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

Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01123304
• Other study ID #: MORAb028-002
• Status: Terminated
• Phase: Phase 1
• First received: May 12, 2010
• Last updated: July 16, 2014
• Start date: May 2010
• Est. completion date: March 2012

Study information

• Verified date: July 2014
• Source: Morphotek
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma

Intervention

Drug:
• MORAb028
1 mg MORAb-028 will be injected at either 1 mg/cm3 per day over 5 days for a total dose of 5 mg for the first cohort and 2 mg/cm3 for the second cohort. Subjects will receive MORAb-028 injections on Days: 1-5, 8-12 and 22-26.

Locations

Country	Name	City	State
United States	John Wayne Cancer Institute	Santa Monica	California

Sponsors (1)

Lead Sponsor	Collaborator
Morphotek

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of multiple intralesional administration of MORAb-028	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)	Day 33	Yes
Secondary	Maximum tolerated dose of intralesional administration of MORAb-028		22 months	Yes