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

Purpose

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.

Condition	Intervention	Phase
Sarcoma	Drug: liposomal daunorubicin citrate	Phase 1


Study Type:	Interventional
Study Design:	Endpoint Classification: Pharmacodynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Pilot Study of Viral Load and Transcription in Kaposi's Sarcoma Patients Treated With Liposomal Anthracyclines

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS Kaposi's Sarcoma Soft Tissue Sarcoma

Drug Information available for: Sodium citrate Citric acid monohydrate Daunorubicin Daunorubicin hydrochloride Daunorubicin citrate

Genetic and Rare Diseases Information Center resources: Malignant Mesenchymal Tumor Soft Tissue Sarcoma Kaposi Sarcoma

U.S. FDA Resources

Further study details as provided by AIDS Malignancy Consortium:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]


Enrollment:	14
Study Start Date:	September 2008
Study Completion Date:	November 2011
Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: liposomal daunorubicin citrate 40 mg/m2 Days 1 and 15 every 28 days x 3 cycles	Drug: liposomal daunorubicin citrate 40 mg/m2 Days 1 and 15 every 28 days x 3 cycles Other Name: DaunoXome

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00427414

Locations


United States, Florida
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States, 33136
Brazil
Instituto De Infectologia Emilio Ribas Hospital
Cerqueira Cesar - Sao Paulo/SP, Brazil, 01246-900
Centro de Referencia e Tratamento DST/AIDS
Sao Paulo, Brazil, 04121000

Sponsors and Collaborators

AIDS Malignancy Consortium

National Cancer Institute (NCI)

The EMMES Corporation

Investigators


Study Chair:	Juan Carlos Ramos, MD	University of Miami Sylvester Comprehensive Cancer Center
Study Chair:	Dirk Dittmer, PhD	UNC Lineberger Comprehensive Cancer Center
Principal Investigator:	Tamara Newman Lobato Souza	Instituto De Infectologia Emilio Ribas Hospital
Principal Investigator:	Luis Carlos Pereira, MD	Instituto De Infectologia Emilio Ribas Hospital

More Information


Responsible Party:	AIDS Malignancy Consortium
ClinicalTrials.gov Identifier:	NCT00427414 History of Changes
Other Study ID Numbers:	AMC-050 U01CA070019 CDR0000526564
Study First Received:	January 25, 2007
Last Updated:	April 28, 2015
Health Authority:	United States: Institutional Review Board Unites States: Federal Government Brazil: Ethics Committee Brazil: Ministry of Health Brazil: National Committee of Ethics in Research

Keywords provided by AIDS Malignancy Consortium:


AIDS-related Kaposi sarcoma recurrent Kaposi sarcoma

Additional relevant MeSH terms:


Sarcoma Sarcoma, Kaposi Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Herpesviridae Infections DNA Virus Infections Virus Diseases Neoplasms, Vascular Tissue Citric Acid Daunorubicin	Anticoagulants Calcium Chelating Agents Chelating Agents Sequestering Agents Molecular Mechanisms of Pharmacological Action Antibiotics, Antineoplastic Antineoplastic Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 23, 2016