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NCT01713439 · ClinicalTrials.gov registry record · Phase 1

Allogeneic Neuroblastoma Cells for Relapsed/ Refractory Neuroblastoma, CYCHEALL

A Phase 1 study, sponsored by Baylor College of Medicine.

Completed
Registry status
Phase 1
Development phase
32
Enrollment target

NCT01713439 is a Phase 1 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 32 participants.

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The verdict

NCT01713439, a Phase 1 study, has completed, sponsored by Baylor College of Medicine.

COMPLETED
Registry status
Phase 1
Development phase
32 participants
Enrollment target

Study Summary

The patient's have neuroblastoma that has come back, or not gone away. The cancer is harder to treat now. The investigators would like the patient's to be in this research study to determine the safety and dosage of special cells that may make the patient's own immune system fight the cancer. To do this the investigators will put two special genes into neuroblastoma cancer cells that have been grown in the lab. The genes put in make the cancer cells produce lymphotactin, a natural substance that attracts immune system cells to the cancer, and IL-2 a natural substance that may help the immune system kill cancer cells. Some of these cells will then be put into the patient's body. Studies of cancers in animals and in cancer cells that are grown in laboratories suggest that substances like lymphotactin and IL-2 do help the body kill cancer cells. A treatment similar to this has been used in twelve children previously and similar treatments are being used in adults with other cancers. This is a research study. The investigators do not know the best amount of special cells to use, so different children will get different numbers of cells. The purpose of this study is to learn the side effects and safe "dosage" of these special cells. Participation in this study will last for 15 years.

Interventions

  • BIOLOGICAL Injection of allogeneic neuroblastoma cells

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 1997-12
Est. Completion 2016-04
Phase Phase 1

Sponsor

Baylor College of Medicine

616 total trials

What the Registry Record Tells You About NCT01713439

The ClinicalTrials.gov registry entry for NCT01713439 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Injection of allogeneic neuroblastoma cells is the first listed.

NCT01713439 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01713439 about?

NCT01713439 is a clinical study titled "Allogeneic Neuroblastoma Cells for Relapsed/ Refractory Neuroblastoma, CYCHEALL". The patient's have neuroblastoma that has come back, or not gone away. The cancer is harder to treat now. The investigators would like the patient's to be in this research study to determine the safety and dosage of special cells that may make the patient's own immune system fight the cancer. To do ...

What is the current status of trial NCT01713439?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 1997-12. Estimated completion is 2016-04.

What interventions are being tested in trial NCT01713439?

The interventions under investigation include: Injection of allogeneic neuroblastoma cells (BIOLOGICAL).

Who is sponsoring clinical trial NCT01713439?

This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.