Back to resultsSafety Study of Human IgM (MORAb-028) to Treat Metastatic Melanoma
Primary Purpose
Melanoma
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MORAb028
Sponsored by
About this trial
This is an interventional treatment trial for Melanoma focused on measuring melanoma
Eligibility 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
Sites / Locations
- John Wayne Cancer Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MORAb 028
Arm Description
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Maximum tolerated dose of intralesional administration of MORAb-028
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01123304
Brief Title
Safety Study of Human IgM (MORAb-028) to Treat Metastatic Melanoma
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 Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Terminated
Why Stopped
This study has been terminated due to lack of availability of investigational product.
Study Start Date
May 2010 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Morphotek
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This research is being done to find out the safety of MORAb-028 in subjects with metastatic melanoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
Keywords
melanoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MORAb 028
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
MORAb028
Intervention Description
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 Measure Information:
Title
Safety of multiple intralesional administration of MORAb-028
Description
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)
Time Frame
Day 33
Secondary Outcome Measure Information:
Title
Maximum tolerated dose of intralesional administration of MORAb-028
Time Frame
22 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce Wallin, MD
Organizational Affiliation
Morphotek
Official's Role
Study Director
Facility Information:
Facility Name
John Wayne Cancer Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety Study of Human IgM (MORAb-028) to Treat Metastatic Melanoma
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