Valganciclovir in Treating Patients With Classic Non-HIV-Associated Kaposi's Sarcoma
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|ClinicalTrials.gov Identifier: NCT00096538|
Recruitment Status : Completed
First Posted : November 10, 2004
Results First Posted : November 25, 2015
Last Update Posted : November 25, 2015
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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.
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma||Drug: valganciclovir||Not Applicable|
- Determine the antitumor activity of valganciclovir in patients with classic non-HIV-associated Kaposi's sarcoma (KS).
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study Of Valganciclovir In Patients With Classic, Non-HIV-Associated Kaposi's Sarcoma|
|Study Start Date :||April 2004|
|Actual Primary Completion Date :||February 2008|
|Actual Study Completion Date :||February 2008|
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.
- Tumor Response Rate Every 4 Weeks [ Time Frame: 2 years ]
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|Ages Eligible for Study:||18 Years to 120 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Histologically confirmed classic Kaposi's sarcoma (KS) involving the skin
- HIV negative
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
- 18 and over
- Karnofsky 70-100%
- At least 12 months
- Hemoglobin ≥ 8 g/dL
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST and ALT ≤ 3 times ULN
- Creatinine clearance ≥ 50 mL/min
- 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:
- More than 4 weeks since prior biological therapy for KS
- No concurrent immunotherapy
- More than 4 weeks since prior chemotherapy for KS
- No concurrent chemotherapy
- No concurrent corticosteroid treatment except for replacement doses (equivalent to 20 mg of hydrocortisone per day)
- See Disease Characteristics
- More than 4 weeks since prior radiotherapy for KS
- No concurrent radiotherapy
- Not specified
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00096538
|United States, New York|
|Memorial Sloan - Kettering Cancer Center|
|New York, New York, United States, 10021|
|New York Weill Cornell Cancer Center at Cornell University|
|New York, New York, United States, 10021|
|United States, North Carolina|
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599-7295|
|Study Chair:||Susan E. Krown, MD||Memorial Sloan Kettering Cancer Center|
|Responsible Party:||Memorial Sloan Kettering Cancer Center|
|Other Study ID Numbers:||
|First Posted:||November 10, 2004 Key Record Dates|
|Results First Posted:||November 25, 2015|
|Last Update Posted:||November 25, 2015|
|Last Verified:||October 2015|
classic Kaposi sarcoma
recurrent Kaposi sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
DNA Virus Infections
Neoplasms, Vascular Tissue