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

Phase 1TerminatedNCT00427414

AIDS Malignancy Consortium14 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Sarcoma

Interventions

liposomal daunorubicin citrateDRUG

40 mg/m2 Days 1 and 15 every 28 days x 3 cycles

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

University of Miami Sylvester Comprehensive Cancer Center - Miami

Miami, Florida, United States

Centro de Referencia e Tratamento DST/AIDS

São Paulo, São Paulo, Brazil

Instituto De Infectologia Emilio Ribas Hospital

Cerqueira Cesar - Sao Paulo/SP, Brazil

Outcomes

Primary Outcomes

Effect of liposomal daunorubicin citrate on Kaposi's sarcoma-associated herpes virus (KSHV) viral gene expression in tumors

Time frame: 24-48 hours after the first treatment

Secondary Outcomes

Effect of treatment on KSHV viral gene expression in peripheral blood mononuclear cells

Time frame: 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

Time frame: 24-48 hours after treatment on Day 1/cycle 1, Day 8/cycle 1, and Day 29/cycle 3

Data from ClinicalTrials.gov

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