Important note: Information in this article was accurate in 1993. The state of the art may have changed since the publication date.
All-trans-retinoic acid (TRA) in the treatment of AIDS-related kaposi's sarcoma (Kaposi's sarcoma: a Phase II Illinois Cancer Center Study) (Meeting abstract).
Proc Annu Meet Am Soc Clin Oncol; 12:A6 1993. Unique Identifier : AIDSLINE ICDB/93694406 Von Roenn J; von Gunten C; Mullane M; French S; Blough R; Benson AB; Illinois Cancer Center, Chicago, IL 60604
Abstract:
TRA is a major endogenous metabolite of vitamin A which induces differentiation and/or growth inhibition in many tumorigenic cell lines. TRA is associated with suppression of both the IL-6 receptor alpha chain and IL-6 secretion and inhibits AIDS KS cells from proliferating in culture. 14 patients (pts) with AIDS-related KS were entered on this Phase II trial. Eligibility: 10 or more mucocutaneous lesions, 10 or more new lesions in the month preceding study entry, visceral involvement or oral or mucosal lesions requiring therapy, HIV antibody positive, no more than one prior chemotherapy regimen, ECOG performance status 0, 1 or 2 and no active uncontrolled infections. ACTG defined response criteria for KS were utilized. The first 6 pts were treated with TRA 175 mg/m2 po, daily. Five of the 6 pts enrolled at the 175 mg/m2 dose developed rapidly progressive disease with a mean duration of therapy of 31.6 days. One pt was taken off study due to recurrent hypercalcemia and pancreatitis. The remaining pts were treated with TRA 100 mg/m2 po qd. Two pts remain on study, 1 with stable disease for 3 mo and 1 too early to evaluate for response. The median age is 36 yr (27-54), the median performance status is 0 (0-1). One additional pt had stable disease over a 5-mo period, and elected to discontinue treatment because of generalized malaise. The remaining pts were removed from study for drug-related toxicity: 2 for severe nausea and vomiting, 2 pts for intolerable headaches and 1 pt for severe rash. In summary, 5/6 pts developed rapidly progressive disease with TRA 175 mg/m2/day; 2/8 pts treated with TRA 100 mg/m2/day have stable disease. The progressive disease seen at the high dose of therapy raises the question as to the differential effect of TRA on cytokines at different dose levels of TRA. Retinoic acid has been shown in vitro to inhibit HIV replication. Because of this and the relative lack of marrow or hepatic toxicity and the observation of stable disease in some pts at the lower dose, we feel this compound deserves further evaluation at various dose levels in pts with AIDS-related KS.
Keywords: Acquired Immunodeficiency Syndrome/*DRUG THERAPY Adult Dose-Response Relationship, Drug Drug Administration Schedule Female Follow-Up Studies Gastrointestinal Neoplasms/*DRUG THERAPY Human Male Middle Age Mouth Neoplasms/*DRUG THERAPY Sarcoma, Kaposi's/*DRUG THERAPY Tretinoin/*ADMINISTRATION & DOSAGE/ADVERSE EFFECTS ABSTRACT CLINICAL TRIAL, PHASE II 931230
M93C0821
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Important note: Information in this article was accurate in 1993. The state of the art may have changed since the publication date.
