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
liposomal amphotericin B
Lymphadenopathy+144
+ Urogenital Diseases
+ Genital Diseases
Supportive Care Study
Summary
Study start date: June 1, 1999
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.115 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Supportive Care Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 24 locations
Institut Jules Bordet
Brussels, BelgiumHopital Universitaire Erasme
Brussels, BelgiumU.Z. Gasthuisberg
Leuven, Belgium