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 cancer cells.

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a bone marrow sample (biopsy), an area of the hip bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle.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 drug.

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.