Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00058799
Status:
COMPLETED
Last Update Posted:
2020-01-21
First Post:
2003-04-11
Brief Title:
Treating High Risk Leukemia With CD40 Ligand IL-2 Gene Modified Tumor Vaccine
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
Treatment of High Risk Acute Leukemia With CD40 Ligand and IL-2 Gene Modified Autologous Skin Fibroblasts and Tumor Cells
Status:
COMPLETED
Status Verified Date:
2020-01
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:
None
Brief Summary:
This research study is to determine the safety and dosage of special cells that may make the patients own immune system fight the leukemia To do this we will put special genes into cells called fibroblasts that we have grown in the laboratory from a skin sample The genes we put in these fibroblasts make them produce substances called CD40 Ligand CD40L and interleukin-2 IL-2 These are natural substances that may help the immune system kill leukemia cells Some of these fibroblasts producing CD40L and IL-2 mixed with a small quantity of the leukemic cells will then be put back into the body
Studies of cancers in animals and in cell lines suggest that substances like CD40L and IL-2 when mixed with cancer cells do help the body to recognize and kill these cancer cells A treatment using IL-2 has been previously used in more than 40 children with neuroblastoma and similar treatments are being used in adults with other cancers Some of the patients have shown significant tumor responses However we do not know if this treatment will work and we do not know the right amount of each of the special cells to use so different patients will get different combination and numbers of cells
The purpose of this study is to learn the side effects and safe dosage of these special cells
Studies of cancers in animals and in cell lines suggest that substances like CD40L and IL-2 when mixed with cancer cells do help the body to recognize and kill these cancer cells A treatment using IL-2 has been previously used in more than 40 children with neuroblastoma and similar treatments are being used in adults with other cancers Some of the patients have shown significant tumor responses However we do not know if this treatment will work and we do not know the right amount of each of the special cells to use so different patients will get different combination and numbers of cells
The purpose of this study is to learn the side effects and safe dosage of these special cells
Detailed Description:
Before starting in the treatment part of this study leukemia cells and skin fibroblasts will be collected from the patient - called procurement - to allow us to make the vaccine These leukemia cells are taken from either peripheral blood leukopheresis product or bone marrow The fibroblasts will be prepared in the laboratory with specially produced human viruses adenoviruses that carry the IL-2 or the CD40L gene The viruses will drop off the genes inside the fibroblasts The CD40L and IL-2 genes are meant to help stimulate the immune system to fight the leukemia The modified fibroblasts will be injected with a number of leukemic cells under the skin All the cells will be irradiated before injection to stop them growing Patients will receive three shots Depending on the response patients may be able to have three additional shots
In order to collect the skin fibroblasts at the very beginning of the study and then during the study we will perform small skin biopsies In particular before the second shot and then again about 1 week later we will look for both the modified and leukemia cells that have been re-injected under the skin We will do this by taking a skin biopsy from the place where the cells were injected The area where the skin biopsy will be obtained will be sterilized and then numbed with a local acting agent The skin will be removed with a tissue punch which will cut a circle of approximately 14th of an inch into the skin The site where the skin was removed will be closed with suture tape or stitches The area will be covered with dry gauze and adhesive tape These tests are to see whether the shots are killing leukemia cells and to make sure leukemia cells are not growing at the injection site
To study how the immunity is working in the system we will take blood samples before first injection then weekly for 10 weeks on week 12 once a month for a year and then eventually once a year for fifteen years These samples will be approximately 1 tablespoons of blood which is considered a safe amount If the patient has additional injections blood will be drawn prior to each injection Additional office visits may be necessary
Also patients will need to have a bone marrow test before enrolling on the study and at week 12 If the patient is not responding they may have treatment with other chemotherapy or radiation Patients will need to come to the clinic on the days of blood drawing and to be seen at Texas Childrens Cancer CenterThe Methodist Hospital at weekly intervals for 10 weeks then every other week for 6 weeks and then monthly for a year Thereafter patients will either be seen in the clinic or contacted by one of the research staff working on this study once a year for 15 years Additional visits may be necessary
In order to collect the skin fibroblasts at the very beginning of the study and then during the study we will perform small skin biopsies In particular before the second shot and then again about 1 week later we will look for both the modified and leukemia cells that have been re-injected under the skin We will do this by taking a skin biopsy from the place where the cells were injected The area where the skin biopsy will be obtained will be sterilized and then numbed with a local acting agent The skin will be removed with a tissue punch which will cut a circle of approximately 14th of an inch into the skin The site where the skin was removed will be closed with suture tape or stitches The area will be covered with dry gauze and adhesive tape These tests are to see whether the shots are killing leukemia cells and to make sure leukemia cells are not growing at the injection site
To study how the immunity is working in the system we will take blood samples before first injection then weekly for 10 weeks on week 12 once a month for a year and then eventually once a year for fifteen years These samples will be approximately 1 tablespoons of blood which is considered a safe amount If the patient has additional injections blood will be drawn prior to each injection Additional office visits may be necessary
Also patients will need to have a bone marrow test before enrolling on the study and at week 12 If the patient is not responding they may have treatment with other chemotherapy or radiation Patients will need to come to the clinic on the days of blood drawing and to be seen at Texas Childrens Cancer CenterThe Methodist Hospital at weekly intervals for 10 weeks then every other week for 6 weeks and then monthly for a year Thereafter patients will either be seen in the clinic or contacted by one of the research staff working on this study once a year for 15 years Additional visits may be necessary
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