Safety Study of Human IgM (MORAb-028) to Treat Metastatic Melanoma
NCT ID: NCT01123304
Last Updated: 2014-07-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
18 participants
INTERVENTIONAL
2010-05-31
2012-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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MORAb 028
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Prior non-surgical treatment within 4 weeks
* Known central nervous system (CNS) tumor involvement or metastases
* Hypersensitivity to MORAb-028
18 Years
ALL
No
Sponsors
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Morphotek
INDUSTRY
Responsible Party
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Principal Investigators
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Bruce Wallin, MD
Role: STUDY_DIRECTOR
Morphotek
Locations
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John Wayne Cancer Institute
Santa Monica, California, United States
Countries
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Other Identifiers
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MORAb028-002
Identifier Type: -
Identifier Source: org_study_id
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