Liposomal Amphotericin B in Treating Granulocytopenia and Persistent Unexplained Fever in Cancer Patients

September 20, 2012 updated by: European Organisation for Research and Treatment of Cancer - EORTC

A Strategic Study to Determine the Optimal Moment to Initiate Systemic Antifungal Therapy With Ambisome in Granulocytopenic Cancer Patients With Unexplained Fever Refractory to Empirical Antibacterials

RATIONALE: Liposomal amphotericin B may be effective in controlling fever and granulocytopenia. It is not yet known which regimen of liposomal amphotericin B is more effective in treating cancer patients who have these conditions.

PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of liposomal amphotericin B in treating granulocytopenia and fever in cancer patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Compare the efficacy and side effects of amphotericin B-liposomal formulation initiated 72-84 hours vs 144-156 hours after onset of a febrile episode in cancer patients with granulocytopenia and persistent unexplained fever refractory to antibacterials.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to antifungal prophylaxis (yes vs no) and type of underlying condition. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive amphotericin B-liposomal formulation IV over 1 hour on day 3 of febrile neutropenia.
  • Arm II: Patients receive amphotericin B-liposomal formulation IV over 1 hour on day 6 of febrile neutropenia.

Treatment continues until signs and symptoms of the fungal infection appear or febrile neutropenia has resolved. Persistently neutropenic patients receive treatment for at least 10 days or until another cause of infection is determined.

Patients are followed weekly for 3 weeks.

PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study.

Study Type

Interventional

Enrollment (Actual)

115

Phase

  • Phase 3

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

  • Belgium
      • Brugge, Belgium, 8000
        • A.Z. St. Jan
      • Brussels, Belgium, 1000
        • Institut Jules Bordet
      • Brussels, Belgium, 1070
        • Hopital Universitaire Erasme
      • Leuven, Belgium, B-3000
        • U.Z. Gasthuisberg
      • Mont-Godinne Yvoir, Belgium, 5530
        • Clinique Universitaire De Mont-Godinne
  • Czech Republic
      • Olomouc, Czech Republic, 775 20
        • University Hospital - Olomouc
  • France
      • Caen, France, 14033
        • CHU de Caen
      • Creteil, France, 94010
        • Centre Hospitalier Universitaire Henri Mondor
      • Paris, France, 75475
        • Hopital Saint-Louis
  • Germany
      • Berlin, Germany, D-10117
        • Universitaetsklinikum Charite
      • Berlin, Germany, D-13353
        • Virchow Klinikum Humboldt Universitaet Berlin
  • Greece
      • Athens, Greece, 11527
        • Athens University-Laikon General Hospital
      • Thessaloniki, Greece, 54642
        • Hippokration Hospital
  • Hungary
      • Budapest, Hungary, 1097
        • Szent Laszlo Korhaz
  • Israel
      • Jerusalem, Israel, 91120
        • Hadassah University Hospital
  • Italy
      • Genoa (Genova), Italy, 16132
        • Istituto nazionale Per la Ricerca sul Cancro
  • Netherlands
      • Nijmegen, Netherlands, NL-6500 HB
        • University Medical Center Nijmegen
  • Portugal
      • Lisbon (Lisboa), Portugal, 1100
        • Hospital De Santo Antonio Dos Capuchos
  • Slovakia
      • Bratislava, Slovakia, 812 50
        • National Cancer Institute - Bratislava
  • Spain
      • Barcelona, Spain, 08025
        • Hospital de la Santa Cruz i Sant Pau
      • Oviedo, Spain, 33006
        • Hospital Central de Asturias
  • Sweden
      • Stockholm, Sweden, SE-141 86
        • Huddinge University Hospital
  • Turkey
      • Ankara, Turkey, 06100
        • Section of Infectious Diseases
  • United Arab Emirates
      • Abu Dhabi, United Arab Emirates
        • Tawam Hospital

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Hematologic malignancy or solid tumor
  • Must be undergoing remission induction and/or consolidation therapy for hematologic malignancy only OR
  • Must be undergoing allogeneic or autologous bone marrow transplantation
  • Granulocyte count less than 500/mm^3 and profound granulocytopenia expected to last for greater than 5 days
  • Fever (greater than 38.5 degrees C) refractory for greater than 72 hours and less than 84 hours to broad spectrum antimicrobials, after exclusion of current bacterial, fungal, viral, parasitic, and mycobacterial infections
  • Peripheral blood cultures and central venous catheter cultures negative for infections
  • No microbiological documentation of a bacterial infection (e.g., abscess at catheter site)
  • No invasive fungal infection
  • No probable noninfectious cause of fever

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • Karnofsky 40-100% OR
  • WHO 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • See Disease Characteristics

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • No prior anaphylactic reaction to amphotericin B
  • No psychological, familial, sociological, or geographical conditions that would prevent compliance
  • Not pregnant or nursing
  • Normal chest X-ray or normal high resolution CT scan of the lungs

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics

Chemotherapy:

  • See Disease Characteristics

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Other:

  • No concurrent active systemic antifungal agents or antifungal prophylaxis (e.g., azoles or polyenes)
  • No prior IV amphotericin B during same neutropenic episode
  • No change in antibacterial regimen within 48 hours prior to study

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: Supportive Care
  • Allocation: Randomized

Collaborators and Investigators

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

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

  • Study Chair: P. Ljungman, MD, Karolinska Institutet

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

June 1, 1999

Primary Completion (Actual)

May 1, 2003

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

September 24, 2012

Last Update Submitted That Met QC Criteria

September 20, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-19951

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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