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

Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00427414
• Other study ID #: AMC-050
• Secondary ID: U01CA070019CDR00
• Status: Terminated
• Phase: Phase 1
• First received: January 25, 2007
• Last updated: April 28, 2015
• Start date: September 2008
• Est. completion date: November 2011

Study information

• Verified date: April 2015
• Source: AIDS Malignancy Consortium
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnites States: Federal GovernmentBrazil: Ethics CommitteeBrazil: Ministry of HealthBrazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: November 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sarcoma
• Sarcoma, Kaposi

Intervention

Drug:
• liposomal daunorubicin citrate
40 mg/m2 Days 1 and 15 every 28 days x 3 cycles

Locations

Country	Name	City	State
Brazil	Instituto De Infectologia Emilio Ribas Hospital	Cerqueira Cesar - Sao Paulo/SP
Brazil	Centro de Referencia e Tratamento DST/AIDS	Sao Paulo
United States	University of Miami Sylvester Comprehensive Cancer Center - Miami	Miami	Florida

Sponsors (3)

Lead Sponsor	Collaborator
AIDS Malignancy Consortium	National Cancer Institute (NCI), The EMMES Corporation

Countries where clinical trial is conducted

United States,  Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No