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NCT00058799 · ClinicalTrials.gov registry record · Phase 1
Treating High Risk Leukemia With CD40 Ligand & IL-2 Gene Modified Tumor Vaccine
A Phase 1 study, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
NCT00058799: Completed Phase 1 study, sponsored by Baylor College of Medicine.
NCT00058799 is a Phase 1 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 11 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00058799, a Phase 1 study, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
Study Summary
This research study is to determine the safety and dosage of special cells that may make the patients own immune system fight the leukemia. To do this we will put special genes into cells called fibroblasts that we have grown in the laboratory from a skin sample. The genes we put in these fibroblasts make them produce substances called CD40 Ligand (CD40L) and interleukin-2 (IL-2). These are natural substances that may help the immune system kill leukemia cells. Some of these fibroblasts producing CD40L and IL-2 mixed with a small quantity of the leukemic cells will then be put back into the body. Studies of cancers in animals and in cell lines suggest that substances like CD40L and IL-2 when mixed with cancer cells do help the body to recognize and kill these cancer cells. A treatment using IL-2 has been previously used in more than 40 children with neuroblastoma and similar treatments are being used in adults with other cancers. Some of the patients have shown significant tumor responses. However, we do not know if this treatment will work and we do not know the right amount of each of the special cells to use, so different patients will get different combination and numbers of cells. The purpose of this study is to learn the side effects and safe dosage of these special cells.
Interventions
- BIOLOGICAL Dose Level 1
- BIOLOGICAL Dose Level 2
- BIOLOGICAL Dose Level 3
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 1999-06 |
| Est. Completion | 2010-06 |
| Phase | Phase 1 |
What the finished NCT00058799 record still lists
NCT00058799 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 3 interventions - of which Dose Level 1 is the first listed.
NCT00058799 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00058799 about?
NCT00058799 is a clinical study titled "Treating High Risk Leukemia With CD40 Ligand & IL-2 Gene Modified Tumor Vaccine". This research study is to determine the safety and dosage of special cells that may make the patients own immune system fight the leukemia. To do this we will put special genes into cells called fibroblasts that we have grown in the laboratory from a skin sample. The genes we put in these fibroblast...
What is the current status of trial NCT00058799?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 1999-06. Estimated completion is 2010-06.
What interventions are being tested in trial NCT00058799?
The interventions under investigation include: Dose Level 1 (BIOLOGICAL), Dose Level 2 (BIOLOGICAL), Dose Level 3 (BIOLOGICAL).
Who is sponsoring clinical trial NCT00058799?
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 NCT00058799's enrollment target sits among peer trials
11 1911th of 2000 higher than 88 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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