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NCT00078520 · ClinicalTrials.gov registry record · Phase 1
Treatment of B-CLL With Human IL-2 and CD40 Ligand and Plasmid Gene Modified Autologous Tumor Cells
A Phase 1 study, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT00078520 is a Phase 1 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 9 participants.
The verdict
NCT00078520, a Phase 1 study, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
This study is for patients that have chronic lymphocytic leukemia (CLL). This research study aims to determine the safety and dosage of special cells that may make the patients own immune system fight the cancer. To do this, we will put a special gene into cancer cells that have been taken from the patients body. This will be done in the laboratory. This gene will make the cells produce interleukin 2 (IL-2), which is a natural substance that may help the immune system kill cancer cells. Additionally, we will stimulate the cancer cells with another natural protein called CD40 ligand (CD40L), which experiments in animal and human cells in vitro demonstrated can help IL-2 perform better. Some of these cells will then be put back into the patient's body. Studies of cancers in animals and in cancer cells that are grown in laboratories suggest that combining substances like IL-2 and CD40L helps the body kill cancer cells. An experimental treatment similar to this has already been used in children and similar experimental treatments are being used in adults with other cancers.
Interventions
- BIOLOGICAL Dose Level 1
- BIOLOGICAL Dose Level 2
- BIOLOGICAL Dose Level 2- Fixed Dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2003-01 |
| Est. Completion | 2010-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00078520
The ClinicalTrials.gov registry entry for NCT00078520 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 9 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.
NCT00078520 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00078520 about?
NCT00078520 is a clinical study titled "Treatment of B-CLL With Human IL-2 and CD40 Ligand and Plasmid Gene Modified Autologous Tumor Cells". This study is for patients that have chronic lymphocytic leukemia (CLL). This research study aims to determine the safety and dosage of special cells that may make the patients own immune system fight the cancer. To do this, we will put a special gene into cancer cells that have been taken from the...
What is the current status of trial NCT00078520?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2003-01. Estimated completion is 2010-03.
What interventions are being tested in trial NCT00078520?
The interventions under investigation include: Dose Level 1 (BIOLOGICAL), Dose Level 2 (BIOLOGICAL), Dose Level 2- Fixed Dose (BIOLOGICAL).
Who is sponsoring clinical trial NCT00078520?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
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