Pretreatment Anti-Therapeutic Antibodies (PATA) in Patients Treated With hu14.18K322A Antibody
Characterization of Pretreatment Anti-Therapeutic Antibodies (PATA) in Patients Treated With hu14.18K322A Antibody
1 other identifier
observational
76
1 country
1
Brief Summary
Hu14.18K322A is a monoclonal antibody developed at St. Jude Children's Research Hospital (SJCRH) that is made to bind to cancer cells that have a molecule called GD2 on their surface. Sometimes the human body will make an antibody to the therapeutic antibody (like hu14.18K322A) that is being given for treatment. These are called human anti-human antibodies (HAHA). When testing for HAHA in a previous cohort of patients who received hu14.18K322A, it was found that some patients tested positive for high levels of an antibody before receiving hu14.18K322A or any other anti-GD2 antibody. In this study, investigators would like to know more about the nature of this pretreatment antibody, how often is it present, and if in the laboratory it increases the killing of tumor cells. OBJECTIVES:
- To determine whether pretreatment anti-therapeutic antibodies (PATA) represent antibodies reactive against an epitope (allotypic determinant) found on the anti-GD2 antibody hu14.18K322A
- To determine if PATA increases the anti-tumor efficacy of anti-GD2 antibodies in vitro
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2014
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2014
CompletedFirst Posted
Study publicly available on registry
June 10, 2014
CompletedStudy Start
First participant enrolled
July 15, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 22, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 24, 2020
CompletedNovember 5, 2020
November 1, 2020
5.3 years
June 5, 2014
November 4, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Characterization of PATA
Objective: To determine whether pretreatment anti-therapeutic antibodies (PATA) represent antibodies reactive against an epitope (allotypic determinant) found on the anti-GD2 antibody hu14.18K322A
Once at participant enrollment
Number of samples with increased anti-tumor efficacy
Objective: To determine if PATA increases the anti-tumor efficacy of anti-GD2 antibodies in vitro
Once, at enrollment
Study Arms (1)
Study Participants
Those who meet eligibility criteria and consent to participate in the study.
Eligibility Criteria
Participants will have a diagnosis within the Ewing family of tumors, melanoma, neuroblastoma, or osteosarcoma and will receive treatment with hu14.18K322A.
You may qualify if:
- All participants who have or will receive treatment at SJCRH with hu14.18K322A.
You may not qualify if:
- Those not receiving treatment at SJCRH with hu14.18K322A.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
Related Links
Biospecimen
DNA from tumor tissue. Blood serum samples.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Victor Santana, MD
St. Jude Children's Research Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2014
First Posted
June 10, 2014
Study Start
July 15, 2014
Primary Completion
October 22, 2019
Study Completion
April 24, 2020
Last Updated
November 5, 2020
Record last verified: 2020-11