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Valganciclovir in Treating Patients With Classic Non-HIV-Associated Kaposi's Sarcoma
This study has been completed.
Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborators:
National Cancer Institute (NCI)
New York Presbyterian Hospital
Weill Medical College of Cornell University
University of North Carolina, Chapel Hill
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00096538
First received: November 9, 2004
Last updated: October 21, 2015
Last verified: October 2015
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Purpose
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 |
|---|---|
| Sarcoma | Drug: valganciclovir |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Pilot Study Of Valganciclovir In Patients With Classic, Non-HIV-Associated Kaposi's Sarcoma |
Resource links provided by NLM:
Further study details as provided by Memorial Sloan Kettering Cancer Center:
Primary Outcome Measures:
- Tumor Response Rate Every 4 Weeks [ Time Frame: 2 years ]
| Enrollment: | 6 |
| Study Start Date: | April 2004 |
| Study Completion Date: | February 2008 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: valganciclovir
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.
|
Drug: valganciclovir |
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 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.
Eligibility| Ages Eligible for Study: | 18 Years to 120 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00096538
Please refer to this study by its ClinicalTrials.gov identifier: NCT00096538
Locations
| 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 | |
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
New York Presbyterian Hospital
Weill Medical College of Cornell University
University of North Carolina, Chapel Hill
Investigators
| Study Chair: | Susan E. Krown, MD | Memorial Sloan Kettering Cancer Center |
More Information
| Responsible Party: | Memorial Sloan Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00096538 History of Changes |
| Other Study ID Numbers: |
04-055 MSKCC-04055 |
| Study First Received: | November 9, 2004 |
| Results First Received: | October 21, 2015 |
| Last Updated: | October 21, 2015 |
Keywords provided by Memorial Sloan Kettering Cancer Center:
|
classic Kaposi sarcoma recurrent Kaposi sarcoma |
Additional relevant MeSH terms:
|
Sarcoma Sarcoma, Kaposi Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Herpesviridae Infections DNA Virus Infections |
Virus Diseases Neoplasms, Vascular Tissue Valganciclovir Ganciclovir Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on July 17, 2017