Antifungal Therapy for Fever and Neutropenia in Patients Receiving Treatment for Hematologic Cancer
NCT ID: NCT00002742
Last Updated: 2013-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
INTERVENTIONAL
1996-01-31
2007-09-30
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
SUPPORTIVE_CARE
Interventions
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amphotericin B deoxycholate
nystatin
Eligibility Criteria
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Inclusion Criteria
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
2 Years
ALL
No
Sponsors
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Aronex Pharmaceuticals
INDUSTRY
Principal Investigators
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David S. Gordon, MD
Role: STUDY_CHAIR
Aronex Pharmaceuticals
Locations
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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 D.C., 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 City, New Jersey, United States
Riverview Medical Center
Red Bank, New Jersey, 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
Albert Einstein Comprehensive Cancer Center
The Bronx, 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
Countries
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Other Identifiers
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AR-95-41.356-006
Identifier Type: -
Identifier Source: secondary_id
NCI-V96-0845
Identifier Type: -
Identifier Source: secondary_id
CDR0000064660
Identifier Type: -
Identifier Source: org_study_id
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