Trial Information

Assessment of Circulating Tumor Cell Burden After Radiofrequency-Based Plasma Ablation (COBLATION®) in Conjunction With Vertebroplasty or Kyphoplasty for Augmenting Painful Vertebral Compression Fractures Secondary to Malignancy

Kyphoplasty and Vertebroplasty:

Kyphoplasty and vertebroplasty are types of surgery that are used to treat broken bones in
the back, which may have been caused by cancer. Both procedures involve injecting a mixture
of medical cement into the broken bone(s) in the back. The cement is designed to harden and
become a permanent part of the bone, supporting the bone like an "internal cast" that brings
it back to its original shape. The amount of cement will vary from person to person, but it
could be, for example, anywhere from a fraction of a teaspoon to a full teaspoon.

The main difference between the 2 procedures is that kyphoplasty involves the use of a small
medical type of balloon, and vertebroplasty does not use balloons. Vertebroplasty also uses
a slightly smaller needle to inject the cement.

The Study Device:

The Cavity SpineWand is a rod-shaped surgical tool that is designed to use a type of energy
called plasma in order to destroy tissue at lower temperatures than other surgical methods.
This may help to lessen damage to other nearby tissue.

In this study, the Cavity SpineWand will be used to remove tissue (soft tissue, bone tissue,
or both, but this will vary from person to person), including all or part of the cancerous
tumors in the area of the broken bone(s). This is designed to make extra room for the
cement to be injected, either during the vertebroplasty procedure or the kyphoplasty
procedure.

Screening Tests:

Before you can receive treatment in this study, you will have "screening tests" to help the
doctor decide if you are eligible to take part in this study. If you have had some of these
tests done recently, they may not need to be repeated. This will be up to your study
doctor. The following tests may be performed:

- Your medical history will be recorded.

- You will have a magnetic resonance imaging (MRI) scan and a computed tomography (CT)
scan. These scans will show pictures of your broken back bone(s) and the tumor. Your
doctor will use these pictures to plan your surgery.

Women who are able to have children must have a negative urine pregnancy test.

Doctors currently do not fully understand whether kyphoplasty or vertebroplasty is better
for treating broken bones in the back. For this reason, and because this study involves
randomly assigning participants to receive one or the other of these procedures, all
participants must be eligible for both procedures in order to take part in this study.

Treatment Groups:

If you are found to be eligible to take part in the study, you will be assigned to a
treatment group. In each phase of the study, there is an equal chance of being assigned to
any of the treatment groups.

If you are one of the first 20 patients enrolled in the study, you will be enrolled in Phase
1. You will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. Phase 1
Group 1 will receive vertebroplasty, and Phase 1 Group 2 will receive kyphoplasty.

If you are one of the next 60 patients to be enrolled, you will be enrolled in Phase 2. You
will be randomly assigned (as in the toss of dice) to 1 of 4 groups. Phase 2 Group 1 will
receive vertebroplasty, and Phase 2 Group 2 will receive vertebroplasty with the Cavity
SpineWand. Phase 2 Group 3 will receive kyphoplasty, and Phase 2 Group 4 will receive
kyphoplasty with the Cavity SpineWand.

Study Tests/Procedures Before Surgery:

Within about 2-4 weeks before surgery, you will have tests and procedures performed. If you
had some of these tests done recently, they may not need to be repeated. The following
procedures may be performed:

- Your medical history will be recorded.

- You will have a physical exam, including measurement of vital signs (blood pressure,
heart rate, temperature, and breathing rate).

- You will complete questionnaires that ask about the back pain and any drugs you are
taking. In total, the questionnaires should take about 10-20 minutes to complete.

- You will be asked to walk 50 feet at your own pace while being timed to see how long it
takes you. This is a routine test for comparing your walking function before and after
surgery.

You will sign a separate consent form for surgery and the drugs used during surgery. These
drugs include antibiotics to help lower the risk of infection, drugs to control pain, local
anesthesia to make the area of your back where you are having surgery feel numb, and a
sedative to make you feel relaxed and sleepy. The risks of these drugs will be explained to
you in detail at that time.

