Trial Information

A Phase I Trial of a Dendritic Cell Activating Scaffold Incorporating Autologous Melanoma Cell Lysate (WDVAX) in Metastatic Melanoma Patients

After agreeing to participate you will be asked to undergo some screening tests or
procedures to confirm that you are eligible for the study. Many of these test and procedures
are likely to be part of regular cancer care and may be done even if it turns out that you
do not take part in the research study. If you have had some of these tests or procedures
recently, they may or may not have to be repeated. These procedures include: a medical
history, physical examination, performance status, assessment of your tumor and blood tests.

If these tests show that you are eligible to participate in the research study, you will be
referred to a study surgeon to prepare for the surgical removal of tumor tissue from which
your vaccine will be made. If, at the time of your surgery, the surgeons are not able to
obtain enough tumor cells for us to make your vaccine, then you will not be eligible to
participate in this research study. The surgery will be performed at Brigham and Women's
Hospital.

The total number of vaccines to be administered to each participant is four. Since we are
looking for the shortest amount of time between doses that can be administered safely
without severe or unmanageable side effects in participants that have melanoma, not everyone
who participates in this research study will be on the same dose schedule to receive the
vaccine. For example, some participants will receive the vaccine once a month for 4 doses,
the next group will receive the vaccine every three weeks for 4 doses and the final group
will receive the vaccine every two weeks for four doses. The schedule for your vaccination
will depend on the number of participants who have been enrolled in the study before you and
how well they have tolerated their doses.

Before each vaccination and then 24 hours after each vaccination you will have a physical
exam and you will be asked questions about your general health and specific questions about
any problems that you might be having and any medications you may be taking.

We will assess your tumor by CT scan and/or MRI before you start the vaccine, approximately
half-way through the vaccine schedule and then one month after completion of all four
vaccines. After that we will assess your tumor every three months.

We will monitor you for any side effects from the vaccine throughout all of the vaccine
administration and for one month following completion of vaccinations or until all side
effects are gone. We will assess your tumor again half-way through the vaccine
administrations, one month and three months after completing all four vaccinations and then
every three months after that. We will also continue to follow you to collect information
regarding any other therapies you receive after vaccination is complete to keep track of any
responses that you might have to other therapies in the future.

Further, we would like to keep track of your medical condition for the rest of your life. We
would like to do this by calling you on the telephone once a year to see how you are doing.
Keeping in touch with you and checking your condition every year helps us look at the long
term effects of the research study.

Because different groups of participants will receive their vaccinations at different times
(depending on when you are enrolled), we will provide you with your own calendar that is
specific to the scheduling of your vaccine administration and all of your clinic visits and
tests. The over-all schedule for the research study plan is described below.

If after completion of screening you are still eligible and the tumor collection for your
surgery has been successful then there will be about a three week time period for you to
recover from the surgery and for us to make your vaccine in our laboratory at DFCI.

As described above you will receive a total of four vaccinations. On the day you receive a
vaccination, you will first undergo blood tests, a brief physical exam and update of your
medical record. If you are still eligible ot proceed, one of the study surgeons will implant
the vaccine by first washing a small area on your arm, leg or torso with sterilizing soap.
Then they will make a small incision in your skin and create a small "pocket" between teh
upper layer of skin and the tissue underneath. Using sterile surgical tools they will slide
the vaccine "tablet" into this pocket and then use 2-3 stitches to close the incision. This
site will be covered with a sterile bandage and the surgeon will ask you to return the
following day so that he or she or one of the other study team members may check the vaccine
site.

Depending on when you are enrolled in the study, you will receive your vaccines either;
every 4 weeks, every 3 weeks or every 2 weeks for a total of 4 vaccines. We will be able to
tell you the schedule at the time that you are enrolled on the study. We will be able to
give you a copy of your study calendar after our laboratory has processed your tumor sample.

If there are enough tumor cells left over from your vaccine preparation, we will irradiate
them to kill them and give them to you as an injection under the skin at the time of your
first vaccination and your last vaccination. This injection will be given at a site
different from where the vaccinations are placed. This is called a "DTH test" and is one way
to help us monitor activity of your immune system.

If you receive this DTH test, we will perform a small skin biopsy called a "punch biopsy" of
the DTH injection site about 3-5 days following the second DTH injection (3-5 days following
the last vaccination).

If we can see a vaccine injection site reaction (redness, swelling, etc.) at the vaccination
site then we will also perform a punch biopsy of the vaccination site about 3-5 days
following vaccination Number 2 and Number 4.

If at any time during the course of the vaccinations or after you complete all four
vaccinations you have easily accessible tumor that shows signs of an inflammatory reaction
to the vaccine we may also biopsy the tumor. The purpose of this is for us to learn what
sort of cells from the immune system may become activated against the tumor when you ar
receiving vaccine or following vaccination.