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

NCT ID: NCT00096538

Last Updated: 2015-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-04-30
• Study Completion Date: 2008-02-29

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.

Conditions

Sarcoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

valganciclovir

Intervention Type: DRUG

Interventions

valganciclovir

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

New York Presbyterian Hospital

OTHER

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan E. Krown, MD

Role: STUDY_CHAIR

Memorial Sloan Kettering Cancer Center

Locations

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

Countries

United States

Other Identifiers

MSKCC-04055

Identifier Type: -

Identifier Source: secondary_id

04-055

Identifier Type: -

Identifier Source: org_study_id