Patient case: 78-year-old female with sarcoma; genetic feature: MDM2

Clinical trial: Valganciclovir in Treating Patients With Classic Non-HIV-Associated Kaposi's 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.

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.

Eligibility: 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

Relevance to patient case: not relevant