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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Sarcoma

Intervention / Treatment
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* Drug: liposomal daunorubicin citrate


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed Kaposi's sarcoma (KS) involving the following: Skin Lymph nodes (palpable disease only) Oral cavity Must have ≥ 5 measurable, previously nonirradiated, cutaneous lesions that can be used as indicator lesions Must have 2 lesions ≥ 5 x 5 mm that are accessible for 4 mm punch biopsy Serologically confirmed HIV positivity Concurrent antiretroviral therapy required, except for patients who have exhausted all available treatment options Must be on a stable dose for ≥ 4 weeks PATIENT CHARACTERISTICS: Life expectancy ≥ 3 months No other neoplasia requiring cytotoxic therapy Not pregnant or nursing Fertile patients must use effective barrier contraception during and for 3 months after completion of study treatment PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior anthracycline therapy At least 4 weeks since prior antineoplastic treatment for KS, including any of the following: Chemotherapy (6 weeks for nitrosoureas or mitomycin C) Radiotherapy Local therapy Biological therapy Investigational therapy At least 60 days since prior local therapy of any KS indicator lesion unless lesion has clearly progressed since treatment No other concurrent investigational drugs, cytotoxic chemotherapy, or KS-specific treatment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: liposomal daunorubicin citrate<br>40 mg/m2 Days 1 and 15 every 28 days x 3 cycles | Drug: liposomal daunorubicin citrate<br>* 40 mg/m2 Days 1 and 15 every 28 days x 3 cycles<br>* Other names: DaunoXome;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of liposomal daunorubicin citrate on Kaposi's sarcoma-associated herpes virus (KSHV) viral gene expression in tumors |  | 24-48 hours after the first treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of treatment on KSHV viral gene expression in peripheral blood mononuclear cells |  | 24-48 hours after treatment on Day 1/cycle 1, Day 8/cycle 1, and Day 29/cycle 3 | 
| Effect of treatment on KSHV viral load in plasma |  | 24-48 hours after treatment on Day 1/cycle 1, Day 8/cycle 1, and Day 29/cycle 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AIDS-related Kaposi sarcoma, recurrent Kaposi sarcoma