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

Primary Purpose

Sarcoma

Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
liposomal daunorubicin citrate
Sponsored by
AIDS Malignancy Consortium
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoma focused on measuring AIDS-related Kaposi sarcoma, recurrent Kaposi sarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Miami Sylvester Comprehensive Cancer Center - Miami
  • Instituto De Infectologia Emilio Ribas Hospital
  • Centro de Referencia e Tratamento DST/AIDS

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

liposomal daunorubicin citrate

Arm Description

40 mg/m2 Days 1 and 15 every 28 days x 3 cycles

Outcomes

Primary Outcome Measures

Effect of liposomal daunorubicin citrate on Kaposi's sarcoma-associated herpes virus (KSHV) viral gene expression in tumors

Secondary Outcome Measures

Effect of treatment on KSHV viral gene expression in peripheral blood mononuclear cells
Effect of treatment on KSHV viral load in plasma

Full Information

First Posted
January 25, 2007
Last Updated
April 28, 2015
Sponsor
AIDS Malignancy Consortium
Collaborators
National Cancer Institute (NCI), The Emmes Company, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00427414
Brief Title
Liposomal Daunorubicin in Treating Patients With HIV-Related Kaposi's Sarcoma
Official Title
Pilot Study of Viral Load and Transcription in Kaposi's Sarcoma Patients Treated With Liposomal Anthracyclines
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Terminated
Why Stopped
Terminated due to slow accrual.
Study Start Date
September 2008 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AIDS Malignancy Consortium
Collaborators
National Cancer Institute (NCI), The Emmes Company, LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma
Keywords
AIDS-related Kaposi sarcoma, recurrent Kaposi sarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
liposomal daunorubicin citrate
Arm Type
Experimental
Arm Description
40 mg/m2 Days 1 and 15 every 28 days x 3 cycles
Intervention Type
Drug
Intervention Name(s)
liposomal daunorubicin citrate
Other Intervention Name(s)
DaunoXome
Intervention Description
40 mg/m2 Days 1 and 15 every 28 days x 3 cycles
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan Carlos Ramos, MD
Organizational Affiliation
University of Miami Sylvester Comprehensive Cancer Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Dirk Dittmer, PhD
Organizational Affiliation
UNC Lineberger Comprehensive Cancer Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Tamara Newman Lobato Souza
Organizational Affiliation
Instituto De Infectologia Emilio Ribas Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Luis Carlos Pereira, MD
Organizational Affiliation
Instituto De Infectologia Emilio Ribas Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami Sylvester Comprehensive Cancer Center - Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Instituto De Infectologia Emilio Ribas Hospital
City
Cerqueira Cesar - Sao Paulo/SP
ZIP/Postal Code
01246-900
Country
Brazil
Facility Name
Centro de Referencia e Tratamento DST/AIDS
City
Sao Paulo
ZIP/Postal Code
04121000
Country
Brazil

12. IPD Sharing Statement

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

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