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Antifungal Therapy for Fever and Neutropenia in Patients Receiving Treatment for Hematologic Cancer
This study has been completed.
First Received: November 1, 1999   Last Updated: May 9, 2009   History of Changes
Sponsor: Aronex Pharmaceuticals
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002742
  Purpose

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.


Condition Intervention Phase
Chronic Myeloproliferative Disorders
Infection
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Drug: amphotericin B deoxycholate
Drug: nystatin
Phase III

Study Type: Interventional
Study Design: Supportive Care, Randomized
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: January 1996
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.

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Persistent febrile neutropenia associated with 1 of the following within 3 months prior to entry: Cytotoxic chemotherapy Bone marrow transplantation Neutropenia defined as either: ANC no greater than 500/mm3 ANC no greater than 1,000/mm3 and expected to decrease to 500/mm3 or less within 2 days after entry Persistent continuous or spiking fever of at least 38 C No association with administration of pyrogenic substances No response to at least 72 hours of empiric, broad-spectrum antibacterial therapy No microbiologically documented source of infection At least 30 days since documented invasive fungal infection

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002742

  Hide Study Locations
Locations
United States, Arizona
Veterans Affairs Medical Center - Phoenix (Hayden)
Phoenix, Arizona, United States, 85012
United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202-3591
Holt-Krock Clinic
Fort Smith, Arkansas, United States, 72901-2418
United States, California
Beckman Research Institute, City of Hope
Duarte, California, United States, 91010
Eisenhower Medical Center
Rancho Mirage, California, United States, 92270
Office of Rosalda Rodriguez, M.D.
Chula Vista, California, United States, 91911
United States, Colorado
University of Colorado Cancer Center
Denver, Colorado, United States, 80262
United States, Connecticut
New Britain General Hospital
New Britain, Connecticut, United States, 06050
United States, District of Columbia
Vincent T. Lombardi Cancer Research Center, Georgetown University
Washington, District of Columbia, United States, 20007
United States, Florida
Sylvester Cancer Center, University of Miami
Miami, Florida, United States, 33136
Tampa Children's Hospital
Tampa, Florida, United States, 33677-4227
United States, Illinois
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, United States, 60612
St. John's Pavilion - Springfield Clinic Research Department
Springfield, Illinois, United States, 62702
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-7357
United States, Louisiana
Lake Charles Medical and Surgical Clinic
Lake Charles, Louisiana, United States, 70601
United States, Maryland
Johns Hopkins Oncology Center
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Boston University School of Medicine
Boston, Massachusetts, United States, 02118
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, Minnesota
United Hospital
Saint Paul, Minnesota, United States, 55102
United States, Missouri
Antibiotic Research Associates
Kansas City, Missouri, United States, 64132
Children's Mercy Hospital - Kansas City
Kansas City, Missouri, United States, 64108
Columbia Comprehensive Cancer Care Clinic
Columbia, Missouri, United States, 65201
University of Missouri-Columbia Hospital and Clinics
Columbia, Missouri, United States, 65212
Veterans Affairs Medical Center - Kansas City
Kansas City, Missouri, United States, 64128
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-3330
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Jersey Shore Cancer Center
Neptune, New Jersey, United States, 07753
Riverview Medical Center
Red Bank, New Jersey, United States, 07701
United States, New York
Albert Einstein Comprehensive Cancer Center
Bronx, New York, United States, 10461
Brooklyn Hospital Center
Brooklyn, New York, United States, 11201
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
St. Vincent's Medical Center of Richmond
Staten Island, New York, United States, 10310
United States, North Carolina
Brookview Research, Inc.
Winston-Salem, North Carolina, United States, 27103
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157-1082
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
United States, Ohio
Cleveland Clinic Cancer Center
Cleveland, Ohio, United States, 44195
Infectious Disease Associates of N.W. Ohio
Toledo, Ohio, United States, 43608
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5065
Office of Ian Baird & Mark Herbert
Columbus, Ohio, United States, 43215
Northeast Ohio Infectious Disease Associates, Inc.
Youngstown, Ohio, United States, 45510
Medical Specialists, Inc.
Zanesville, Ohio, United States, 43701
Summa Health System
Akron, Ohio, United States, 44312
United States, Oklahoma
University of Oklahoma - Department of Pharmacy Practice
Oklahoma City, Oklahoma, United States, 73919
United States, Pennsylvania
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, United States, 19141
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Baptist Clinical Research Services
Memphis, Tennessee, United States, 38103
University of Tennessee Medical Center at Knoxville
Knoxville, Tennessee, United States, 37920
United States, Texas
Infectious Disease Associates of Houston
Houston, Texas, United States, 77030
Scott and White Clinic
Temple, Texas, United States, 76508
South Texas Oncology and Hematology
San Antonio, Texas, United States, 78229
Texas Cancer Center at Brackenridge Hospital
Austin, Texas, United States, 78701
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030
University of Texas Southwestern Medical School
Dallas, Texas, United States, 75235-9032
Wilford Hall - 59th Medical Wing
Lackland Air Force Base, Texas, United States, 78236-5300
United States, Washington
Infections Limited, P.S.
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
Aronex Pharmaceuticals
Investigators
Study Chair: David S. Gordon, MD Aronex Pharmaceuticals
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000064660, AR-95-41.356-006, NCI-V96-0845
Study First Received: November 1, 1999
Last Updated: May 9, 2009
ClinicalTrials.gov Identifier: NCT00002742     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adult Hodgkin lymphoma
adult non-Hodgkin lymphoma
leukemia
childhood non-Hodgkin lymphoma
chronic myeloproliferative disorders
myelodysplastic syndromes
childhood Hodgkin lymphoma
recurrent adult non-Hodgkin lymphoma
infection
multiple myeloma and other plasma cell neoplasms
childhood myelodysplastic syndromes

Additional relevant MeSH terms:
Abelcet
Anti-Infective Agents
Communicable Diseases
Antiprotozoal Agents
Molecular Mechanisms of Pharmacological Action
Precancerous Conditions
Blood Protein Disorders
Nystatin
Paraproteinemias
Liposomal amphotericin B
Infection
Hemostatic Disorders
Membrane Transport Modulators
Anti-Bacterial Agents
Leukemia
Antiparasitic Agents
Preleukemia
Pathologic Processes
Hemorrhagic Disorders
Cholagogues and Choleretics
Therapeutic Uses
Antifungal Agents
Syndrome
Antibiotics, Antifungal
Deoxycholic Acid
Cardiovascular Diseases
Amebicides
Amphotericin B-deoxycholate
Ionophores
Lymphoma

ClinicalTrials.gov processed this record on November 27, 2009