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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01123304
Recruitment Status : Terminated (This study has been terminated due to lack of availability of investigational product.)
First Posted : May 14, 2010
Last Update Posted : July 17, 2014
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Melanoma Drug: MORAb028 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : May 2010
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Experimental: MORAb 028 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.

Primary Outcome Measures :
  1. Safety of multiple intralesional administration of MORAb-028 [ Time Frame: 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 :
  1. Maximum tolerated dose of intralesional administration of MORAb-028 [ Time Frame: 22 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01123304

United States, California
John Wayne Cancer Institute
Santa Monica, California, United States, 90404
Sponsors and Collaborators
Study Director: Bruce Wallin, MD Morphotek

Responsible Party: Morphotek Identifier: NCT01123304     History of Changes
Other Study ID Numbers: MORAb028-002
First Posted: May 14, 2010    Key Record Dates
Last Update Posted: July 17, 2014
Last Verified: July 2014

Keywords provided by Morphotek:

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas