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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:
Collaborators:
The EMMES Corporation
Information provided by (Responsible Party):
AIDS Malignancy Clinical Trials Consortium
ClinicalTrials.gov Identifier:
NCT00427414
First received: January 25, 2007
Last updated: August 27, 2014
Last verified: August 2014

January 25, 2007
August 27, 2014
September 2008
November 2011   (final data collection date for primary outcome measure)
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 ]
Kaposi's sarcoma-associated herpes virus (KSHV) viral gene expression in tumors
Complete list of historical versions of study NCT00427414 on ClinicalTrials.gov Archive Site
  • 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 ]
  • KSHV viral gene expression in peripheral blood mononuclear cells (PBMCs)
  • KSHV viral load in plasma
Not Provided
Not Provided
 
Liposomal Daunorubicin in Treating Patients With HIV-Related Kaposi's Sarcoma
Pilot Study of Viral Load and Transcription in Kaposi's Sarcoma Patients Treated With Liposomal Anthracyclines

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.

Interventional
Phase 1
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Sarcoma
Drug: liposomal daunorubicin citrate
40 mg/m2 Days 1 and 15 every 28 days x 3 cycles
Other Name: DaunoXome
Experimental: liposomal daunorubicin citrate
40 mg/m2 Days 1 and 15 every 28 days x 3 cycles
Intervention: Drug: liposomal daunorubicin citrate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
14
November 2011
November 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Brazil
 
NCT00427414
AMC-050, U01CA070019, CDR0000526564
No
AIDS Malignancy Clinical Trials Consortium
AIDS Malignancy Clinical Trials Consortium
  • National Cancer Institute (NCI)
  • The EMMES Corporation
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
AIDS Malignancy Clinical Trials Consortium
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP