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.
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment
Nina Bhardwaj, MD, PhD
New York University School of Medicine
United States: Food and Drug Administration
|NYU Clinical Cancer Center||New York, New York 10016|
|NY Presbyterian- Columbia||New York, New York 10032|