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Home > "L" Clinical Trials Conditions > Liposomal Amphotericin B in Treating Granulocytopenia and Persistent Unexplained Fever in Cancer Patients  Liposomal Amphotericin B in Treating Granulocytopenia and Persistent Unexplained Fever in Cancer Patients
Liposomal Amphotericin B in Treating Granulocytopenia and Persistent Unexplained Fever in Cancer Patients
For Condition: Breast Cancer,Hematopoietic and Lymphoid Cancer,Endocrine Cancer,Central Nervous System Cancer,Gastrointestinal Cancer,Kidney Disease
Status: No longer recruiting
Sponsor(s): EORTC Invasive Fungal Infections Cooperative Group ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
P.Ljungman, Study Chair, Huddinge University Hospital
University Medical Center Nijmegen
Nijmegen, , NL-6500 HB
Netherlands
University Hospital - Olomouc
Olomouc, , 775 20
Czech Republic
Hadassah University Hospital
Jerusalem, , 91120
Israel
Athens University-Laikon General Hospital
ATHENS, , 11527
Greece
Section of Infectious Diseases
Ankara, , 06100
Turkey
Universitaetsklinikum Charite
Berlin, , D-10117
Germany
Institut Jules Bordet
Brussels, , 1000
Belgium
Virchow Klinikum Humboldt Universitaet Berlin
Berlin, , D-13353
Germany
CHU de Caen
Caen, , 14033
France
A.Z. St. Jan
Brugge, , 8000
Belgium
Hospital de la Santa Cruz I Sant Pau
Barcelona, , 08025
Spain
Hopital Saint-Louis
Paris, , 75475
France
Clinique Universitaire De Mont-Godinne
Mont-Godinne Yvoir, , 5530
Belgium
Szent Laszlo Korhaz
Budapest, , 1097
Hungary
Hopital Universitaire Erasme
Brussels, , 1070
Belgium
Hippokration Hospital
THESSALONIKI, , 54642
Greece
Hospital De Santo Antonio Dos Capuchos
Lisbon (Lisboa), , 1100
Portugal
U.Z. Gasthuisberg
Leuven, , B-3000
Belgium
National Cancer Institute - Bratislava
Bratislava, , 812 50
Slovakia
Tawam Hospital
Abu Dhabi, ,
United Arab Emirates
Hospital Central de Asturias
Oviedo, , 33006
Spain
Centre Hospitalier Universitaire Henri Mondor
Creteil, , 94010
France
Huddinge University Hospital
Stockholm, , SE-141 86
Sweden
Istituto Nazionale per la Ricerca sul Cancro
Genoa (Genova), , 16132
Italy
Additional Information:
Study ID Numbers: CDR0000067130; EORTC-19951
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003938
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Liposomal Amphotericin B in Treating Granulocytopenia and Persistent Unexplained Fever in Cancer Patients
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