Antifungal Therapy for Fever and Neutropenia in Patients Receiving Treatment for Hematologic Cancer
- Conditions
- Chronic Myeloproliferative DisordersInfectionLeukemiaLymphomaMultiple Myeloma and Plasma Cell NeoplasmMyelodysplastic Syndromes
- Registration Number
- NCT00002742
- Lead Sponsor
- Aronex Pharmaceuticals
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (59)
Veterans Affairs Medical Center - Phoenix (Hayden)
🇺🇸Phoenix, Arizona, United States
Holt-Krock Clinic
🇺🇸Fort Smith, Arkansas, United States
Arkansas Children's Hospital
🇺🇸Little Rock, Arkansas, United States
Office of Rosalda Rodriguez, M.D.
🇺🇸Chula Vista, California, United States
Beckman Research Institute, City of Hope
🇺🇸Duarte, California, United States
Eisenhower Medical Center
🇺🇸Rancho Mirage, California, United States
University of Colorado Cancer Center
🇺🇸Denver, Colorado, United States
New Britain General Hospital
🇺🇸New Britain, Connecticut, United States
Vincent T. Lombardi Cancer Research Center, Georgetown University
🇺🇸Washington, District of Columbia, United States
Sylvester Cancer Center, University of Miami
🇺🇸Miami, Florida, United States
Scroll for more (49 remaining)Veterans Affairs Medical Center - Phoenix (Hayden)🇺🇸Phoenix, Arizona, United States