We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00003938
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : September 24, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment Phase
Cancer Drug: liposomal amphotericin B Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 115 participants
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
Study Start Date : June 1999
Primary Completion Date : May 2003

Resource links provided by the National Library of Medicine

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

Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003938


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

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00003938     History of Changes
Other Study ID Numbers: EORTC-19951
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: September 24, 2012
Last Verified: September 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
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Anti-Bacterial Agents
Antifungal Agents