Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00019240
Status:
COMPLETED
Last Update Posted:
2013-06-20
First Post:
2001-07-11
Brief Title:
Antiviral Therapy in Treating Patients With Kaposis Sarcoma With or Without HIV Infection
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
PHASE II PROTOCOL WITH LABORATORY CORRELATES OF 1-S-3-HYDROXY-2-PHOSPHOMETHOXYPROPYLCYTOSINE DIHYDRATECIDOFOVIR IN PATIENTS WITH KAPOSIS SARCOMA KS
Status:
COMPLETED
Status Verified Date:
2007-11
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 Kaposis sarcoma lesions in most patients it is therefore possible that the herpesvirus has a role in causing Kaposis sarcoma Cidofovir is an antiviral drug that acts against many types of herpesvirus and may be an effective treatment for Kaposis sarcoma
PURPOSE Phase II trial to study the effectiveness of cidofovir in treating patients with Kaposis sarcoma with or without HIV infection
PURPOSE Phase II trial to study the effectiveness of cidofovir in treating patients with Kaposis sarcoma with or without HIV infection
Detailed Description:
OBJECTIVES I Assess the antitumor activity of intravenous cidofovir in patients with Kaposis sarcoma KS with and without human immunodeficiency virus HIV infection II Assess the effect of intravenous cidofovir on the load of KS-associated herpesvirushuman herpesvirus-8 in KS lesions and peripheral blood mononuclear cells by quantitative polymerase chain reaction III Assess the toxicity of cidofovir in KS patients with and without HIV infection IV Assess the effect of cidofovir on angiogenic cytokines related to the pathogenesis of KS
OUTLINE All patients receive intravenous cidofovir weekly for 2 weeks then every other week for 6 months Patients with a complete or partial response may continue treatment until disease progression intervenes
PROJECTED ACCRUAL Up to 25 evaluable patients will be entered over approximately 6 months if there are at least 2 responses in the first 15 patients
OUTLINE All patients receive intravenous cidofovir weekly for 2 weeks then every other week for 6 months Patients with a complete or partial response may continue treatment until disease progression intervenes
PROJECTED ACCRUAL Up to 25 evaluable patients will be entered over approximately 6 months if there are at least 2 responses in the first 15 patients
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 |
|---|---|---|---|
| NCI-97-C-0024C | None | None | None |