Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00062855
Status:
COMPLETED
Last Update Posted:
2012-10-29
First Post:
2003-06-17
Brief Title:
Using Gene Modified Neuroblastoma Cells for the Treatment of RelapsedRefractory Neuroblastoma
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
Phase I Study of Chemokine and Cytokine Gene Modified Autologous Neuroblastoma Cells for Treatment of RelapsedRefractory Neuroblastoma Using an Adenoviral Vector CYCHE
Status:
COMPLETED
Status Verified Date:
2012-10
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:
CYCHE
Brief Summary:
This research study is designed to determine the safety and dosage of special cells that may make a patients own immune system fight the cancer To do this we will put two special genes into cancer cells taken from the patients body The genes we put in make the cancer cells produce lymphotactin a natural substance that attracts immune system cells to the cancer and IL-2 a natural substance that may help the immune system kill cancer cells Some of these cells will then be put back in the patients body Studies of cancers in animals and in cancer cells that are grown in laboratories suggest that substances like lymphotactin and IL-2 help the body kill cancer cells A treatment similar to this has been used in ten children previously and similar treatments are being used in adults with other cancers
The purpose of this study is to learn the side effects and safe dosage of these special cells
The purpose of this study is to learn the side effects and safe dosage of these special cells
Detailed Description:
Neuroblastoma cells taken from the patient will be separated in the laboratory and two specially produced human viruses adenovirus that carry the lymphotactin and the IL-2 gene were put into the cells These lymphotactin and IL-2 genes are meant to help the immune system fight the cancer
The modified cancer cells will be injected under the patients skin There will be four shots The second and subsequent shots will have ten times as many cells producing lymphotactin as the first We do not know the best amount of special cells to use so different patients will get different numbers of cells
Before the second shot and then again about 2 weeks later we will remove some of the modified cells from the patients body and study them We will do this by removing a section of skin referred to as a skin biopsy at the place where the cells were injected This test will help us to see whether or not the modified cells are killing cancer cells
To study how the immunity is working in the patients system we will take blood samples prior to each injection two to four days after each injection and may repeat this 5-7 days after each injection if your doctor thinks that is necessary
After patients have received the first set of 4 injections a complete evaluation is performed to see how this research treatment is working If these evaluations look okay and if more injections are available patients will have the option to receive a second set of 4 injections If patients receive the second set of 4 injections they will again have blood samples taken after each injection
After injections stop all patients will have blood samples collected once a month for a year and then once a year for fifteen years
To see if this research treatment is working we will do CAT scans MRIs or bone scans these are different types of x-rays We will also take a bone marrow biopsy bone marrow will be removed by use of a needle so that it can be looked at under the microscope These tests will be done prior to treatment and again eight weeks later In addition if patients receive the second set of four injections these tests will be repeated at six months
The modified cancer cells will be injected under the patients skin There will be four shots The second and subsequent shots will have ten times as many cells producing lymphotactin as the first We do not know the best amount of special cells to use so different patients will get different numbers of cells
Before the second shot and then again about 2 weeks later we will remove some of the modified cells from the patients body and study them We will do this by removing a section of skin referred to as a skin biopsy at the place where the cells were injected This test will help us to see whether or not the modified cells are killing cancer cells
To study how the immunity is working in the patients system we will take blood samples prior to each injection two to four days after each injection and may repeat this 5-7 days after each injection if your doctor thinks that is necessary
After patients have received the first set of 4 injections a complete evaluation is performed to see how this research treatment is working If these evaluations look okay and if more injections are available patients will have the option to receive a second set of 4 injections If patients receive the second set of 4 injections they will again have blood samples taken after each injection
After injections stop all patients will have blood samples collected once a month for a year and then once a year for fifteen years
To see if this research treatment is working we will do CAT scans MRIs or bone scans these are different types of x-rays We will also take a bone marrow biopsy bone marrow will be removed by use of a needle so that it can be looked at under the microscope These tests will be done prior to treatment and again eight weeks later In addition if patients receive the second set of four injections these tests will be repeated at six months
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 |
|---|---|---|---|
| Cyche | None | None | None |