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

This study is currently recruiting participants.
Verified September 2017 by St. Jude Children's Research Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT02159443
First Posted: June 10, 2014
Last Update Posted: September 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
University of Wisconsin, Madison
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
  Purpose

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

Condition
Ewing Family of Tumors Melanoma Neuroblastoma Osteosarcoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Characterization of Pretreatment Anti-Therapeutic Antibodies (PATA) in Patients Treated With hu14.18K322A Antibody

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • 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

  • 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


Biospecimen Retention:   Samples With DNA
DNA from tumor tissue. Blood serum samples.

Estimated Enrollment: 100
Actual Study Start Date: July 15, 2014
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: July 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts
Study Participants
Those who meet eligibility criteria and consent to participate in the study.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02159443


Contacts
Contact: Victor Santana, MD 866-278-5833 referralinfo@stjude.org

Locations
United States, Tennessee
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Victor Santana, MD    866-278-5833    referralinfo@stjude.org   
Principal Investigator: Victor Santana, MD         
Sponsors and Collaborators
St. Jude Children's Research Hospital
University of Wisconsin, Madison
Investigators
Principal Investigator: Victor Santana, MD St. Jude Children's Research Hospital
  More Information

Additional Information:
Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT02159443     History of Changes
Other Study ID Numbers: PATA
First Submitted: June 5, 2014
First Posted: June 10, 2014
Last Update Posted: September 19, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by St. Jude Children's Research Hospital:
Hu14.18K322A
Human anti-human antibodies (HAHA)
Pretreatment anti-therapeutic antibodies (PATA)

Additional relevant MeSH terms:
Neuroblastoma
Osteosarcoma
Sarcoma, Ewing
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Sarcoma
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs