Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00431210
Status:
COMPLETED
Last Update Posted:
2017-04-18
First Post:
2007-02-02
Brief Title:
Epstein-Barr Virus-Specific Immunotherapy for Nasopharyngeal Carcinoma
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Pilot Feasibility Study of Epstein-Barr Virus-Specific Immunotherapy for Nasopharyngeal Carcinoma
Status:
COMPLETED
Status Verified Date:
2017-04
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:
The purpose of this study is to determine the safety of making and giving Epstein-Barr virus EBV immunotherapy products to subjects with nasopharyngeal carcinoma NPC associated with EBV that has come back or spread to other parts of the body EBV immunotherapy product is made with white blood cells from the participants body that are collected intravenously This EBV immunotherapy product may stop cancer cells from growing abnormally EBV immunotherapy products have been used in several research studies for NPC Information from these studies suggests the EBV immunotherapy products may stop the growth of NPC in some subjects
Detailed Description:
The first step in this research study is the peripheral blood collection Approximately 60-90ccs will be collected intravenously and used to prepare the EBV immunotherapy product It takes about 12 weeks to make the EBV immunotherapy product During this time the participant will receive standard of care as prescribed by their doctor
The EBV immunotherapy product will be made at a laboratory at the Connell OReilly Families Cell and Manipulation Core Facility at the Dana-Farber Cancer Institute The EBV immunotherapy product will contain T-cells that may react against your EBV-related tumor
A small amount of the EBV product will be used for research studies that will investigate components of the immune system that might be important in effective immunotherapy for NPC
EBV immunotherapy product will be given to the participant intravenously infusion on the first day of the research study Fourteen days later the participant will receive infusion 2 After infusion 2 the research doctor will do some tests to determine the effects that the EBV immunotherapy product has had on the tumor If the research doctor thinks the participant will benefit from a third infusion then they may receive one
Before each infusion of EBV immunotherapy product a physical examination and blood tests will be performed During the active treatment phase of this research study a physical exam and blood tests will be done every 1-2 weeks
Before each infusion of EBV immunotherapy product the research doctor may do a fiberoptic exam of the participants nasopharynx by using a flexible scop to visualize the tumor
At 8 weeks post-infusion we will evaluate the tumor by using a CT scan andor MRI We will also perform a PET or PETCT scan if the research doctor feels it is necessary We may do a chest CT scan to see if the tumor has spread to the lungs and an abdominalpelvic CT scan or MRI if the participant has symptoms that suggesting that there may be tumor in the liver or a bone scan to see if there is tumor in the bones
In addition to this study the research doctor may ask permission to participate in optional research studies We would like the participants permission to take a biopsy of the tumor after they have received infusion 2 The biopsy will be done by a surgeon who will review the risks of the procedure
The participant will return to the clinic for a follow-up visit where the response of the tumor will be evaluated blood tests and a physical exam will be performed at the following intervals for the first 2 months after the final infusion every 2-4 weeks for month 4 to month 12 after the final infusion every 2 months for the second year after the final infusion every 3 months
The EBV immunotherapy product will be made at a laboratory at the Connell OReilly Families Cell and Manipulation Core Facility at the Dana-Farber Cancer Institute The EBV immunotherapy product will contain T-cells that may react against your EBV-related tumor
A small amount of the EBV product will be used for research studies that will investigate components of the immune system that might be important in effective immunotherapy for NPC
EBV immunotherapy product will be given to the participant intravenously infusion on the first day of the research study Fourteen days later the participant will receive infusion 2 After infusion 2 the research doctor will do some tests to determine the effects that the EBV immunotherapy product has had on the tumor If the research doctor thinks the participant will benefit from a third infusion then they may receive one
Before each infusion of EBV immunotherapy product a physical examination and blood tests will be performed During the active treatment phase of this research study a physical exam and blood tests will be done every 1-2 weeks
Before each infusion of EBV immunotherapy product the research doctor may do a fiberoptic exam of the participants nasopharynx by using a flexible scop to visualize the tumor
At 8 weeks post-infusion we will evaluate the tumor by using a CT scan andor MRI We will also perform a PET or PETCT scan if the research doctor feels it is necessary We may do a chest CT scan to see if the tumor has spread to the lungs and an abdominalpelvic CT scan or MRI if the participant has symptoms that suggesting that there may be tumor in the liver or a bone scan to see if there is tumor in the bones
In addition to this study the research doctor may ask permission to participate in optional research studies We would like the participants permission to take a biopsy of the tumor after they have received infusion 2 The biopsy will be done by a surgeon who will review the risks of the procedure
The participant will return to the clinic for a follow-up visit where the response of the tumor will be evaluated blood tests and a physical exam will be performed at the following intervals for the first 2 months after the final infusion every 2-4 weeks for month 4 to month 12 after the final infusion every 2 months for the second year after the final infusion every 3 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