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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pilot Study Of Valganciclovir In Patients With Classic, Non-HIV-Associated Kaposi's Sarcoma

Conditions
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Sarcoma

Intervention / Treatment
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* Drug: valganciclovir


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: valganciclovir<br>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. | Drug: valganciclovir<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor Response Rate Every 4 Weeks |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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classic Kaposi sarcoma, recurrent Kaposi sarcoma