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

• Status: Terminated
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Morphotek

Criteria

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