Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00096538
Status:
COMPLETED
Last Update Posted:
2015-11-25
First Post:
2004-11-09
Brief Title:
Valganciclovir in Treating Patients With Classic Non-HIV-Associated Kaposis Sarcoma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Pilot Study Of Valganciclovir In Patients With Classic Non-HIV-Associated Kaposis Sarcoma
Status:
COMPLETED
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Herpesvirus is found in the lesions of most patients with Kaposis sarcoma and may have a role in causing Kaposis sarcoma Valganciclovir is an antiviral drug that acts against many types of herpesviruses and may be an effective treatment for Kaposis sarcoma
PURPOSE This clinical trial is studying how well valganciclovir works in treating patients with classic non-HIV-associated Kaposis sarcoma
PURPOSE This clinical trial is studying how well valganciclovir works in treating patients with classic non-HIV-associated Kaposis sarcoma
Detailed Description:
OBJECTIVES
Primary
Determine the antitumor activity of valganciclovir in patients with classic non-HIV-associated Kaposis 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
Primary
Determine the antitumor activity of valganciclovir in patients with classic non-HIV-associated Kaposis 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MSKCC-04055 | None | None | None |