Phase II trial of 13-cis-retinoic acid (CRA) in AIDS-related Kaposi's sarcoma (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 II trial of 13-cis-retinoic acid (CRA) in AIDS-related Kaposi's sarcoma (KS) (Meeting abstract).

Proc Annu Meet Am Assoc Cancer Res; 14:A835 1995. Unique Identifier : AIDSLINE ICDB/95613987
Lewi D; Reboredo G; Jauregui Rueda H; Monticelli A; Losso M; Vujacich C; Litovska S; Marantz A; De la Torre A; Politi P; Hospitals de Clinicas, Muniz, Argentina

Abstract: Between February and November 1994, 14 ambulatory (PS 0-2) male patients (pts) with measurable KS and good bone marrow, hepatic and renal function were treated continuously with CRA (isotretinoin, Roaccutane, Hoffmann-LaRoche) at a dose of 1 mg/kg/day, po, on an outpatient basis. Standard response (ECOG) and toxicity (NCI) criteria were used. Pts gave written informed consent. The protocol received IRB approval. Mean age was 39 (29-72), mean baseline CD4, 149/ul (10-310), p24 antigen was positive in 1/12 pts tested. 12 pts had mucocutaneous KS, and 12 pts had a history of opportunistic infections. All 14 pts received AZT (6/14 were on AZT+DDC). All pts were evaluable. 1/14 pts responded, (7%; CI 0-21%) for 3 months. Bleaching and flattening of lesions was observed in 5 and 2 pts, respectively. CD4 counts at 2 months decreased in 5 pts, and 12/12 follow-up p24 tests were negative. Median time to progression was 3 months. Toxicity required drug discontinuation in 4 pts, due to G3 stomatitis (1 pt), G2 headache (2 pts), G2 liver toxicity (1 pt). Dry mouth and skin were reported in all pts. CRA in this dose and schedule shows minimal activity in KS.

Keywords: Acquired Immunodeficiency Syndrome/*COMPLICATIONS/DRUG THERAPY/ IMMUNOLOGY Adult Aged Antineoplastic Agents/*TOXICITY/*THERAPEUTIC USE AIDS-Related Opportunistic Infections/EPIDEMIOLOGY CD4 Lymphocyte Count Drug Therapy, Combination Human Isotretinoin/*TOXICITY/*THERAPEUTIC USE Male Middle Age Sarcoma, Kaposi's/*DRUG THERAPY/*ETIOLOGY/IMMUNOLOGY Zalcitabine/THERAPEUTIC USE Zidovudine/THERAPEUTIC USE ABSTRACT CLINICAL TRIAL CLINICAL TRIAL, PHASE II
951230
M95C3219

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