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

Phase 1

Terminated

• Conditions: Melanoma
• Interventions: Drug: MORAb028

• Registration Number: NCT01123304
• Lead Sponsor: Morphotek

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-12
• Study First Submitted QC: 2010-05-13
• Study First Posted: 2010-05-14
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-16
• Last Update Posted: 2014-07-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MORAb 028	MORAb028	-

Primary Outcome Measures

Name	Time	Method
Safety of multiple intralesional administration of MORAb-028	Day 33	After each patient completes study treatment the patient is evaluated for dose limiting toxicities (DLTs) up to 1 week after their last dose (at day 33)

Secondary Outcome Measures

Name	Time	Method
Maximum tolerated dose of intralesional administration of MORAb-028	22 months

Trial Locations

Locations (1)

John Wayne Cancer Institute; 🇺🇸 Santa Monica, California, United States