Pretreatment Anti-Therapeutic Antibodies (PATA) in Patients Treated With hu14.18K322A Antibody

November 4, 2020 updated by: St. Jude Children's Research Hospital

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

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Tennessee
  - Memphis, Tennessee, United States, 38105
    - St. Jude Children's Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

ADULT
OLDER_ADULT
CHILD

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants will have a diagnosis within the Ewing family of tumors, melanoma, neuroblastoma, or osteosarcoma and will receive treatment with hu14.18K322A.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Study Participants Those who meet eligibility criteria and consent to participate in the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characterization of PATA Time Frame: Once at participant enrollment	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 Time Frame: Once, at enrollment	Objective: To determine if PATA increases the anti-tumor efficacy of anti-GD2 antibodies in vitro	Once, at enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Jude Children's Research Hospital

Collaborators

University of Wisconsin, Madison

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2014

Primary Completion (Actual)

October 22, 2019

Study Completion (Actual)

April 24, 2020

Study Registration Dates

First Submitted

June 5, 2014

First Submitted That Met QC Criteria