Sarcoma Clinical Trial
Official title:
Pilot Study Of Valganciclovir In Patients With Classic, Non-HIV-Associated Kaposi's Sarcoma
RATIONALE: Herpesvirus is found in the lesions of most patients with Kaposi's sarcoma, and
may have a role in causing Kaposi's sarcoma. Valganciclovir is an antiviral drug that acts
against many types of herpesviruses and may be an effective treatment for Kaposi's sarcoma.
PURPOSE: This clinical trial is studying how well valganciclovir works in treating patients
with classic non-HIV-associated Kaposi's sarcoma.
OBJECTIVES:
Primary
- Determine the antitumor activity of valganciclovir in patients with classic
non-HIV-associated Kaposi's sarcoma (KS).
Secondary
- Determine the effect of this drug on lytic and latent human herpesvirus-8 gene
expression in KS lesions of these patients.
- Determine the effect of this drug on the markers of angiogenesis in KS lesions of these
patients.
- Determine the safety and tolerability of this drug in these patients.
OUTLINE: This is a pilot study.
Patients receive oral valganciclovir twice daily for 3 weeks and then once daily for 21
weeks in the absence of disease progression or unacceptable toxicity.
All patients are followed for 1 month after completion of therapy. Patients with responding
disease are followed monthly for up to 1 year.
PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study within 1 year.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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