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NCT00085930 · ClinicalTrials.gov registry record · Phase 1
Blood T-Cells and EBV Specific CTLs Expressing GD-2 Specific Chimeric T Cell Receptors to Neuroblastoma Patients
A Phase 1 study of Neuroblastoma, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
- 1
- Study location
NCT00085930: Completed Phase 1 study of Neuroblastoma, sponsored by Baylor College of Medicine.
NCT00085930 is a Phase 1 study of Neuroblastoma that has completed, run by Baylor College of Medicine. The registered enrollment target is 19 participants, below the 239-participant average among 94 other Neuroblastoma trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00085930, a Phase 1 study of Neuroblastoma, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
- 1
- Study location
Study Summary
Patients have high-risk neuroblastoma, a form of cancer typically found in children. The patients previously participated in a gene transfer research study using special immune cells. This research study combines two different ways of fighting disease, antibodies and T cells. Antibodies are types of proteins that protect the body from bacterial and other infections. T cells, also called cytotoxic T lymphocytes or CTLs, are special infection-fighting blood cells that can kill some tumor cells. Both antibodies and T cells have been used to treat patients with cancers and while they have shown promise, they have not been strong enough to cure most patients. The antibody used in this study is called 14g2a. This antibody sticks to neuroblastoma cells because of a substance on the outside of these cells called GD2. 14g2a and other antibodies that bind to GD2 have been used to treat people with neuroblastoma. For this study 14g2a has been changed so that instead of floating free in the blood, it is now joined to T cells. When an antibody is joined to a T cell in this way it is called a chimeric receptor. T lymphocytes or CTLs can kill tumor cells but there normally are not enough of them to kill all tumor cells. Some researchers have taken T cells from a person's blood, grown more of them in the laboratory and then given them back to the patient. Sometimes an antibody or chimeric receptor is attached to these T cells to help them bind to tumor cells. These chimeric receptor-T cells seem to kill some of the tumor, but they don't last very long in the body and so the tumor eventually comes back. We have found that T cells that are also trained to recognize the virus that causes infectious mononucleosis, Epstein Barr Virus (EBV), can stay in the blood stream for many years. By joining the 14g2a antibody to the CTLs that recognize EBV, we believe we will make a cell that can last a long time in the body (because they are EBV-specific) and recognize and kill neuroblastoma cells
Primary Outcome
Listings of adverse events by patients will include the time to onset, the duration of each event, the severity of each event, and the relationship of the event to study therapy, whether it was a serious event, and whether it caused withdrawal.
Conditions Studied
Interventions
- BIOLOGICAL EBV specific CTLs
Study Locations (1)
Texas
- Texas Children's Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2003-04 |
| Est. Completion | 2025-08 |
| Phase | Phase 1 |
What the finished NCT00085930 record still lists
NCT00085930 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 239-participant average among 94 other Neuroblastoma trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Neuroblastoma appearing as the primary indexed condition, and to 1 intervention - of which EBV specific CTLs is the first listed.
NCT00085930 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT00085930 about?
NCT00085930 is a clinical study titled "Blood T-Cells and EBV Specific CTLs Expressing GD-2 Specific Chimeric T Cell Receptors to Neuroblastoma Patients". Patients have high-risk neuroblastoma, a form of cancer typically found in children. The patients previously participated in a gene transfer research study using special immune cells. This research study combines two different ways of fighting disease, antibodies and T cells. Antibodies are types of...
What is the current status of trial NCT00085930?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2003-04. Estimated completion is 2025-08.
What conditions does trial NCT00085930 study?
This clinical trial studies the following conditions: Neuroblastoma.
What interventions are being tested in trial NCT00085930?
The interventions under investigation include: EBV specific CTLs (BIOLOGICAL).
Who is sponsoring clinical trial NCT00085930?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00085930 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Neuroblastoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00085930's enrollment target sits among peer trials
19 75th of 94 higher than 19 of 94 other Neuroblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neuroblastoma 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.
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