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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00096538 |
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 | Intervention |
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Sarcoma |
Drug: valganciclovir |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Pilot Study Of Valganciclovir In Patients With Classic, Non-HIV-Associated Kaposi's Sarcoma |
Estimated Enrollment: | 15 |
Study Start Date: | April 2004 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed classic Kaposi's sarcoma (KS) involving the skin
Non-HIV-associated disease
Measurable disease
At least 8 KS lesions with ≥ 5 marker lesions measurable in 2 dimensions AND ≥ 3 other lesions measuring ≥ 1 cm in diameter
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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 |
Study ID Numbers: | CDR0000393194, MSKCC-04055 |
Study First Received: | November 9, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00096538 |
Health Authority: | United States: Federal Government |
classic Kaposi sarcoma recurrent Kaposi sarcoma |
Virus Diseases Neoplasms, Connective and Soft Tissue Kaposi sarcoma Valganciclovir Malignant mesenchymal tumor Sarcoma, Kaposi |
Sarcoma Ganciclovir DNA Virus Infections Soft tissue sarcomas Recurrence Herpesviridae Infections |
Anti-Infective Agents Neoplasms Neoplasms by Histologic Type Therapeutic Uses |
Neoplasms, Vascular Tissue Antiviral Agents Pharmacologic Actions |