Liposomal Daunorubicin in Treating Patients With HIV-Related Kaposi's Sarcoma
| Status: | Archived |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
Pilot Study of Viral Load and Transcription in Kaposi's Sarcoma Patients Treated With Liposomal Anthracyclines
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.
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.
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