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
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.
Interventional
Allocation: Randomized, Primary Purpose: Supportive Care
David S. Gordon, MD
Study Chair
Aronex Pharmaceuticals
United States: Federal Government
CDR0000064660
NCT00002742
January 1996
September 2007
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Antibiotic Research Associates | Kansas City, Missouri 64132 |
Albert Einstein Comprehensive Cancer Center | Bronx, New York 10461 |
University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
University of Colorado Cancer Center | Denver, Colorado 80262 |
Vincent T. Lombardi Cancer Research Center, Georgetown University | Washington, District of Columbia 20007 |
Rush-Presbyterian-St. Luke's Medical Center | Chicago, Illinois 60612 |
Johns Hopkins Oncology Center | Baltimore, Maryland 21287 |
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center | Winston-Salem, North Carolina 27157-1082 |
Cleveland Clinic Cancer Center | Cleveland, Ohio 44195 |
Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
University of Pennsylvania Cancer Center | Philadelphia, Pennsylvania 19104 |
Sylvester Cancer Center, University of Miami | Miami, Florida 33136 |
Brookview Research, Inc. | Winston-Salem, North Carolina 27103 |
University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15213 |
United Hospital | St. Paul, Minnesota 55102 |
Henry Ford Hospital | Detroit, Michigan 48202 |
Beckman Research Institute, City of Hope | Los Angeles, California 91010 |
Albert Einstein Cancer Center | Philadelphia, Pennsylvania 19141 |
Wilford Hall - 59th Medical Wing | Lackland Air Force Base, Texas 78236-5300 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
Veterans Affairs Medical Center - Kansas City | Kansas City, Missouri 64128 |
Veterans Affairs Medical Center - Phoenix (Hayden) | Phoenix, Arizona 85012 |
University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |
Hackensack University Medical Center | Hackensack, New Jersey 07601 |
Riverview Medical Center | Red Bank, New Jersey 07701 |
Tampa Children's Hospital | Tampa, Florida 33677-4227 |
University of Missouri-Columbia Hospital and Clinics | Columbia, Missouri 65212 |
Brooklyn Hospital Center | Brooklyn, New York 11201 |
Children's Mercy Hospital - Kansas City | Kansas City, Missouri 64108 |
University of Texas Southwestern Medical School | Dallas, Texas 75235-9032 |
Holt-Krock Clinic | Fort Smith, Arkansas 72901-2418 |
Arkansas Children's Hospital | Little Rock, Arkansas 72202-3591 |
Office of Rosalda Rodriguez, M.D. | Chula Vista, California 91911 |
Eisenhower Medical Center | Rancho Mirage, California 92270 |
New Britain General Hospital | New Britain, Connecticut 06050 |
St. John's Pavilion - Springfield Clinic Research Department | Springfield, Illinois 62702 |
Lake Charles Medical and Surgical Clinic | Lake Charles, Louisiana 70601 |
Boston University School of Medicine | Boston, Massachusetts 02118 |
Columbia Comprehensive Cancer Care Clinic | Columbia, Missouri 65201 |
Jersey Shore Cancer Center | Neptune, New Jersey 07753 |
Long Island Jewish Medical Center | New Hyde Park, New York 11040 |
St. Vincent's Medical Center of Richmond | Staten Island, New York 10310 |
Summa Health System | Akron, Ohio 44312 |
Office of Ian Baird & Mark Herbert | Columbus, Ohio 43215 |
Infectious Disease Associates of N.W. Ohio | Toledo, Ohio 43608 |
Northeast Ohio Infectious Disease Associates, Inc. | Youngstown, Ohio 45510 |
Medical Specialists, Inc. | Zanesville, Ohio 43701 |
University of Oklahoma - Department of Pharmacy Practice | Oklahoma City, Oklahoma 73919 |
University of Tennessee Medical Center at Knoxville | Knoxville, Tennessee 37920 |
Baptist Clinical Research Services | Memphis, Tennessee 38103 |
Texas Cancer Center at Brackenridge Hospital | Austin, Texas 78701 |
Infectious Disease Associates of Houston | Houston, Texas 77030 |
South Texas Oncology and Hematology | San Antonio, Texas 78229 |
Scott and White Clinic | Temple, Texas 76508 |
Infections Limited, P.S. | Tacoma, Washington 98405 |