Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00085930
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-05
First Post:
2004-06-17
Brief Title:
Blood T-Cells and EBV Specific CTLs Expressing GD-2 Specific Chimeric T Cell Receptors to Neuroblastoma Patients
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
Administration of Peripheral Blood T-Cells and EBV Specific CTLs Transduced to Express GD-2 Specific Chimeric T Cell Receptors to Patients With Neuroblastoma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
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:
NESTLES
Brief Summary:
Patients have high-risk neuroblastoma a form of cancer typically found in children The patients previously participated in a gene transfer research study using special immune cells This research study combines two different ways of fighting disease antibodies and T cells Antibodies are types of proteins that protect the body from bacterial and other infections T cells also called cytotoxic T lymphocytes or CTLs are special infection-fighting blood cells that can kill some tumor cells Both antibodies and T cells have been used to treat patients with cancers and while they have shown promise they have not been strong enough to cure most patients The antibody used in this study is called 14g2a This antibody sticks to neuroblastoma cells because of a substance on the outside of these cells called GD2 14g2a and other antibodies that bind to GD2 have been used to treat people with neuroblastoma For this study 14g2a has been changed so that instead of floating free in the blood it is now joined to T cells When an antibody is joined to a T cell in this way it is called a chimeric receptor T lymphocytes or CTLs can kill tumor cells but there normally are not enough of them to kill all tumor cells Some researchers have taken T cells from a persons blood grown more of them in the laboratory and then given them back to the patient Sometimes an antibody or chimeric receptor is attached to these T cells to help them bind to tumor cells These chimeric receptor-T cells seem to kill some of the tumor but they dont last very long in the body and so the tumor eventually comes back We have found that T cells that are also trained to recognize the virus that causes infectious mononucleosis Epstein Barr Virus EBV can stay in the blood stream for many years By joining the 14g2a antibody to the CTLs that recognize EBV we believe we will make a cell that can last a long time in the body because they are EBV-specific and recognize and kill neuroblastoma cells because an antibody that can recognize these cells has been placed on their surface Patients received treatment with the immune cells described above They may want to receive an additional dose of these cells This is being offered as an option because their neuroblastoma has returned and they have enough cells remaining to provide the patients with an additional dose These 14g2a antibody CTLs are an investigational product not approved by the Food and Drug Administration
Detailed Description:
Earlier the patient gave us blood to make 14g2a chimeric receptor-T cells and 14g2a chimeric receptor-EBV CTLs in the laboratory These cells were grown and frozen for the patient The patient received treatment with these cells However there are enough cells remaining that we are able to offer to treat the patient with an additional dose if they would like
As with the original treatment the patient will be given an injection of cells into the vein through and IV Before the injection is received the patient will be given a dose of Benadryl and Tylenol The injection will take about 2 minutes We will follow the patient in the clinic after the injection for 3 hours The treatment will be given by the Center for Cell and Gene Therapy at Texas Childrens Hospital
Medical tests before treatment--
Before being treated the patient will receive a series of standard medical tests
Physical exam
Blood tests to measure blood cells kidney and liver function
Measurements of tumor by scans and bone marrow studies if the bone marrow may show evidence of disease
Medical tests during and after treatment
The patient will receive standard medical tests when they are getting the infusions and after
Physical exams
Blood tests to measure blood cells kidney and liver function
Measurements of tumor by scans and bone marrow studies if the bone marrow had evidence of disease 6 weeks after each infusion
Because the patient has received cells with a new gene in them the patient will be followed for a total of 15 years to see if there are any long term side effects of gene transfer If they have a procedure related to their tumor for example a biopsy or tumor resection we will request permission to obtain a tissue sample This will help investigators learn more about T cell and CTL treatment of neuroblastoma In the event of death we will request permission to perform an autopsy to learn more about the effects of these infusions on the disease
As with the original treatment the patient will be given an injection of cells into the vein through and IV Before the injection is received the patient will be given a dose of Benadryl and Tylenol The injection will take about 2 minutes We will follow the patient in the clinic after the injection for 3 hours The treatment will be given by the Center for Cell and Gene Therapy at Texas Childrens Hospital
Medical tests before treatment--
Before being treated the patient will receive a series of standard medical tests
Physical exam
Blood tests to measure blood cells kidney and liver function
Measurements of tumor by scans and bone marrow studies if the bone marrow may show evidence of disease
Medical tests during and after treatment
The patient will receive standard medical tests when they are getting the infusions and after
Physical exams
Blood tests to measure blood cells kidney and liver function
Measurements of tumor by scans and bone marrow studies if the bone marrow had evidence of disease 6 weeks after each infusion
Because the patient has received cells with a new gene in them the patient will be followed for a total of 15 years to see if there are any long term side effects of gene transfer If they have a procedure related to their tumor for example a biopsy or tumor resection we will request permission to obtain a tissue sample This will help investigators learn more about T cell and CTL treatment of neuroblastoma In the event of death we will request permission to perform an autopsy to learn more about the effects of these infusions on the disease
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| NESTLES | OTHER | BCM CAGT | None |