A randomized dose finding study of recombinant platelet factor 4 (rPF4) in cutaneous AIDS-related Kaposi's sarcoma (KS) (Meeting abstract). NLM AIDSLINE Important note: Information in this article was accurate in 1994. The state of the art may have changed since the publication date.

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A randomized dose finding study of recombinant platelet factor 4 (rPF4) in cutaneous AIDS-related Kaposi's sarcoma (KS) (Meeting abstract).

Proc Annu Meet Am Soc Clin Oncol; 13:A3 1994. Unique Identifier : AIDSLINE ICDB/94699999
Staddon A; Henry D; Bonnem E; Graduate Hosp., Philadelphia, PA 19146

Abstract: rPF4 is an angiogenesis inhibitor currently being tested in cancer. A prior study (ASCO 1993) established an acceptable safety profile and provided preliminary evidence of biologic activity with 4 wk of treatment. To further assess the activity of rPF4, we initiated a dose finding study of rPF4 administered via intralesional dosing (IL) for longer periods of time. Patients were to be randomized to 2.5 mg or 5.0 mg IL three times per week. To date, 9 males, median age 35 (28-57) have been enrolled. Seven are available for response. Comparisons were made among 3 sets of lesions: injected, proximal non-injected, and distant non-injected. Tumor response rates were 57%, 17%, and 0% respectively. Data are shown in a table. Pain at the injection site occurred in nearly all patients; it was usually considered mild to moderate; one patient discontinued due to pain at the injection site. No other toxicity was noted. This study suggests rPF4 to be an active drug in treatment of KS. However, intralesional dosing appears suboptimal to achieve systemic levels. Additional systemic trials are planned.
Keywords: Adult Comparative Study Dose-Response Relationship, Drug Drug Administration Schedule Human HIV Infections/*THERAPY Injections, Intralesional Male Platelet Factor 4/*ADMINISTRATION & DOSAGE Recombinant Proteins/ADMINISTRATION & DOSAGE Sarcoma, Kaposi's/*THERAPY Skin Neoplasms/*THERAPY ABSTRACT CLINICAL TRIAL RANDOMIZED CONTROLLED TRIALKWDadultcomparativestudydose-responserelationship,drugdrugadministrationschedulehumanhivinfections/KWDtherapyinjections,intralesionalmaleplateletfactor4/KWDadministration&dosagerecombinantproteins/administration&dosagesarcoma,kaposi's/KWDtherapyskinneoplasms/KWDtherapyabstractclinicaltrialrandomizedcontrolledtrial
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M9480777

Copyright © 1994 - National Library of Medicine. Reproduced under license with the National Library of Medicine, Bethesda, MD.

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