Pretreatment Anti-Therapeutic Antibodies (PATA) in Patients Treated With hu14.18K322A Antibody
| Status: | Recruiting |
|---|---|
| Conditions: | Skin Cancer, Cancer, Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 10/4/2018 |
| Start Date: | July 15, 2014 |
| End Date: | September 2019 |
| Contact: | Victor Santana, MD |
| Email: | referralinfo@stjude.org |
| Phone: | 866-278-5833 |
Characterization of Pretreatment Anti-Therapeutic Antibodies (PATA) in Patients Treated With hu14.18K322A Antibody
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
(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
In the proposed study, investigators will seek to determine the nature of this antibody that
is being detected in the HAHA test for this group of patients, and if, in the laboratory, it
increases the killing of tumor cells, accounting for the observation that some the patients
who tested positive may have an improved outcome.
The study will analyze DNA from blood samples of SJCRH patients treated with hu14.18K322A
anti-GD2 antibody. Serological studies and confirmatory genotyping studies will be performed
in a laboratory at the University of Wisconsin.
is being detected in the HAHA test for this group of patients, and if, in the laboratory, it
increases the killing of tumor cells, accounting for the observation that some the patients
who tested positive may have an improved outcome.
The study will analyze DNA from blood samples of SJCRH patients treated with hu14.18K322A
anti-GD2 antibody. Serological studies and confirmatory genotyping studies will be performed
in a laboratory at the University of Wisconsin.
Inclusion Criteria:
- All participants who have or will receive treatment at SJCRH with hu14.18K322A.
Exclusion Criteria:
- Those not receiving treatment at SJCRH with hu14.18K322A.
We found this trial at
1
site
262 Danny Thomas Pl
Memphis, Tennessee 38105
Memphis, Tennessee 38105
(901) 495-3300
Principal Investigator: Victor Santana, MD
Phone: 866-278-5833
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