Spots Global Cancer Trial Database for Antifungal Therapy for Fever and Neutropenia in Patients Receiving Treatment for Hematologic Cancer
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Trial Identification
Brief Title: Antifungal Therapy for Fever and Neutropenia in Patients Receiving Treatment for Hematologic Cancer
Official Title: 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
Study ID: NCT00002742
Study Description
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.
Keywords
Eligibility
Minimum Age: 2 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Tampa Children's Hospital, Tampa, Florida, United States
Rush-Presbyterian-St. Luke's Medical Center, Chicago, Illinois, United States
St. John's Pavilion - Springfield Clinic Research Department, Springfield, Illinois, United States
University of Kansas Medical Center, Kansas City, Kansas, United States
Lake Charles Medical and Surgical Clinic, Lake Charles, Louisiana, United States
Johns Hopkins Oncology Center, Baltimore, Maryland, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Boston University School of Medicine, Boston, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
Henry Ford Hospital, Detroit, Michigan, United States
United Hospital, Saint Paul, Minnesota, United States
Columbia Comprehensive Cancer Care Clinic, Columbia, Missouri, United States
University of Missouri-Columbia Hospital and Clinics, Columbia, Missouri, United States
Children's Mercy Hospital - Kansas City, Kansas City, Missouri, United States
Veterans Affairs Medical Center - Kansas City, Kansas City, Missouri, United States
Antibiotic Research Associates, Kansas City, Missouri, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Jersey Shore Cancer Center, Neptune, New Jersey, United States
Riverview Medical Center, Red Bank, New Jersey, United States
Albert Einstein Comprehensive Cancer Center, Bronx, New York, United States
Brooklyn Hospital Center, Brooklyn, New York, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Long Island Jewish Medical Center, New Hyde Park, New York, United States
St. Vincent's Medical Center of Richmond, Staten Island, New York, United States
Duke Comprehensive Cancer Center, Durham, North Carolina, United States
Brookview Research, Inc., Winston-Salem, North Carolina, United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center, Winston-Salem, North Carolina, United States
Summa Health System, Akron, Ohio, United States
Ireland Cancer Center, Cleveland, Ohio, United States
Cleveland Clinic Cancer Center, Cleveland, Ohio, United States
Office of Ian Baird & Mark Herbert, Columbus, Ohio, United States
Infectious Disease Associates of N.W. Ohio, Toledo, Ohio, United States
Northeast Ohio Infectious Disease Associates, Inc., Youngstown, Ohio, United States
Medical Specialists, Inc., Zanesville, Ohio, United States
University of Oklahoma - Department of Pharmacy Practice, Oklahoma City, Oklahoma, United States
University of Pennsylvania Cancer Center, Philadelphia, Pennsylvania, United States
Albert Einstein Cancer Center, Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, United States
University of Tennessee Medical Center at Knoxville, Knoxville, Tennessee, United States
Baptist Clinical Research Services, Memphis, Tennessee, United States
Texas Cancer Center at Brackenridge Hospital, Austin, Texas, United States
University of Texas Southwestern Medical School, Dallas, Texas, United States
Infectious Disease Associates of Houston, Houston, Texas, United States
University of Texas - MD Anderson Cancer Center, Houston, Texas, United States
Wilford Hall - 59th Medical Wing, Lackland Air Force Base, Texas, United States
South Texas Oncology and Hematology, San Antonio, Texas, United States
Scott and White Clinic, Temple, Texas, United States
Infections Limited, P.S., Tacoma, Washington, United States
Contact Details
Name: David S. Gordon, MD
Affiliation: Aronex Pharmaceuticals
Role: STUDY_CHAIR
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