Sarcoma Clinical Trial
Official title:
PHASE II PROTOCOL WITH LABORATORY CORRELATES OF 1-[(S)-3-HYDROXY-2-(PHOSPHOMETHOXY)PROPYL]CYTOSINE DIHYDRATE(CIDOFOVIR) IN PATIENTS WITH KAPOSI'S SARCOMA (KS)
RATIONALE: Herpesvirus is found in Kaposi's sarcoma lesions in most patients; it is
therefore possible that the herpesvirus has a role in causing Kaposi's sarcoma. Cidofovir is
an antiviral drug that acts against many types of herpesvirus, and may be an effective
treatment for Kaposi's sarcoma.
PURPOSE: Phase II trial to study the effectiveness of cidofovir in treating patients with
Kaposi's sarcoma with or without HIV infection.
OBJECTIVES: I. Assess the antitumor activity of intravenous cidofovir in patients with
Kaposi's sarcoma (KS) with and without human immunodeficiency virus (HIV) infection. II.
Assess the effect of intravenous cidofovir on the load of KS-associated herpesvirus/human
herpesvirus-8 in KS lesions and peripheral blood mononuclear cells by quantitative
polymerase chain reaction. III. Assess the toxicity of cidofovir in KS patients with and
without HIV infection. IV. Assess the effect of cidofovir on angiogenic cytokines related to
the pathogenesis of KS.
OUTLINE: All patients receive intravenous cidofovir weekly for 2 weeks, then every other
week for 6 months. Patients with a complete or partial response may continue treatment until
disease progression intervenes.
PROJECTED ACCRUAL: Up to 25 evaluable patients will be entered over approximately 6 months
if there are at least 2 responses in the first 15 patients.
;
Primary Purpose: Treatment
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