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

Sarcoma Clinical Trial

Official title:

Pilot Study Of Valganciclovir In Patients With Classic, Non-HIV-Associated Kaposi's Sarcoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00096538
• Other study ID #: 04-055
• Secondary ID: MSKCC-04055
• Status: Completed
• Phase: N/A
• First received: November 9, 2004
• Last updated: October 21, 2015
• Start date: April 2004
• Est. completion date: February 2008

Study information

• Verified date: October 2015
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 120 Years

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sarcoma
• Sarcoma, Kaposi

Intervention

Drug:
• valganciclovir

Locations

Country	Name	City	State
United States	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill	Chapel Hill	North Carolina
United States	Memorial Sloan - Kettering Cancer Center	New York	New York
United States	New York Weill Cornell Cancer Center at Cornell University	New York	New York

Sponsors (5)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI), New York Presbyterian Hospital, University of North Carolina, Chapel Hill, Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor Response Rate Every 4 Weeks		2 years	No