Liposomal Amphotericin B in Treating Granulocytopenia and Persistent Unexplained Fever in Cancer Patients
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cancer
Intervention: liposomal amphotericin B (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: European Organization for Research and Treatment of Cancer Official(s) and/or principal investigator(s):
P. Ljungman, MD, Study Chair, Affiliation: Karolinska University Hospital - Huddinge
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.
Clinical Details
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 design: Supportive Care, Randomized, Active Control
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
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
A.Z. St. Jan, Brugge 8000, Belgium
Clinique Universitaire De Mont-Godinne, Mont-Godinne Yvoir 5530, Belgium
Hopital Universitaire Erasme, Brussels 1070, Belgium
Institut Jules Bordet, Brussels 1000, Belgium
U.Z. Gasthuisberg, Leuven B-3000, Belgium
University Hospital - Olomouc, Olomouc 775 20, Czech Republic
Centre Hospitalier Universitaire Henri Mondor, Creteil 94010, France
CHU de Caen, Caen 14033, France
Hopital Saint-Louis, Paris 75475, France
Universitaetsklinikum Charite, Berlin D-10117, Germany
Virchow Klinikum Humboldt Universitaet Berlin, Berlin D-13353, Germany
Athens University-Laikon General Hospital, Athens 11527, Greece
Hippokration Hospital, Thessaloniki 54642, Greece
Szent Laszlo Korhaz, Budapest 1097, Hungary
Hadassah University Hospital, Jerusalem 91120, Israel
Istituto Nazionale per la Ricerca sul Cancro, Genoa (Genova) 16132, Italy
University Medical Center Nijmegen, Nijmegen NL-6500 HB, Netherlands
Hospital De Santo Antonio Dos Capuchos, Lisbon (Lisboa) 1100, Portugal
National Cancer Institute - Bratislava, Bratislava 812 50, Slovakia
Hospital Central de Asturias, Oviedo 33006, Spain
Hospital de la Santa Cruz I Sant Pau, Barcelona 08025, Spain
Huddinge University Hospital, Stockholm SE-141 86, Sweden
Section of Infectious Diseases, Ankara 06100, Turkey
Tawam Hospital, Abu Dhabi, United Arab Emirates
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: June 1999
Last updated: May 23, 2008
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