Overview

Antifungal Therapy for Fever and Neutropenia in Patients Receiving Treatment for Hematologic Cancer

Status:
Completed
Trial end date:
2007-09-01
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Antifungal therapy with liposomal nystatin may reduce fever and neutropenia in patients undergoing treatment for hematologic cancer. It is not yet known whether liposomal nystatin is more effective than standard amphotericin B in treating patients with fever and neutropenia who are receiving chemotherapy for hematologic cancer or bone marrow transplantation for leukemia. PURPOSE: Randomized phase III trial to study the effectiveness of liposomal nystatin compared with standard amphotericin B to treat fever and neutropenia in patients receiving chemotherapy for hematologic cancer or bone marrow transplantation for leukemia.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Aronex Pharmaceuticals
Treatments:
Amphotericin B
Amphotericin B, deoxycholate drug combination
Antifungal Agents
Deoxycholic Acid
Liposomal amphotericin B
Miconazole
Nystatin
Criteria
DISEASE CHARACTERISTICS: Persistent febrile neutropenia associated with 1 of the following
within 3 months prior to entry: Cytotoxic chemotherapy Bone marrow transplantation
Neutropenia defined as either: ANC no greater than 500/mm3 ANC no greater than 1,000/mm3
and expected to decrease to 500/mm3 or less within 2 days after entry Persistent continuous
or spiking fever of at least 38 C No association with administration of pyrogenic
substances No response to at least 72 hours of empiric, broad-spectrum antibacterial
therapy No microbiologically documented source of infection At least 30 days since
documented invasive fungal infection

PATIENT CHARACTERISTICS: Age: 2 and over Performance status: Not specified Life expectancy:
At least 28 days Hematopoietic: Not specified Hepatic: No grade 2 or greater hepatic
impairment Renal: No grade 2 or greater renal impairment No peritoneal dialysis or
hemodialysis Other: No history of severe allergic reaction to polyene antifungal agent No
pregnant or nursing women Negative pregnancy test required of fertile women Effective
contraception required of fertile women during and for 3 months after study

PRIOR CONCURRENT THERAPY: At least 2 weeks since polyene antifungal therapy Concurrent oral
prophylactic antifungal therapy with an azole antifungal agent (e.g., fluconazole,
itraconazole) allowed if patient remains febrile No concurrent azole therapy At least 30
days since other investigational drug or device except investigational formulation of
amphotericin B