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

April 28, 2015 updated by: AIDS Malignancy Consortium

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • DaunoXome

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
24-48 hours after the first treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
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
24-48 hours after treatment on Day 1/cycle 1, Day 8/cycle 1, and Day 29/cycle 3
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
24-48 hours after treatment on Day 1/cycle 1, Day 8/cycle 1, and Day 29/cycle 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AIDS Malignancy Consortium

Collaborators

National Cancer Institute (NCI)
The Emmes Company, LLC

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (ACTUAL)

November 1, 2010

Study Completion (ACTUAL)

November 1, 2011

Study Registration Dates

First Submitted

January 25, 2007

First Submitted That Met QC Criteria

January 25, 2007

First Posted (ESTIMATE)

January 29, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

April 29, 2015

Last Update Submitted That Met QC Criteria

April 28, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMC-050
  • U01CA070019 (U.S. NIH Grant/Contract)
  • CDR0000526564 (OTHER: NCI)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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