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.
To study how the modified cells are working in the body, we will take blood samples prior to
each shot, then every four weeks for six months after the last injection, and then 2 years
after the first injection.
The amount of blood that will be obtained for these tests is approximately 2-3
tablespoonfuls, which is considered to be a safe amount. If the patient has a central line
(an IV line that has been placed in a large blood vessel that is meant to be used for long
periods of time), the blood will be taken from it, so that extra "sticks" should not be
needed. Additional office visits may be necessary to obtain this blood. The maximum total
amount of blood to be collected from the patient is 78 tablespoons.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To measure adverse events of patients receiving prolonged immunization with an autologous B-CLL vaccine expressing CD40L and IL2
Malcolm K Brenner, MB, PhD
Center for Cell and Gene Therapy, Baylor College of Medicine
United States: Food and Drug Administration
|The Methodist Hospital||Houston, Texas 77030|