Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00096538
Enrollment
6
Registered
2004-11-10
Start date
2004-04-30
Completion date
2008-02-29
Last updated
2015-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcoma

Keywords

classic Kaposi sarcoma, recurrent Kaposi sarcoma

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.

Interventions

DRUGvalganciclovir

Sponsors

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

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Tumor Response Rate Every 4 Weeks2 years

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
6
Total6

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyWithdrawal by Subject1

Baseline characteristics

CharacteristicValganciclovir
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
5 Participants
Age, Categorical
Between 18 and 65 years
1 Participants
Region of Enrollment
United States
6 participants
Sex: Female, Male
Female
0 Participants
Sex: Female, Male
Male
6 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
2 / 6
serious
Total, serious adverse events
1 / 6

Outcome results

Primary

Tumor Response Rate Every 4 Weeks

Time frame: 2 years

ArmMeasureGroupValue (NUMBER)
ValganciclovirTumor Response Rate Every 4 WeeksProgression of Disease4 participants
ValganciclovirTumor Response Rate Every 4 WeeksStable Disease1 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026