N/A
N=6
Valganciclovir in Treating Patients With Classic Non-HIV-Associated Kaposi's Sarcoma
Sarcoma
Bottom Line
View on ClinicalTrials.gov: NCT00096538 ↗Enrolled (actual)
6
Serious AEs
16.7%
Results posted
Nov 2015
Primary outcome: Primary: Tumor Response Rate Every 4 Weeks — 4; 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- valganciclovir (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Primary completion
- Feb 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tumor Response Rate Every 4 Weeks |
4; 1 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00096538). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.