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

Not Applicable

Completed

• Conditions: Sarcoma
• Interventions: Drug: valganciclovir

• Registration Number: NCT00096538
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief 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.

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2004-11-09
• Study First Submitted QC: 2004-11-09
• Study First Posted: 2004-11-10
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Status Verified: 2015-10
• Results First Submitted: 2015-10-21
• Results First Submitted QC: 2015-10-21
• Last Update Submitted: 2015-10-21
• Results First Posted: 2015-11-25
• Last Update Posted: 2015-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
valganciclovir	valganciclovir	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.

Primary Outcome Measures

Name	Time	Method
Tumor Response Rate Every 4 Weeks	2 years

Trial Locations

Locations (3)

Memorial Sloan - Kettering Cancer Center; 🇺🇸 New York, New York, United States

New York Weill Cornell Cancer Center at Cornell University; 🇺🇸 New York, New York, United States

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States