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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 is a Phase 1 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 11 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00058799
The ClinicalTrials.gov registry entry for NCT00058799 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 11 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 3 interventions - of which Dose Level 1 is the first listed.
NCT00058799 reports 0 study locations.
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.
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