Phase II Study of Alemtuzumab (Campath-1H) Monoclonal Antibody in Patients With Relapsed and Resistant Classical Hodgkin's Disease
Alemtuzumab is the type of drug known as a "monoclonal antibody". The antibody binds to a
specific protein (antigen) called CD52. CD52 is found on the surface of normal lymphocytes
and monocytes. When the antibody binds to the protein on the surface of the lymphocyte or
monocyte it causes the cell to die. The goal of the study is to learn if killing normal
lymphocytes and monocytes with alemtuzumab will result in regression (lessening) of the
Alemtuzumab is usually given by an infusion into a vein. However, in this study, it will be
given as an injection under-the-skin. This method of giving alemtuzumab is not approved by
the FDA. The purpose of giving the drug by injection under the skin is to decrease the side
effects observed with infusion by vein.
Before you can start treatment on this study, you will have what are called "screening
tests". These tests will help the doctor decide if you are eligible to take part in the
study. You will have a complete medical history and physical exam Blood (about 2
tablespoons) will be collected for routine tests. A bone marrow sample will be collected to
learn if your Hodgkin's lymphoma has spread to the bone marrow. To collect a bone marrow
sample (biopsy), an area of the hip bone is numbed with anesthetic and a small amount of
bone marrow is withdrawn through a large needle. A CT scan or MRI of the chest, abdomen
(stomach), and pelvis (waist area) will be done. You will also have a PET scan or a Gallium
scan to check on the status of the disease. You will be required to have a heart scan or an
echocardiogram to check how strong your heart muscle is. You will be asked about medications
that you are currently taking, including over-the-counter medications. Women who are able
to have children must have a negative blood pregnancy test.
If you are found to be eligible to take part in this study, you will receive alemtuzumab 3
times a week as an injection under the skin. Typically these injections will be given on
Monday, Wednesday, and Friday. Each dose will be divided into two injections to be given in
each thigh. You will be treated for 12 weeks in a row. The treatment doses will be given
by a nurse at M. D. Anderson in an outpatient setting. Before each injection, you may
receive Tylenol and/or Benadryl to decrease the risk of side effects caused by the study
During the 12-week treatment course, in addition to your study drug injections, you will
visit the clinic every 3 weeks for physical exam and routine blood tests (2 tablespoons
each). You will also have a blood test (1 tablespoonful) every week to find out if you
are having a certain type of viral infection (cytomegalovirus, called CMV). If your blood
tests show that your CMV blood levels are increasing, you may need treatment with anti-viral
antibiotics to control your viral infection. You doctor will also give you antibiotics to
take by mouth to prevent possible infections.
If the tumor grows during treatment or you experience any intolerable (very bad) side
effects, you will be taken off study and your doctor will discuss other treatment options
Within 3 weeks of the last dose of alemtuzumab, you will have a physical exam, routine blood
tests (2 tablespoons), CT scans of the chest, abdomen, and pelvis, and a bone marrow biopsy
(if needed). These tests will help show whether your tumor is shrinking after therapy. If
these tests show that your tumor is not growing, you will be placed on observation and your
tumor status will be checked up on every 3 months by repeating similar tests.
This is an investigational study. Alemtuzumab is FDA approved for the treatment of chronic
lymphocytic leukemia and is commercially available. However, the FDA has not approved
alemtuzumab for the treatment of Hodgkin's disease. Furthermore, the FDA has not approved
the injection of alemtuzumab under the skin for the treatment of cancer. A maximum of 35
patients will take part in this study. All will be enrolled at M. D. Anderson.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Patients With Response
Response assessment of 12 weeks Campath-1H: Complete Response (CR), Partial Response (PR), No Change or Progressive Disease.
After 12 weeks of therapy
Anas Younes, M.D.
UT MD Anderson Cancer Center
United States: Food and Drug Administration
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