valganciclovir in treating patients with classic non-hiv-associated kaposi's sarcoma

Conditions: Sarcoma

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.

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.

Eligibility criteria:
disease characteristics: * histologically confirmed classic kaposi's sarcoma (ks) involving the skin * non-hiv-associated disease * hiv negative * measurable disease * at least 8 ks lesions with ≥ 5 marker lesions measurable in 2 dimensions and ≥ 3 other lesions measuring ≥ 1 cm in diameter * two 3 mm punch biopsies of a non-marker lesion entirely composed of ks * irradiated cutaneous lesions may not be used as indicator lesions * no known active visceral ks or symptomatic ks-related edema that would preclude function or require cytotoxic chemotherapy patient characteristics: age * 18 and over performance status * karnofsky 70-100% life expectancy * at least 12 months hematopoietic * hemoglobin ≥ 8 g/dl * absolute neutrophil count ≥ 1,500/mm\^3 * platelet count ≥ 100,000/mm\^3 hepatic * bilirubin ≤ 1.5 times upper limit of normal (uln) * ast and alt ≤ 3 times uln renal * creatinine clearance ≥ 50 ml/min other * not pregnant or nursing * negative pregnancy test * fertile patients must use effective barrier contraception during and for 3 months after study participation * no hypersensitivity to valganciclovir or ganciclovir * no other neoplasia requiring cytotoxic therapy prior concurrent therapy: biologic therapy * more than 4 weeks since prior biological therapy for ks * no concurrent immunotherapy chemotherapy * more than 4 weeks since prior chemotherapy for ks * no concurrent chemotherapy endocrine therapy * no concurrent corticosteroid treatment except for replacement doses (equivalent to 20 mg of hydrocortisone per day) radiotherapy * see disease characteristics * more than 4 weeks since prior radiotherapy for ks * no concurrent radiotherapy surgery * not specified other * more than 14 days since prior acute treatment for infection (other than oral thrush or genital herpes) or other serious medical illness * more than 60 days since prior local therapy for any ks indicator lesion unless the lesion showed documented progression since treatment * more than 4 weeks since prior local therapy for ks * more than 4 weeks since prior investigational agents * more than 4 weeks since other prior antineoplastic therapy for ks * no other concurrent antiviral therapy * no other concurrent investigational agents * no other concurrent systemic therapy for ks

Keywords: classic kaposi sarcoma recurrent kaposi sarcoma