects With Injectable Metastatic Melanoma

This research is being done to find out the safety of MORAb-028 in subjects with metastatic melanoma.

Inclusion Criteria:

• Histologically confirmed AJCC Stage IIIB, IIIC or IV melanoma with injectable metastases (in transit, intradermal, or subcutaneous nodules)
• Tumor accessible to intra-tumoral injections
• Cumulative tumor volume great enough to accept MORAb-028 injections for a given dose level, based on intent to inject at a concentration of 1 mg/cm3

Exclusion Criteria:

• Are candidates for curative surgical excision or lymphadenectomy
• Prior non-surgical treatment within 4 weeks
• Known central nervous system (CNS) tumor involvement or metastases
• Hypersensitivity to MORAb-028