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Antifungal Therapy for Fever and Neutropenia in Patients Receiving Treatment for Hematologic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00002742
Recruitment Status : Completed
First Posted : August 24, 2004
Last Update Posted : March 26, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

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.


Condition or disease Intervention/treatment Phase
Chronic Myeloproliferative Disorders Infection Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Drug: amphotericin B deoxycholate Drug: nystatin Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Supportive Care
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 Start Date : January 1996
Actual Study Completion Date : September 2007






Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002742


Locations
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United States, Arizona
Veterans Affairs Medical Center - Phoenix (Hayden)
Phoenix, Arizona, United States, 85012
United States, Arkansas
Holt-Krock Clinic
Fort Smith, Arkansas, United States, 72901-2418
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202-3591
United States, California
Office of Rosalda Rodriguez, M.D.
Chula Vista, California, United States, 91911
Beckman Research Institute, City of Hope
Duarte, California, United States, 91010
Eisenhower Medical Center
Rancho Mirage, California, United States, 92270
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
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Boston University School of Medicine
Boston, Massachusetts, United States, 02118
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
Columbia Comprehensive Cancer Care Clinic
Columbia, Missouri, United States, 65201
University of Missouri-Columbia Hospital and Clinics
Columbia, Missouri, United States, 65212
Children's Mercy Hospital - Kansas City
Kansas City, Missouri, United States, 64108
Veterans Affairs Medical Center - Kansas City
Kansas City, Missouri, United States, 64128
Antibiotic Research Associates
Kansas City, Missouri, United States, 64132
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
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
St. Vincent's Medical Center of Richmond
Staten Island, New York, United States, 10310
United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
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
United States, Ohio
Summa Health System
Akron, Ohio, United States, 44312
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5065
Cleveland Clinic Cancer Center
Cleveland, Ohio, United States, 44195
Office of Ian Baird & Mark Herbert
Columbus, Ohio, United States, 43215
Infectious Disease Associates of N.W. Ohio
Toledo, Ohio, United States, 43608
Northeast Ohio Infectious Disease Associates, Inc.
Youngstown, Ohio, United States, 45510
Medical Specialists, Inc.
Zanesville, Ohio, United States, 43701
United States, Oklahoma
University of Oklahoma - Department of Pharmacy Practice
Oklahoma City, Oklahoma, United States, 73919
United States, Pennsylvania
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, United States, 19141
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
University of Tennessee Medical Center at Knoxville
Knoxville, Tennessee, United States, 37920
Baptist Clinical Research Services
Memphis, Tennessee, United States, 38103
United States, Texas
Texas Cancer Center at Brackenridge Hospital
Austin, Texas, United States, 78701
University of Texas Southwestern Medical School
Dallas, Texas, United States, 75235-9032
Infectious Disease Associates of Houston
Houston, Texas, United States, 77030
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030
Wilford Hall - 59th Medical Wing
Lackland Air Force Base, Texas, United States, 78236-5300
South Texas Oncology and Hematology
San Antonio, Texas, United States, 78229
Scott and White Clinic
Temple, Texas, United States, 76508
United States, Washington
Infections Limited, P.S.
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
Aronex Pharmaceuticals
Investigators
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Study Chair: David S. Gordon, MD Aronex Pharmaceuticals

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ClinicalTrials.gov Identifier: NCT00002742    
Other Study ID Numbers: CDR0000064660
AR-95-41.356-006
NCI-V96-0845
First Posted: August 24, 2004    Key Record Dates
Last Update Posted: March 26, 2013
Last Verified: July 2007
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:
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Lymphoma
Multiple Myeloma
Neoplasms, Plasma Cell
Preleukemia
Plasmacytoma
Myelodysplastic Syndromes
Myeloproliferative Disorders
Syndrome
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Disease
Pathologic Processes
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Bone Marrow Diseases
Precancerous Conditions
Amphotericin B
Nystatin
Liposomal amphotericin B
Antifungal Agents
Miconazole