NY-ESO-1 Protein With Montanide and CpG 7909 as Cancer Vaccine in Several Tumors
This is a phase I, open-label, randomized study of NY-ESO-l protein with immune adjuvants CpG 7909 and Montanide® ISA-51 and NY-ESO-l protein 400µg with immune adjuvants CpG 7909 and Montanide® ISA-51 in patients with tumors that often express NY-ESO-1.
The vaccinations will be administered subcutaneously every 3 weeks for 4 doses.
Patients with any malignancy that is known to frequently express NY-ESO-1 will be eligible, regardless of whether antigen expression in the autologous tumor can be demonstrated or not by either PCR or immunohistochemistry.
The primary objective of the study is to define the safety.
Secondarily, the study will evaluate whether patients develop a specific immunologic response to the NY-ESO-1 protein. Blood samples will 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, will be determined by FACS analysis. In addition, humoral immunity will be determined by the presence of NY-ESO-1 specific antibodies which will be assessed in all patients by ELISA.
Disease status will be assessed at baseline and 2-4 weeks after the fourth vaccination in patients with evaluable (measurable and non-measurable disease).
Biological: NY-ESO-1 protein with CpG 7909 and Montanide
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study Using Vaccination With NY-ESO-1 Recombinant Protein Mixed With CpG7909 and Montanide® ISA-51 in Patients With Cancers That Often Express NY-ESO-1.|
- Immune response
- Anti-tumor response
|Study Start Date:||March 2006|
|Study Completion Date:||December 2006|
|Primary Completion Date:||December 2006 (Final data collection date for primary outcome measure)|
You will receive an investigational (research) cancer vaccine every 3 weeks for a total of 4 treatments. It is given by injection underneath your 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 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.) There is a 50:50 chance that you will receive the lower versus the higher dose. At this time we have no way of knowing whether there will be any real difference in the effects between these doses. In either case you will be receiving the NY-ESO-1 protein. In all studies to date, only the 100 µg dose has been used. There is no reason to think that the higher dose will be toxic, nor is there any reason at this time to think that the higher dose will be more effective at the immunological level, although it may be, which is the reason for comparing the effects of these two doses of protein.
The NY-ESO-1 protein vaccine is mixed with 2 substances, called adjuvants (the full names are: CPG 7909 and Montanide ISA-51). Adjuvants are substances to increase the vaccine's 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 will be performed as an outpatient.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00299728
|United States, New York|
|NYU Clinical Cancer Center|
|New York, New York, United States, 10016|
|NY Presbyterian- Columbia|
|New York, New York, United States, 10032|
|Principal Investigator:||Nina Bhardwaj, MD, PhD||New York University School of Medicine|
|Study Director:||Sylvia Adams, MD||New York University School of Medicine|
|Principal Investigator:||Gregory Mears, MD||Columbia University|