Blood Test on the Day of Surgery:

On the day of surgery, blood (about 1 tablespoon) will be drawn. This blood will be
compared with the blood that is drawn after surgery, to see when after surgery the most
tumor cells are found in the blood.

Other Procedures Before Surgery:

As is standard for these types of surgery, special "bone" needles will be placed into the
broken bone(s) in your back. X-rays will be used to guide the needles into a safe position.
A biopsy of the tumor in your back bone will be collected to check the diagnosis of cancer.
To collect a biopsy, a small amount of tumor tissue is withdrawn through the bone needle.

Surgical Procedures:

If you are in Phase 2 Group 2 or Phase 2 Group 4, the Cavity SpineWand will be used to
remove a small amount of tissue immediately before the kyphoplasty or vertebroplasty
procedure.

If you are in Phase 1 Group 2, Phase 2 Group 3, or Phase 2 Group 4, the kyphoplasty
procedure will be done next. A small balloon will be placed into the area in your back
where the tumor is located. Fluid will then be pumped through the tube in order to fill the
balloon, which will create a hole in the back bone. After the balloon is deflated (closed)
and removed, this hole will then be filled with cement. X-rays will be used to help place
the cement safely.

If you are in Phase 1 Group 1, Phase 2 Group 1, or Phase 2 Group 2, the vertebroplasty
procedure will be done next (instead of the kyphoplasty). Cement will be injected into the
back bone. X-rays will be used to help place the cement safely.

No matter which treatment group you are in, if you have more than 1 broken back bone that
needs treatment, the procedures described above will be repeated for a second broken bone,
right after your first procedure. In other words, if you had vertebroplasty performed
without the Cavity Spine Wand, that same procedure would be performed for the second bone.
The procedure would only be repeated this 1 additional time, and not a third time.

No matter which treatment you receive, the entire procedure should take about 2-3 hours. If
you need to have the procedure repeated on a second broken bone, this additional procedure
should add about 45 minutes to the 2-3 hours that the first procedure alone would have
taken.

Blood Testing for Phase 1 Participants:

Phase 1 participants will have blood (about 1 tablespoon each time) drawn at 8 different
times points in order to measure the number of tumor cells. This blood will be drawn at 10,
30, and 60 minutes, and then at 2 hours, and between 6-8 hours, 10-18 hours, 20-28 hours,
and 7 days after the surgery.

Blood Testing for Phase 2 Participants:

Phase 2 participants will have blood (about 1 tablespoon each time) drawn at 4 different
time points after surgery. The first and second blood draw will occur before 36 hours has
passed. The third blood draw will be about 36 hours after the surgery, and the fourth blood
draw will be about 7 days after the surgery. This blood will be tested to measure the
number of tumor cells.

Follow-Up Care:

You will be asked to return for follow-up visits at 7 days after your surgery and again at 4
weeks after your surgery. At these visits, the following tests and procedures will be
performed:

- You will have a physical exam, including measurement of vital signs.

- You will complete the questionnaires that ask about the back pain and any drugs you are
taking.

- You will be asked to walk a 50-foot distance, and your walk will be timed.

- At the Day 7 visit only, blood (about 1 tablespoon) will be drawn to measure the number
of tumor cells.

- At the Week 4 visit only, you will be asked to complete a questionnaire that asks you
to rate how satisfied you feel with the surgery. It should take about 10 minutes to
complete.

At 3 months after your surgery, the study staff will call you at home to ask about the back
pain and any drugs you may be taking.

Length of Study Participation:

After the Month 3 follow-up phone call, your active participation in this study will be
over. If it is determined after your surgery that the tumor in your back was not cancerous,
you would still return for the follow-up visits as is standard, but you would not need to
have the Day 7 blood test to measure the number of tumor cells.

This is an investigational study. The vertebroplasty and kyphoplasty procedures are
commercially available and FDA approved for the way they are being used in this study. The
Cavity SpineWand is also commercially available and FDA approved for the way it is being
used in this study. The research-specific part of this study is the blood testing to
measure any increases in the number of cancer cells in the blood.

Up to 100 patients will take part in this study. All will be enrolled at M. D. Anderson.