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

This study has been terminated.
(Terminated due to slow accrual.)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
AIDS Malignancy Clinical Trials Consortium
ClinicalTrials.gov Identifier:
NCT00427414
First received: January 25, 2007
Last updated: January 29, 2013
Last verified: January 2013
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by AIDS Malignancy Clinical Trials 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 2011 (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
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
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 Clinical Trials Consortium
National Cancer Institute (NCI)
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

No publications provided

Responsible Party: AIDS Malignancy Clinical Trials Consortium
ClinicalTrials.gov Identifier: NCT00427414     History of Changes
Other Study ID Numbers: CDR0000526564, U01CA070019, AMC-050
Study First Received: January 25, 2007
Last Updated: January 29, 2013
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 Clinical Trials Consortium:
AIDS-related Kaposi sarcoma
recurrent Kaposi sarcoma

Additional relevant MeSH terms:
Sarcoma, Kaposi
Sarcoma
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
 Neoplasms
Neoplasms, Vascular Tissue
Daunorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 24, 2013