Ignite Creation Date:
2025-12-18 @ 9:50 AM
Ignite Modification Date:
2025-12-23 @ 10:01 PM
Study NCT ID:
NCT00427414
Status:
None
Last Update Posted:
2015-04-29 00:00:00
First Post:
2007-01-25 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Liposomal Daunorubicin in Treating Patients With HIV-Related Kaposi's Sarcoma
Sponsor:
None
Organization:
Study Overview
Official Title:
Pilot Study of Viral Load and Transcription in Kaposi's Sarcoma Patients Treated With Liposomal Anthracyclines
Status:
None
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated due to slow accrual.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
OBJECTIVES:
Primary
* Determine the effect of liposomal daunorubicin citrate on Kaposi's sarcoma-associated herpes virus (KSHV) viral gene expression in tumors of patients with HIV-related Kaposi's sarcoma.
Secondary
* Determine the effect of this drug on KSHV viral gene expression in peripheral blood mononuclear cells.
* Determine the effect of this drug on KSHV viral load in plasma.
* Correlate viral load with viral gene expression and/or tumor regression in these patients.
OUTLINE: This is a multicenter, pilot study.
Patients receive liposomal daunorubicin citrate IV days 1 and 15. Treatment repeats every 4 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity.
Biopsies are performed at baseline and once during treatment to evaluate Kaposi's sarcoma- associated herpes virus (KSHV) viral gene expression in tumors and skin tissue using reverse transcriptase-quantitative polymerase chain reaction. Blood samples are collected at baseline and periodically during treatment to evaluate KSHV viral gene expression in peripheral blood mononuclear cells and viral load in plasma.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Primary
* Determine the effect of liposomal daunorubicin citrate on Kaposi's sarcoma-associated herpes virus (KSHV) viral gene expression in tumors of patients with HIV-related Kaposi's sarcoma.
Secondary
* Determine the effect of this drug on KSHV viral gene expression in peripheral blood mononuclear cells.
* Determine the effect of this drug on KSHV viral load in plasma.
* Correlate viral load with viral gene expression and/or tumor regression in these patients.
OUTLINE: This is a multicenter, pilot study.
Patients receive liposomal daunorubicin citrate IV days 1 and 15. Treatment repeats every 4 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity.
Biopsies are performed at baseline and once during treatment to evaluate Kaposi's sarcoma- associated herpes virus (KSHV) viral gene expression in tumors and skin tissue using reverse transcriptase-quantitative polymerase chain reaction. Blood samples are collected at baseline and periodically during treatment to evaluate KSHV viral gene expression in peripheral blood mononuclear cells and viral load in plasma.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Detailed Description:
None
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?: