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NCT00743496 · ClinicalTrials.gov registry record · Phase 1

A Phase I Trial Of The Humanized Anti-GD2 Antibody In Children And Adolescents With Neuroblastoma, Osteosarcoma, Ewing Sarcoma and Melanoma

A Phase 1 study, sponsored by St. Jude Children's Research Hospital.

Completed
Registry status
Phase 1
Development phase
50
Enrollment target

NCT00743496: Completed Phase 1 study, sponsored by St. Jude Children's Research Hospital.

NCT00743496 is a Phase 1 study that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 50 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00743496, a Phase 1 study, has completed, sponsored by St. Jude Children's Research Hospital.

COMPLETED
Registry status
Phase 1
Development phase
50 participants
Enrollment target

Study Summary

Relapsed and/or refractory neuroblastoma, osteosarcoma, Ewing sarcoma and melanoma are considered difficult to treat and cure. For this study we are testing the use of a new experimental (investigational) antibody called hu14.18K322A. GD2 is expressed on the surface of most of these tumor types. Two schedules of hu14.18K322A antibody will be evaluated in this study, (1) daily for four consecutive days schedule every 28 days and (2) once weekly for 4 weeks schedule every 28 days. Approximately 25-40 participants will be required to define the maximum tolerated dose for each schedule. Participants will continue on treatment for a maximum of 4 to 8 courses or until one or more of the criteria for off-treatment are met.

Interventions

  • BIOLOGICAL Anti-GD2 antibody

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2008-10-08
Est. Completion 2014-04-18
Phase Phase 1

What the finished NCT00743496 record still lists

NCT00743496 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower).

The record links to 0 conditions, and to 1 intervention - of which Anti-GD2 antibody is the first listed.

NCT00743496 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00743496 about?

NCT00743496 is a clinical study titled "A Phase I Trial Of The Humanized Anti-GD2 Antibody In Children And Adolescents With Neuroblastoma, Osteosarcoma, Ewing Sarcoma and Melanoma". Relapsed and/or refractory neuroblastoma, osteosarcoma, Ewing sarcoma and melanoma are considered difficult to treat and cure. For this study we are testing the use of a new experimental (investigational) antibody called hu14.18K322A. GD2 is expressed on the surface of most of these tumor types. Tw...

What is the current status of trial NCT00743496?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2008-10-08. Estimated completion is 2014-04-18.

What interventions are being tested in trial NCT00743496?

The interventions under investigation include: Anti-GD2 antibody (BIOLOGICAL).

Who is sponsoring clinical trial NCT00743496?

This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00743496's enrollment target sits among peer trials

50 973rd of 2000 higher than 984 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00743496, the US trial registry maintained by the National Library of Medicine. NCT00743496 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.