Valganciclovir in Treating Patients With Classic Non-HIV-Associated Kaposi's Sarcoma

Inclusion 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