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

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

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
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:

MedlinePlus related topics: Cancer Fever
Genetic and Rare Diseases Information Center resources: AL Amyloidosis B-cell Lymphoma Diffuse Large B-Cell Lymphoma Chronic Lymphocytic Leukemia Leukemia, B-cell, Chronic Myeloid Leukemia Chronic Myeloid Leukemia Lymphosarcoma Multiple Myeloma Acute Myeloid Leukemia Acute Non Lymphoblastic Leukemia Follicular Lymphoma Myelodysplastic Syndromes Hodgkin Lymphoma Mantle Cell Lymphoma Marginal Zone Lymphoma Acute Lymphoblastic Leukemia Chronic Myelomonocytic Leukemia Neuroblastoma Essential Thrombocythemia Myelofibrosis Polycythemia Vera Lymphoblastic Lymphoma Cutaneous T-cell Lymphoma Burkitt Lymphoma Lymphoma, Large-cell Leukemia, T-cell, Chronic Adult T-cell Leukemia/lymphoma Anaplastic Large Cell Lymphoma Angioimmunoblastic T-cell Lymphoma Angioimmunoblastic Lymphadenopathy With Dysproteinemia Ovarian Epithelial Cancer Granulocytopenia Acute Promyelocytic Leukemia Mycosis Fungoides Embryonal Carcinoma Choriocarcinoma Testicular Yolk Sac Tumor Sezary Syndrome Waldenstrom Macroglobulinemia Wilms' Tumor Childhood Acute Lymphoblastic Leukemia Plasmablastic Lymphoma Lymphoma, Large-cell, Immunoblastic Anaplastic Plasmacytoma Hairy Cell Leukemia Testicular Cancer Perlman Syndrome Monoclonal Gammopathy of Undetermined Significance Gestational Trophoblastic Tumor Large Granular Lymphocyte Leukemia Aggressive NK Cell Leukemia Ovarian Germ Cell Tumor Hodgkin Lymphoma, Childhood Testicular Seminoma Chronic Neutrophilic Leukemia Polyembryoma
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:


  • 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.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • Not specified

Performance status:

  • Karnofsky 40-100% OR
  • WHO 0-2

Life expectancy:

  • Not specified


  • See Disease Characteristics


  • Not specified


  • Not specified


  • 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


Biologic therapy:

  • See Disease Characteristics


  • See Disease Characteristics

Endocrine therapy:

  • Not specified


  • Not specified


  • Not specified


  • 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 identifier: NCT00003938

  Show 24 Study Locations
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Study Chair: P. Ljungman, MD Karolinska Institutet
  More Information

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC Identifier: NCT00003938     History of Changes
Other Study ID Numbers: EORTC-19951
Study First Received: November 1, 1999
Last Updated: September 20, 2012

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:
Amphotericin B
Liposomal amphotericin B
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Anti-Bacterial Agents
Antifungal Agents processed this record on April 26, 2017