Conditions: Sarcoma
Keywords: classic Kaposi sarcoma recurrent Kaposi sarcoma
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 6
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: 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.

Interventions: intervention 1: valganciclovir
Intervention descriptions: intervention 1: None

Protocol document: