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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00003938
First received: November 1, 1999
Last updated: September 20, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Cancer
Drug: liposomal amphotericin B
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Supportive Care
Official Title: 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

Resource links provided by NLM:

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U.S. FDA Resources

Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Enrollment: 115
Study Start Date: June 1999
Primary Completion Date: May 2003 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003938

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

Additional Information:
No publications provided

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00003938     History of Changes
Other Study ID Numbers: EORTC-19951, EORTC-19951
Study First Received: November 1, 1999
Last Updated: September 20, 2012
Health Authority: United States: Federal Government

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
stage I adult Hodgkin lymphoma
stage II adult Hodgkin lymphoma
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma
stage IV breast cancer
stage IIIA breast cancer
monoclonal gammopathy of undetermined significance
stage IIIB breast cancer
recurrent childhood acute lymphoblastic leukemia
recurrent adult Hodgkin lymphoma
stage I cutaneous T-cell non-Hodgkin lymphoma
stage II cutaneous T-cell non-Hodgkin lymphoma
stage III cutaneous T-cell non-Hodgkin lymphoma
stage IV cutaneous T-cell non-Hodgkin lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
isolated plasmacytoma of bone
extramedullary plasmacytoma
refractory multiple myeloma
recurrent childhood rhabdomyosarcoma
stage II ovarian epithelial cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
recurrent ovarian epithelial cancer
disseminated neuroblastoma
recurrent neuroblastoma
recurrent Wilms tumor and other childhood kidney tumors
stage 0 chronic lymphocytic leukemia
Waldenstrom macroglobulinemia
stage I multiple myeloma
stage II multiple myeloma

Additional relevant MeSH terms:
Agranulocytosis
Lymphoma, Non-Hodgkin
Lymphoma, Large-Cell, Immunoblastic
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Amphotericin B
Liposomal amphotericin B
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Bacterial Agents
Antifungal Agents

ClinicalTrials.gov processed this record on August 28, 2014