A Phase 1/2 study of recombinant platelet factor 4 (rPF4) in patients with AIDS-related Kaposi's sarcoma (KS) (Meeting abstract).

Important note: Information in this article was accurate in 1993. The state of the art may have changed since the publication date.

A Phase 1/2 study of recombinant platelet factor 4 (rPF4) in patients with AIDS-related Kaposi's sarcoma (KS) (Meeting abstract).

Proc Annu Meet Am Soc Clin Oncol; 12:A4 1993. Unique Identifier : AIDSLINE ICDB/93694404
Kahn J; Ruiz R; Kerschmann R; Berger T; Ma R; Coleman R; Alford BL; San Francisco General Hosp., San Francisco, CA 94110

Abstract: Kaposi's sarcoma remains a significant clinical problem for patients (pts) infected with HIV. Recently, rPF4 was cloned and expressed in E coli. rPF4 demonstrates inhibition of angiogenesis and inhibits the of growth KS cells in vitro. A Phase 1/2 study was begun to determine the safety and preliminary effectiveness of rPF4 administered via an intralesional route. 12 pts with KS were treated with doses ranging from 0.1 to 2.5 mg/lesion daily for 7 days then 3x/wk for 3 additional weeks. Each subject had two randomly selected lesions chosen for study and a prospective randomized, blinded administration of study drug or control was performed. Each pt had one lesion injected with rPF4 and one lesion injected with saline. No serious life-threatening adverse events occurred; 2 pts died of other AIDS-related events. Mild to moderate erythema was observed at the injection site in approx 20% of the pts. Of 12 pts injected, 6 pts demonstrated some anti-KS effects and all 3 pts at the highest dose demonstrated anti-KS effects. This Phase 1/2 study demonstrates the safety of rPF4 and it warrants further study in an expanded population of pts. This study represents the first time rPF4 was administered to humans, and suggests a biologic effect of this protein in AIDS-related KS.

Keywords: Acquired Immunodeficiency Syndrome/*THERAPY Dose-Response Relationship, Drug Drug Administration Schedule Human Injections, Intralesional Platelet Factor 4/*ADMINISTRATION & DOSAGE/ADVERSE EFFECTS Recombinant Proteins/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS Sarcoma, Kaposi's/*THERAPY Skin Neoplasms/*THERAPY ABSTRACT CLINICAL TRIAL, PHASE I CLINICAL TRIAL, PHASE II
931230
M93C0823

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