Status:
COMPLETED
Valganciclovir in Treating Patients With Classic Non-HIV-Associated Kaposi's Sarcoma
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
New York Presbyterian Hospital
Conditions:
Sarcoma
Eligibility:
All Genders
18-120 years
Phase:
NA
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...
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 a...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00096538
Start Date
April 1 2004
End Date
February 1 2008
Last Update
November 25 2015
Active Locations (3)
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1
Memorial Sloan - Kettering Cancer Center
New York, New York, United States, 10021
2
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States, 10021
3
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295