Clinical trial · Interventional
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
NCT00096538CI-TRIAL-00019945completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| valganciclovir | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- valganciclovir
- description
- 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.
- interventionNames
- Drug: valganciclovir
Primary outcomes (1)
- measure
- Tumor Response Rate Every 4 Weeks
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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 KSReferences
Publications (0)
Data not yet available
No reference posted for this study.