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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: Completed Phase 1 study, sponsored by Baylor College of Medicine.
NCT01713439 is a Phase 1 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The patients will be given four injections as per the protocol schedule with the evaluation at Week 8 (month 2). This will constitute a course and the evaluation of the dose limiting toxicity will be done during this course. Any patient having grade 4 toxicity or having progressive disease during the course will be considered a failure.
Interventions
- BIOLOGICAL Injection of allogeneic neuroblastoma cells
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 1997-12 |
| Est. Completion | 2016-04 |
| Phase | Phase 1 |
What the finished NCT01713439 record still lists
NCT01713439 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 1 intervention - of which Injection of allogeneic neuroblastoma cells is the first listed.
NCT01713439 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01713439's enrollment target sits among peer trials
32 1296th of 2000 higher than 679 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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