NCT00427414

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2008

Typical duration for phase_1

Geographic Reach
2 countries

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 29, 2007

Completed
1.6 years until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

April 29, 2015

Status Verified

April 1, 2015

Enrollment Period

2.2 years

First QC Date

January 25, 2007

Last Update Submit

April 28, 2015

Conditions

Sarcoma

Keywords

AIDS-related Kaposi sarcomarecurrent Kaposi sarcoma

Outcome Measures

Primary Outcomes (1)

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

    24-48 hours after the first treatment

Secondary Outcomes (2)

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

    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

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

Study Arms (1)

liposomal daunorubicin citrate

EXPERIMENTAL

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

Drug: liposomal daunorubicin citrate

Interventions

liposomal daunorubicin citrateDRUG

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

Also known as: DaunoXome
liposomal daunorubicin citrate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

University of Miami Sylvester Comprehensive Cancer Center - Miami

Miami, Florida, 33136, United States

Location

Centro de Referencia e Tratamento DST/AIDS

São Paulo, São Paulo, 04121000, Brazil

Location

Instituto De Infectologia Emilio Ribas Hospital

Cerqueira Cesar - Sao Paulo/SP, 01246-900, Brazil

Location

MeSH Terms

Conditions

SarcomaAIDS-related Kaposi sarcomaSarcoma, Kaposi

Interventions

Daunorubicin

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsNeoplasms, Vascular Tissue

Intervention Hierarchy (Ancestors)

AnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Juan Carlos Ramos, MD

    University of Miami Sylvester Comprehensive Cancer Center

    STUDY CHAIR

  • Dirk Dittmer, PhD

    UNC Lineberger Comprehensive Cancer Center

    STUDY CHAIR

  • Tamara Newman Lobato Souza

    Instituto De Infectologia Emilio Ribas Hospital

    PRINCIPAL INVESTIGATOR

  • Luis Carlos Pereira, MD

    Instituto De Infectologia Emilio Ribas Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2007

First Posted

January 29, 2007

Study Start

September 1, 2008

Primary Completion

November 1, 2010

Study Completion

November 1, 2011

Last Updated

April 29, 2015

Record last verified: 2015-04

Locations

US(1)BR(2)