Prolonged Immunization With Autologous CD40 Ligand and IL-2-Expressing Tumor Cells for Treatment of B-Chronic Lymphocytic Leukemia (B-CLL)

Previously, some of the cancer cells taken from the patients body were separated in the laboratory and a specially produced human virus (adenovirus) that carries the IL-2 gene was put into the cells. Adenovirus is a common virus found in human respiratory systems. In its normal state, it can reproduce and cause a respiratory infection. Respiratory illnesses caused by adenovirus infections range from the common cold to pneumonia, croup and bronchitis. This adenovirus has been changed in the laboratory so that it is not likely to reproduce or cause an infection once it is in the patients body. The gene transfer method used in this study tries to add copies of the IL2 gene that increases the immune response against a tumor.

The rest of the cancer cells have been stimulated to express on their surface a substance called the human CD40L. These substances (IL-2 and CD40L), already naturally present in the patients body, are meant to help the immune system fight the cancer. In this study, the modified cancer cells will be injected under the skin. The patient will normally have the shots as an outpatient. The patient will receive the first eight (8) shots at 1-2 week intervals. They will then receive four (4) shots at 4 weekly intervals. After these first twelve shots, we will assess how the cancer is responding to these modified cells. If the cancer is not getting worse, the patient may receive an additional six (6) shots. These shots will again be given at 4 weekly intervals. In total, the patient may receive up to eighteen (18) shots over a period of one year. These shots must be given at the Methodist Hospital. Following these injections, the patient will be seen yearly for check-ups for 2 years after the first injection.

TESTS DURING AND AFTER EXPERIMENTAL TREATMENT:

A complete history and physical examination is necessary before the patient can be enrolled in the study. A physical examination will also be performed each time they are receive a shot of the modified cells. The place on the body where the patient has received their shots will be examined during the physical exam.

As mentioned above, the patient will then have yearly checkups for the 2 years after the first injection. After this, we will call the patients physician for updates on the patients health. These calls will be made annually until 5 years after the first injection.