Valganciclovir in Treating Patients With Classic Non-HIV-Associated Kaposi's Sarcoma (NCT00096538) | Clinical Trial Compass
CompletedNot Applicable
Valganciclovir in Treating Patients With Classic Non-HIV-Associated Kaposi's Sarcoma
United States6 participantsStarted 2004-04
Plain-language 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.
Who can participate
Age range18 Years – 120 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 corticoster…