Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00458679
Status:
COMPLETED
Last Update Posted:
2014-02-03
First Post:
2007-04-09
Brief Title:
Treatment of B-Chronic Lymphocytic Leukemia B-CLL With Autologous CD40 Ligand and IL-2-Expressing Tumor Cells
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
Prolonged Immunization With Autologous CD40 Ligand and IL-2-Expressing Tumor Cells for Treatment of B-Chronic Lymphocytic Leukemia B-CLL
Status:
COMPLETED
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRIMAL
Brief Summary:
We would like patients to be in a research study to determine the safety and effectiveness of special cells that may make their own immune system fight their 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 their immune system kill cancer cells Additionally we will stimulate the cancer cells with normal embryonic fibroblasts cells that develop into normal connective tissues in the body so that they will make another natural protein called CD40 ligand CD40L Studies of cancers in animals suggest IL-2 performs better when mixed with CD40L
Some of these cells will then be put back into the patients body with the goal that they will act like a vaccine and stimulate their immune system to attack the CLL cells Studies of cancers in animals and in cancer cells that are grown in laboratories suggest that combining substances like IL-2 and CD40L with cancer cells help the body recognize and kill cancer cells We have already conducted a study similar to this in patients with CLL In that study the subjects received about three months of injections shots In those subjects we saw some changes in the subjects immune system that might indicate that the modified cells were helping their immune system fight the cancer However in most of the subjects this change in the immune system went away after the injections were stopped
In this study we want to see if we can make the change in the immune system last longer by giving more injections over a longer period of time We hope that this might produce a better response directed at the CLL cells We will also be looking at the effect on cells called cancer stem cells which grow into the CLL cells we see in the blood Specifically this study will allow subjects to receive the injections for up to one year
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 their immune system kill cancer cells Additionally we will stimulate the cancer cells with normal embryonic fibroblasts cells that develop into normal connective tissues in the body so that they will make another natural protein called CD40 ligand CD40L Studies of cancers in animals suggest IL-2 performs better when mixed with CD40L
Some of these cells will then be put back into the patients body with the goal that they will act like a vaccine and stimulate their immune system to attack the CLL cells Studies of cancers in animals and in cancer cells that are grown in laboratories suggest that combining substances like IL-2 and CD40L with cancer cells help the body recognize and kill cancer cells We have already conducted a study similar to this in patients with CLL In that study the subjects received about three months of injections shots In those subjects we saw some changes in the subjects immune system that might indicate that the modified cells were helping their immune system fight the cancer However in most of the subjects this change in the immune system went away after the injections were stopped
In this study we want to see if we can make the change in the immune system last longer by giving more injections over a longer period of time We hope that this might produce a better response directed at the CLL cells We will also be looking at the effect on cells called cancer stem cells which grow into the CLL cells we see in the blood Specifically this study will allow subjects to receive the injections for up to one year
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PRIMAL | OTHER | BCM IRB | None |