Document 1089
 DOCN  M9471089
 TI    A trial of Paclitaxel (TAXOL) in patients with HIV-associated Kaposi's
       sarcoma (KS) (Meeting abstract).
 DT    9409
 AU    Saville MW; Lietzau J; Wilson W; Pluda J; Bailey J; Cohen R; Feigal E;
       Broder S; Yarchoan R; NCI, Bethesda, MD 20892
 SO    Proc Annu Meet Am Soc Clin Oncol; 13:A20 1994. Unique Identifier :
       AIDSLINE ICDB/94600017
 AB    KS is a frequent cause of severe morbidity and death in patients with
       human immunodeficiency virus (HIV) infection. Current therapies are
       often poorly tolerated, and new drugs are needed for this condition. It
       has been observed that inhibitors of microtubule assembly are active
       against KS, and this led us to consider paclitaxel, an agent that causes
       microtubule polymerization, as a potential therapy for this disorder. In
       in vitro studies, we found that paclitaxel inhibited the proliferation
       of a KS-derived spindle cell line at a concentration of approximately 10
       nM. As a prelude to conducting a formal Phase II study, we treated three
       KS pts with 105 mg/m2 paclitaxel by continuous 96 hr infusion every 21
       days. Toxicity consisted of moderate myelosuppression, alopecia, one
       acute skin rash, and four episodes of central venous catheter infection.
       Each of two evaluable pts, including one with pulmonary involvement,
       achieved a partial response (PR). We subsequently initiated a Phase II
       trial of paclitaxel 135 mg/m2, administered as a 3 hour infusion by
       peripheral catheter, with dose escalation each cycle as tolerated to a
       maximum of 155 mg/m2. The 3 hour infusion schedule was chosen as being
       more practical than a 96-hr infusion, and to avoid the problem of line
       infections associated with an indwelling catheter. Patients entered on
       this study could have had a maximum of one prior course of cytotoxic
       chemotherapy, and could have visceral disease which was not immediately
       life-threatening. Six patients have been entered to date. Despite
       limited follow up (average 2.6 cycles of treatment), one patient has
       attained a PR and none have had progression. Two patients developed a
       skin rash 10 days after treatment, and one developed fever, malaise, and
       thrombocytopenia 18-24 days after treatment for two consecutive cycles.
       Otherwise, myelosuppression has been brief and not associated with
       infection. Updated results will be presented.
 DE    Cell Division/DRUG EFFECTS  Dose-Response Relationship, Drug  Follow-Up
       Studies  HIV Infections/*DRUG THERAPY/PATHOLOGY  Human  Infusions,
       Intravenous  Sarcoma, Kaposi's/*DRUG THERAPY/PATHOLOGY  Skin
       Neoplasms/*DRUG THERAPY/PATHOLOGY  Taxol/*ADMINISTRATION &
       DOSAGE/ADVERSE EFFECTS  MEETING ABSTRACT  CLINICAL TRIAL  CLINICAL
       TRIAL, PHASE II

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