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

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: National Cancer Institute (NCI); New York Presbyterian Hospital; University of North Carolina, Chapel Hill; Weill Medical College of Cornell University
• Treatments: Ganciclovir; Valganciclovir

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