Pilot Study Of Valganciclovir In Patients With Classic, Non-HIV-Associated Kaposi's Sarcoma
- Determine the antitumor activity of valganciclovir in patients with classic
non-HIV-associated Kaposi's sarcoma (KS).
- 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
- 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
Tumor response rate every 4 weeks
Susan E. Krown, MD
Memorial Sloan-Kettering Cancer Center
United States: Institutional Review Board
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill||Chapel Hill, North Carolina 27599-7570|
|New York Weill Cornell Cancer Center at Cornell University||New York, New York 10021|
|Memorial Sloan - Kettering Cancer Center||New York, New York 10021|