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

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ClinicalTrials.gov Identifier: NCT00427414
Recruitment Status : Terminated (Terminated due to slow accrual.)
First Posted : January 29, 2007
Last Update Posted : April 29, 2015
Sponsor:
Collaborators:
National Cancer Institute (NCI)
The EMMES Corporation
Information provided by (Responsible Party):
AIDS Malignancy Consortium

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Sarcoma Drug: liposomal daunorubicin citrate Phase 1

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Viral Load and Transcription in Kaposi's Sarcoma Patients Treated With Liposomal Anthracyclines
Study Start Date : September 2008
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]
  2. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: AIDS Malignancy Consortium
ClinicalTrials.gov Identifier: NCT00427414     History of Changes
Other Study ID Numbers: AMC-050
U01CA070019 ( U.S. NIH Grant/Contract )
CDR0000526564 ( Other Identifier: NCI )
First Posted: January 29, 2007    Key Record Dates
Last Update Posted: April 29, 2015
Last Verified: April 2015

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