Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00299728
Status:
COMPLETED
Last Update Posted:
2022-10-10
First Post:
2006-03-06
Brief Title:
NY-ESO-1 Protein With Montanide and CpG 7909 as Cancer Vaccine in Several Tumors
Sponsor:
Ludwig Institute for Cancer Research
Organization:
Ludwig Institute for Cancer Research
Study Overview
Official Title:
A Phase I Study Using Vaccination With NY-ESO-1 Recombinant Protein Mixed With CpG 7909 and Montanide ISA-51 VG in Patients With Cancers That Often Express NY-ESO-1
Status:
COMPLETED
Status Verified Date:
2022-10
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:
None
Brief Summary:
This is a Phase I open-label randomized study of NY-ESO-l protein with immune adjuvants CpG 7909 and Montanide ISA-51 VG in patients with tumors that often express NY-ESO-1
The vaccinations was to be administered subcutaneously every 3 weeks for 4 doses
Patients with any malignancy that is known to frequently express NY-ESO-1 were eligible regardless of whether antigen expression in the autologous tumor could be demonstrated or not by either PCR or immunohistochemistry
The primary objective of the study was to define safety
Secondarily the study was to evaluate whether patients developed a specific immunologic response to the NY-ESO-1 protein Blood samples were to be obtained at baseline prior to each vaccination one week after each vaccination and at the last study visit for the assessment of NY-ESO-1-specific CD4 and CD8 T cells Cytokine secretion by NY-ESO-1-specific CD8 and CD4 T cells as a measure of T cell activation was to be determined by FACS analysis In addition humoral immunity was to be determined by the presence of NY-ESO-1-specific antibodies which were to be assessed in all patients by ELISA
Disease status was to be assessed at baseline and 2-4 weeks after the fourth vaccination in patients with evaluable measurable and non-measurable disease
The vaccinations was to be administered subcutaneously every 3 weeks for 4 doses
Patients with any malignancy that is known to frequently express NY-ESO-1 were eligible regardless of whether antigen expression in the autologous tumor could be demonstrated or not by either PCR or immunohistochemistry
The primary objective of the study was to define safety
Secondarily the study was to evaluate whether patients developed a specific immunologic response to the NY-ESO-1 protein Blood samples were to be obtained at baseline prior to each vaccination one week after each vaccination and at the last study visit for the assessment of NY-ESO-1-specific CD4 and CD8 T cells Cytokine secretion by NY-ESO-1-specific CD8 and CD4 T cells as a measure of T cell activation was to be determined by FACS analysis In addition humoral immunity was to be determined by the presence of NY-ESO-1-specific antibodies which were to be assessed in all patients by ELISA
Disease status was to be assessed at baseline and 2-4 weeks after the fourth vaccination in patients with evaluable measurable and non-measurable disease
Detailed Description:
Subjects were to receive an investigational research cancer vaccine every 3 weeks for a total of 4 treatments It was given by injection underneath the skin in an extremity leg or arm A vaccine is a compound designed to strengthen the immune system the cells and substances that protect the body from infection and foreign matter to fight an illness such as infections or cancer This vaccine is called NY-ESO-1 protein NY-ESO-1 protein an antigen which is a compound that is recognized by the immune system is found in many cancers Proteins such as NY-ESO-1 and their fragments are the targets the immune system needs to recognize cancer cells If the immune system can recognize these antigens foreign substances it may be able to kill the cells that carry them NY-ESO-1 can be found at different stages of cancers and is likely to be expressed shown at some point in the lifecycle of these types of cancer that are eligible for this study Therefore this study tries to boost strengthen the immune system toward NY-ESO-1 protein regardless of whether it is found in your tumor or not
Since we do not know whether different doses of the NY-ESO-1 protein may result in varying degrees of immune stimulation we will be randomizing that is at the flip of a coin or in other words by chance You may receive either the lower dose of NY-ESO-1 protein 100 µg or the higher dose 400 µg
The NY-ESO-1 protein vaccine was to be mixed with 2 substances called adjuvants the full names are CPG 7909 and Montanide ISA-51 VG Adjuvants are substances to increase the vaccines ability to stimulate the immune system By adding two adjuvants to the vaccine it is hoped that the boosting of the immune system will be especially effective
It is important to understand that vaccines are only experimental investigational research for the treatment of cancer They are not approved by the Food and Drug Administration FDA as treatment Therefore they are only offered in clinical trials
All tests and treatments were performed as an outpatient
Since we do not know whether different doses of the NY-ESO-1 protein may result in varying degrees of immune stimulation we will be randomizing that is at the flip of a coin or in other words by chance You may receive either the lower dose of NY-ESO-1 protein 100 µg or the higher dose 400 µg
The NY-ESO-1 protein vaccine was to be mixed with 2 substances called adjuvants the full names are CPG 7909 and Montanide ISA-51 VG Adjuvants are substances to increase the vaccines ability to stimulate the immune system By adding two adjuvants to the vaccine it is hoped that the boosting of the immune system will be especially effective
It is important to understand that vaccines are only experimental investigational research for the treatment of cancer They are not approved by the Food and Drug Administration FDA as treatment Therefore they are only offered in clinical trials
All tests and treatments were performed as an outpatient
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