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CompletedNCT02159443Updated Nov 5, 2020

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

An observational study in Ewing Family of Tumors, Melanoma and Neuroblastoma, sponsored by St. Jude Children's Research Hospital. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2020-11-05.

Primary conditionNeuroblastomaRegistry: Neuroectodermal Tumors, Primitive, PeripheralReclassifiedWhy we changed it
Registry
Neuroectodermal Tumors, Primitive, Peripheral — the first condition term the registry derived for this study.
ClinicalTrials.gg
Neuroblastoma
Why
  1. The study's listed conditions name Neuroblastoma, a narrower term within Neuroectodermal Tumors, Primitive, Peripheral.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by St. Jude Children's Research Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
76
Sex
All
01

Study 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
Read the 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.

02

Conditions studied

  • Ewing Family of Tumors
  • Melanoma
  • Neuroblastoma
  • Osteosarcoma

Keywords

  • Hu14.18K322A
  • Human anti-human antibodies (HAHA)
  • Pretreatment anti-therapeutic antibodies (PATA)
03

In context

Neuroblastoma Reclassified

675 studies on the registry are indexed under Neuroblastoma; 127 are open to participants now.

This study's enrollment of 76 is below the median of 123 across 84 observational studies indexed under Neuroblastoma.

Browse Neuroblastoma studies →

Lead sponsor

St. Jude Children's Research Hospital is the lead sponsor of 440 studies on the registry; 102 are open to participants now.

Of its 61 completed or terminated interventional studies of FDA-regulated products, 37 (61%) have results posted.

Browse St. Jude Children's Research Hospital studies →

Compared within Neuroblastoma, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Neuroectodermal Tumors, Primitive, Peripheral. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • All participants who have or will receive treatment at SJCRH with hu14.18K322A.

Exclusion criteria

Exclusion Criteria:

  • Those not receiving treatment at SJCRH with hu14.18K322A.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
76 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Study Participants

    Those who meet eligibility criteria and consent to participate in the study.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Once at participant enrollment

  2. Number of samples with increased anti-tumor efficacy

    Objective: To determine if PATA increases the anti-tumor efficacy of anti-GD2 antibodies in vitro

    Time frame: Once, at enrollment

07

Study locations

1 site
  • St. Jude Children's Research Hospital
    Memphis, Tennessee 38105, United States
08

References and documents

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2014 to primary completion in Oct 2019, 63 months.

Of 34 observational studies under Neuroblastoma, half reached primary completion within 213 months of starting (the median), counting those still running; a quarter within 74 and three quarters within 304. This study's 63 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 5, 2014
First posted
Jun 10, 2014
StartActual
Jul 15, 2014
Primary completionActual
Oct 22, 2019
CompletionActual
Apr 24, 2020
Last update
Nov 5, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02159443
Lead sponsor
St. Jude Children's Research Hospital
Collaborators
University of Wisconsin, Madison
Responsible party
Sponsor
First posted
Jun 10, 2014
Start date
Jul 15, 2014
Primary completion
Oct 22, 2019
Completion
Apr 24, 2020
Last update
Nov 5, 2020

Study contacts

Victor Santana, MD
principal investigator · St. Jude Children's Research Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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