Lymphoma: MGBG New Studies, Compassionate Use in Earlier Disease

Results of two early trials of mitoguazone (MGBG) for advanced cases of AIDS lymphoma have encouraged investigators to study the drug in people with newly diagnosed lymphoma, and especially in those with lymphoma of the central nervous system. Susan Smith, a representative of MGBG's developer (ILEX, San Antonio, Texas, 210-667-8000), said the company could help pay expenses for people who qualify for the current trials but cannot afford to travel to one of 29 trial centers. People with AIDS lymphoma who do not qualify for the trials may be able to get MGBG on a compassionate use basis. ILEX hopes to submit the drug for FDA approval in mid-1996.

The two completed studies, headed by Alexandra M. Levine, M.D., of the University of Southern California in Los Angeles, found that more than 1 in 5 people who had failed therapy with one or more lymphoma treatments responded to MGBG. Another 1 in 5 had stable disease after MGBG treatment. Although that response rate is not high, the 56 people in the two studies had advanced disease. Complete responses to MGBG lasted for about 6.6 months. Dr. Levine, who presented her results on December 5 at the annual meeting of the American Society of Hematology in Seattle, said she and other investigators suspect that MGBG will be more effective in people with newly diagnosed AIDS lymphoma, especially if it is combined with other antilymphoma drugs.

MGBG had been studied earlier for non-AIDS lymphoma but had too many side effects. Dr. Levine and her co-investigators seem to have overcome that problem by lowering the dose to 600 mg/m(2) given intravenously over 30 minutes once a week for 2 weeks, then every 2 weeks. With that regimen, MGBG has only relatively mild adverse effects on the production of blood cells. That would be an important advantage for people with AIDS lymphoma, because many antilymphoma drugs, as well as drugs such as AZT, can hurt the production of new blood cells.