SAFETY AND BIOLOGIC EFFECTS OF DAB486IL-2 IN IL-2 RECEPTOR-EXPRESSING MALIGNANCIES (MEETING ABSTRACT)

Important note: Information in this article was accurate in 1992. The state of the art may have changed since the publication date.

SAFETY AND BIOLOGIC EFFECTS OF DAB486IL-2 IN IL-2 RECEPTOR-EXPRESSING MALIGNANCIES (MEETING ABSTRACT)

Proc Annu Meet Am Assoc Cancer Res; 33:A1358 1992. Unique Identifier : AIDSLINE ICDB/92683870
Kuzel T; Rosen S; Gordon L; Winter J; Samuelson E; Kaul K; Roenigk H; Nylen P; Woodworth T; Northwestern Univ., Chicago, IL 60611

Abstract: DAB486IL-2, a fusion protein of the diphtheria toxin (DT) A and B chain and IL-2, binds to the high-affinity IL-2 receptor (IL-2R) and blocks protein synthesis after internalization in IL-2R-expressing cells. We conducted a Phase I/II trial of this agent in 20 patients (pts; 10 mycosis fungoides [MF], 4 Hodgkin's, 4 non-Hodgkin's lymphomas [NHL], 1 HTLV-1-related T-cell lymphoma characterized by IL-2R expression, and 1 HIV+ Kaposi's sarcoma). Twelve doses (3 doses/day, each over 1 hr) were administered iv per cycle in escalating fashion: 3 pts 0.03 mg/kg, 3 pts 0.05 mg/kg, 4 pts 0.07 mg/kg and 10 pts 0.09 mg/kg. Dose-limiting toxicity consisted of 1 grade 4 and 8 asymptomatic grade 3 elevations in liver function tests at the 0.09-mg/kg level. Other toxicity included 1 grade 3 hypotension, 1 grade 3 retention of fluid, 8 pts with fevers, 7 pts with phlebitis at the iv site. Biologic activity was noted in the MF pts with skin lesion clearing; 1 pt with NHL had a partial response for 2 mo. The HIV+ pt had no change in CD-4+ cell numbers between baseline and day 22. Pharmacokinetics DT antibody (AB) and DAB486IL-2 AB titers were determined in all pts.

Keywords: Antibodies/ANALYSIS CD4-Positive T-Lymphocytes Diphtheria Toxin/ADVERSE EFFECTS/IMMUNOLOGY/*THERAPEUTIC USE Drug Evaluation Fever/CHEMICALLY INDUCED Hodgkin's Disease/*DRUG THERAPY Human Hypotension/CHEMICALLY INDUCED HIV Infections/COMPLICATIONS/*DRUG THERAPY Interleukin-2/ADVERSE EFFECTS/IMMUNOLOGY/*THERAPEUTIC USE Leukemia-Lymphoma, T-Cell, Acute, HTLV-I-Associated/*DRUG THERAPY Leukocyte Count Lymphoma, Non-Hodgkin's/*DRUG THERAPY Phlebitis/CHEMICALLY INDUCED Receptors, Interleukin-2/*METABOLISM Sarcoma, Kaposi's/*DRUG THERAPY/ETIOLOGY ABSTRACT CLINICAL TRIAL
921030
M92A1037

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