Trials / Completed
CompletedNCT00002742
Antifungal Therapy for Fever and Neutropenia in Patients Receiving Treatment for Hematologic Cancer
A PROSPECTIVE RANDOMIZED, DOUBLE-BLIND, COMPARATIVE, MULTICENTER STUDY TO EVALUATE EFFICACY AND SAFETY OF NYSTATIN AND AMPHOTERICIN B FOR EMPIRIC ANTIFUNGAL TREATMENT IN NEUTROPENIC PATIENTS
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Aronex Pharmaceuticals · Industry
- Sex
- All
- Age
- 2 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
OBJECTIVES: I. Compare the efficacy of liposomal nystatin vs standard amphotericin B for the empiric treatment of persistent febrile neutropenic patients. II. Compare the incidence of drug-related toxicity or impairment and infusion-related toxicity in patients treated with liposomal nystatin vs standard amphotericin B. III. Determine the pharmacokinetics of liposomal nystatin. OUTLINE: Randomized, double-blind study. Arm I: Antifungal Therapy. Liposomal Nystatin. Arm II: Antifungal Therapy. Amphotericin B, NSC-527017. PROJECTED ACCRUAL: 350 evaluable patients will be studied in this multicenter trial.
Conditions
- Chronic Myeloproliferative Disorders
- Infection
- Leukemia
- Lymphoma
- Multiple Myeloma and Plasma Cell Neoplasm
- Myelodysplastic Syndromes
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | amphotericin B deoxycholate | |
| DRUG | nystatin |
Timeline
- Start date
- 1996-01-01
- Completion
- 2007-09-01
- First posted
- 2004-08-24
- Last updated
- 2013-03-26
Locations
59 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00002742. Inclusion in this directory is not an endorsement.