Multicenter phase II study of mitoguazone (MGBG) in relapsed or refractory AIDS-lymphoma (Meeting abstract).

Important note: Information in this article was accurate in 1995. The state of the art may have changed since the publication date.

Multicenter phase II study of mitoguazone (MGBG) in relapsed or refractory AIDS-lymphoma (Meeting abstract).

Proc Annu Meet Am Assoc Cancer Res; 14:A821 1995. Unique Identifier : AIDSLINE ICDB/95613973
Levine AM; Weiss GR; Tulpule A; Kaplan L; Giles F; Luskey BD; Scadden DT; Pearce T; Silverberg I; Busquets A; et al; USC School of Medicine, Los Angeles, CA

Abstract: Methyl-glyoxal-bis guanlhydrazone (MGBG) is a novel cytotoxic agent which interferes with polyamine biosynthesis, thought important in the stabilization of DNA. MGBG was used in the early 1980s given daily or weekly with responses seen in 29-40% in 'de novo' lymphoma although toxicity was significant. With a long T1/2, good penetration in CSF, and relative lack of marrow toxicity, we studied a dosing schedule of MGBG, 600 mg/m2 IV day 1, 8, then every 2 weeks. 30 male and 1 female patient with refractory or relapsed AIDS-lymphoma, with a median age of 41 yr (range 26-71) were accrued. Histologies include high grade B-cell immunoblastic in 13; small non cleaved in 12; high grade T-cell lymphoma in 1; and intermediate grade in 5. Median CD4 count was 83/mm3 (range 3-549/mm3); 84% of patients had a CD4 count less than 200/mm3. A median of 3+ doses of MGBG have been administered (range 1-30) thus far. Of the 25 patients evaluable for response to date, there have been 2 complete (8%) and 5 partial remissions (20%); in addition there has been one stable disease for over 10 months. Toxicities were mild and consisted of flushing (84%), mild mucositis (29%), fatigue/weakness (19%), and nausea/vomiting (19%). Thrombocytopenia was the only notable hematologic effect, noted in 16%. Clinical benefit has been observed in terms of weight gain (43%), improved performance status (33%), and improvement in CD4 cell counts (24%) in 21 patients evaluated to date. We conclude that MGBG is an active agent in treatment of relapsed or refractory AIDS-related lymphoma. The toxicity profile is mild, and quality of life appears to be positively impacted.

Keywords: CD4 Lymphocyte Count Half-Life Human Lymphoma, AIDS-Related/*DRUG THERAPY/IMMUNOLOGY/PATHOLOGY Mitoguazone/PHARMACOKINETICS/*TOXICITY/*THERAPEUTIC USE Recurrence Weight Gain ABSTRACT CLINICAL TRIAL MULTICENTER STUDY CLINICAL TRIAL, PHASE II
951230
M95C3226

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