Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Treatment	Completed	18 and over	NCI	MSKCC-04055 NCT00096538

Objectives

Primary

1. Determine the antitumor activity of valganciclovir in patients with classic non-HIV-associated Kaposi's sarcoma (KS).

Secondary

1. Determine the effect of this drug on lytic and latent human herpesvirus-8 gene expression in KS lesions of these patients.
2. Determine the effect of this drug on the markers of angiogenesis in KS lesions of these patients.
3. Determine the safety and tolerability of this drug in these patients.

Entry 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

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

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/mm³
• Platelet count ≥ 100,000/mm³

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

Expected Enrollment

A total of 15 patients will be accrued for this study within 1 year.

Outcomes

Tumor response rate every 4 weeks

Human herpesvirus-8 gene expression in tumor biopsies by quantitative real-time polymerase chain reaction at baseline, week 4, and week 16
Markers of angiogenesis in tumor biopsies by immunohistochemistry at baseline, week 4, and week 16

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.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Susan Krown, MD, Protocol chair		Ph: 212-639-7426; 800-525-2225 Email: krowns@mskcc.org

Registry Information
Official Title		Pilot Study Of Valganciclovir In Patients With Classic, Non-HIV-Associated Kaposi's Sarcoma
Trial Start Date		2004-04-27
Trial Completion Date		2008-02-26
Registered in ClinicalTrials.gov		NCT00096538
Date Submitted to PDQ		2004-09-16
Information Last Verified		2008-03-30
NCI Grant/Contract Number		CA08748

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