THE FRED HUTCHINSON CANCER RESEARCH CENTER AND THE 
UNIVERSITY OF WASHINGTON SCHOOL OF MEDICINE 
DEPARTMENT OF MEDICINE, DIVISION OF ONCOLOGY 
Consent to Participate in Allogeneic Bone Marrow Transplantation, Adoptive Immunotherapy with 
Genetically Modified HIV-specific Lymphocytes and the Administration of Zidovudine (AZT) for 
Patient with Malignant Lymphoma and Human Immunodeficiency Virus Infection. 
Investigators: S.R. Riddell, M.D., Assistant Member, FHCRC, 667-5249; P.D. Greenberg, M.D., Professor 
of Medicine and Immunology UW, Member FHCRC; R.W. Overell, Ph.D., Immunex Corporation, T.P. 
Loughran, M.D., Associate Member FHCRC; M.J. Gilbert, M.D., Senior Fellow, FHCRC; S.D. Lupton, 
Ph.D., Immunex Corporation; J.M. Agosti, M.D., Immunex Corporation, S. Scheeler, Immunex 
Corporation, R.W. Coombs, M.D., Assistant Professor of Medicine, UW, L. Corey, M.D., Professor of 
Laboratory Medicine/Medicine, UW. 
Emergency (24 hours) Phone: 667-5001 
Attending Physician Phone: 
BACKGROUND AND PURPOSE 
You have cancer of the lymph node cells (lymphoma) and an infection with the human immunodeficiency 
virus (HIV), the virus associated with the Acquired Immunodeficiency Syndrome (AIDS). Infection with HIV 
is often characterized by gradual impairment of the immune system leading to increased infections and an 
increased risk for the development of cancers, including lymphoma. Drug therapy such as zidovudine (AZT) 
may temporarily slow the progress of HIV infection, but the disease usually progresses to a fatal 
immunodeficiency. Lymphomas in patients with HIV infection are usually treated with chemotherapy or 
radiation therapy which may provide a temporary remission but recurrence of the cancer is common. 
This study is evaluating bone marrow transplantation as a therapy for both the lymphoma and HIV infection. 
In an attempt to prevent HIV infection of the donated bone marrow and destroy any residual HIV infected 
cells, we will administer the drug zidovudine (AZT) to you. We will also attempt to boost your immunity to 
HIV with a treatment called adoptive immunotherapy. 
Most patients infected with HIV initially develop some immunity to the virus provided by lymphocytes which 
specifically recognize and kill HIV infected cells. The presence of these lymphocytes in the body appears to 
help delay HIV spread and progression to AIDS. The chemotherapy and radiation therapy you will receive to 
destroy the lymphoma cells will also destroy your lymphocytes which provide this immunity to HIV. 
Therefore, we will attempt to isolate these specific lymphocytes that fight HIV from your blood before the 
bone marrow transplant and grow these cells to large numbers in the laboratory. These lymphocytes will be 
given back to you after the transplant in an attempt to provide immunity to HIV and prevent the virus from 
infecting the new immune system developing from the donated marrow. We will insert a gene into the 
lymphocytes to be used in immunotherapy to provide a sensitive indicator of the survival of these cells after 
giving them back to you. The process of genetically modifying the lymphocytes involves introducing genetic 
material from a mouse virus, a bacterial and a viral gene into the genetic material of the HIV-specific 
lymphocytes. Since this is a new experimental therapy, it is possible the transferred lymphocytes might cause 
side effects due to inflammation initiated when these transferred lymphocytes contact your residual HIV 
infected cells. Therefore, the viral gene inserted into the lymphocytes was selected to make a protein that 
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