Short-Course EPOCH Chemotherapy and Rituximab for untreated HIV-associated non-Hodgkin's lymphoma

This study is designed to explore whether it is possible to achieve cure of HIV-associated non-Hodgkin's lymphoma by administering fewer than the usual number of chemotherapy treatments. A major problem is that HIV-infected patients often do not tolerate full dose treatment for non-Hodgkin's lymphoma. To prevent this problem, strategies that use lower doses of chemotherapy have been tested, but this has not resulted in longer survivals, partly because the lymphomas recur in many patients. Another strategy is to combine antiretroviral therapy with chemotherapy, but the cure rate has remained low with this strategy as well. The aim of the current clinical trial is to study the curative potential and immune effects of an experimental treatment which combines EPOCH chemotherapy and a lymphoma specific monoclonal antibody called rituximab. The study treatment differs from standard therapy in several ways. Some of the chemotherapy drugs are given by prolonged infusions over a 96-hour period, whereas standard chemotherapy is usually given over approximately 30 minutes. The rituximab, which has been approved for use in certain types of lymphoma, will be given with the chemotherapy. If the lymphoma becomes undetectable very early in treatment, only a total of 2 or 3 cycles of therapy will be given. However, if the lymphoma continues to be detectable, up to 6 cycles of treatment will be administered. With standard treatment, 6 to 8 cycles of chemotherapy are generally given. A cycle is the time from the administration of the chemotherapy drugs on one dosing episode until the next time the chemotherapy is given, and this is usually 3 weeks. Therefore, the 6 - 8 cycles of standard chemotherapy usually takes about 18 to 24 weeks to complete.

This study will test whether treatment can be safely stopped after 6 to 9 weeks.

For further information, contact Dr. Richard F. Little at 1-(800) 243-2732 and then press 4, or (301)402-6296 , or Dr. Wyndham H. Wilson at (301) 435-2415.