Treatment of B-CLL With Human IL-2 and CD40 Ligand and Plasmid Gene Modified Autologous Tumor Cells (CLIPA)
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.
|Leukemia Leukemia, B-Cell, Chronic||Biological: IL-2 AND HUMAN CD40 LIGAND PLASMID GENE MODIFIED AUTOLOGOUS TUMOR CELLS||Phase 1|
Baylor College of Medicine has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Treatment of Chronic Lymphocytic B-Leukemia (B-CLL) With Human IL-2 and CD40 Ligand and Plasmid Gene Modified Autologous Tumor Cells (CLIPA)|
- safety of injections of autologous malignant B cells from B-CLL patients, which have been modified to secrete hIL-2 and hCD40L. [ Time Frame: 12 weeks ]
- anti-tumor immune responses [ Time Frame: 15 years ]
- obtain preliminary data on the anti-tumor effects of this treatment regimen. [ Time Frame: 15 years ]
|Study Start Date:||January 2003|
|Study Completion Date:||March 2010|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
Biological: IL-2 AND HUMAN CD40 LIGAND PLASMID GENE MODIFIED AUTOLOGOUS TUMOR CELLS
Please refer to this study by its ClinicalTrials.gov identifier: NCT00078520
|United States, Texas|
|The Methodist Hospital|
|Houston, Texas, United States, 77030|
|Study Chair:||MALCOLM K BRENNER, MD||Baylor College of Medicine|