Liposomal Amphotericin B in Treating Granulocytopenia and Persistent Unexplained Fever in Cancer … (NCT00003938) | Clinical Trial Compass
CompletedPhase 3
Liposomal Amphotericin B in Treating Granulocytopenia and Persistent Unexplained Fever in Cancer Patients
Belgium115 participantsStarted 1999-06
Plain-language 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.
Who can participate
SexALL
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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
Radiother…
Trial details
NCT IDNCT00003938
SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC