NCT00427414

Liposomal Daunorubicin in Treating Patients With HIV-Related Kaposi's Sarcoma

Pilot Study of Viral Load and Transcription in Kaposi's Sarcoma Patients Treated With Liposomal Anthracyclines

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: AIDS Malignancy Consortium · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as liposomal daunorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This clinical trial is studying how well liposomal daunorubicin works in treating patients with HIV-related Kaposi's sarcoma.

Detailed description

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.

Conditions

• Sarcoma

Interventions

Type	Name	Description
DRUG	liposomal daunorubicin citrate	40 mg/m2 Days 1 and 15 every 28 days x 3 cycles

Timeline

• Start date: 2008-09-01
• Primary completion: 2010-11-01
• Completion: 2011-11-01
• First posted: 2007-01-29
• Last updated: 2015-04-29

Locations

3 sites across 2 countries: United States, Brazil