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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Memorial Sloan - Kettering Cancer Center
New York, New York, United States
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
Tumor Response Rate Every 4 Weeks
Time frame: 2 years
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