Phase I/II study of iv recombinant platelet factor 4 (rPF4) in AIDS-related Kaposi's sarcoma (AIDS-KS) (Meeting abstract).

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

Phase I/II study of iv recombinant platelet factor 4 (rPF4) in AIDS-related Kaposi's sarcoma (AIDS-KS) (Meeting abstract).

Proc Annu Meet Am Assoc Cancer Res; 14:A820 1995. Unique Identifier : AIDSLINE ICDB/95613972
Northfelt DW; Robles R; Lang W; Wagner B; Kahn J; Bonnem E; University of California, San Francisco, CA

Abstract: Platelet factor 4, a normal constituent of platelet alpha granules, is an inhibitor of angiogenesis in several preclinical models. Previous studies showed that rPF4 was well-tolerated and effective in persons with AIDS-KS when given by intralesional injection in doses up to 5 mg. In these studies responses were seen at 6-8 weeks. A phase I/II study of iv rPF4 in persons with AIDS-KS has been initiated to assess safety and efficacy. Participants receive rPF4 at one of three dose levels (0.3, 1.0, or 3.0 mg/kg/d) over 6 hr/day for 5 days on alternating weeks. Standard safety and efficacy criteria are used in assessment. To date, 9 men with AIDS-KS (median age 36.5, median CD4 = 37/mm3) have been treated. Only minimal clinical toxicities, and no hematopoietic, hepatic, renal, or coagulation toxicities have been noted. Mild phlebitis developed at the infusion site in 5 patients. Seven have discontinued treatment by week 7 due to intercurrent illness or the desire to receive standard therapies. One has obtained a clinically meaningful response manifested by change in lesion character from nodular to macular, diminished lesion size, improved lesion color, and reduction in clinically significant leg edema. Updated information will be presented regarding participants recently accrued at the higher dose levels. Iv rPF4 is a tolerable and potentially effective anti-angiogenic therapy for AIDS-KS.

Keywords: Acquired Immunodeficiency Syndrome/*COMPLICATIONS Adult Human Infusions, Intravenous Male Platelet Factor 4/*TOXICITY/*THERAPEUTIC USE Recombinant Proteins/TOXICITY/THERAPEUTIC USE Sarcoma, Kaposi's/ETIOLOGY/*THERAPY ABSTRACT CLINICAL TRIAL CLINICAL TRIAL, PHASE I CLINICAL TRIAL, PHASE II
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M95C3227

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