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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


Phase 3
2 Years
N/A
Not Enrolling
Both
Chronic Myeloproliferative Disorders, Infection, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes

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Trial Information

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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Supportive Care

Principal Investigator

David S. Gordon, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Aronex Pharmaceuticals

Authority:

United States: Federal Government

Study ID:

CDR0000064660

NCT ID:

NCT00002742

Start Date:

January 1996

Completion Date:

September 2007

Related Keywords:

  • Chronic Myeloproliferative Disorders
  • Infection
  • Leukemia
  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
  • 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
  • Neoplasms
  • Leukemia
  • Lymphoma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma
  • Myelodysplastic Syndromes
  • Preleukemia
  • Myeloproliferative Disorders

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Antibiotic Research AssociatesKansas City, Missouri  64132
Albert Einstein Comprehensive Cancer CenterBronx, New York  10461
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Colorado Cancer CenterDenver, Colorado  80262
Vincent T. Lombardi Cancer Research Center, Georgetown UniversityWashington, District of Columbia  20007
Rush-Presbyterian-St. Luke's Medical CenterChicago, Illinois  60612
Johns Hopkins Oncology CenterBaltimore, Maryland  21287
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Comprehensive Cancer Center of Wake Forest University Baptist Medical CenterWinston-Salem, North Carolina  27157-1082
Cleveland Clinic Cancer CenterCleveland, Ohio  44195
Ireland Cancer CenterCleveland, Ohio  44106-5065
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104
Sylvester Cancer Center, University of MiamiMiami, Florida  33136
Brookview Research, Inc.Winston-Salem, North Carolina  27103
University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15213
United HospitalSt. Paul, Minnesota  55102
Henry Ford HospitalDetroit, Michigan  48202
Beckman Research Institute, City of HopeLos Angeles, California  91010
Albert Einstein Cancer CenterPhiladelphia, Pennsylvania  19141
Wilford Hall - 59th Medical WingLackland Air Force Base, Texas  78236-5300
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
University of Kansas Medical CenterKansas City, Kansas  66160-7353
Veterans Affairs Medical Center - Kansas CityKansas City, Missouri  64128
Veterans Affairs Medical Center - Phoenix (Hayden)Phoenix, Arizona  85012
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Hackensack University Medical CenterHackensack, New Jersey  07601
Riverview Medical CenterRed Bank, New Jersey  07701
Tampa Children's HospitalTampa, Florida  33677-4227
University of Missouri-Columbia Hospital and ClinicsColumbia, Missouri  65212
Brooklyn Hospital CenterBrooklyn, New York  11201
Children's Mercy Hospital - Kansas CityKansas City, Missouri  64108
University of Texas Southwestern Medical SchoolDallas, Texas  75235-9032
Holt-Krock ClinicFort Smith, Arkansas  72901-2418
Arkansas Children's HospitalLittle Rock, Arkansas  72202-3591
Office of Rosalda Rodriguez, M.D.Chula Vista, California  91911
Eisenhower Medical CenterRancho Mirage, California  92270
New Britain General HospitalNew Britain, Connecticut  06050
St. John's Pavilion - Springfield Clinic Research DepartmentSpringfield, Illinois  62702
Lake Charles Medical and Surgical ClinicLake Charles, Louisiana  70601
Boston University School of MedicineBoston, Massachusetts  02118
Columbia Comprehensive Cancer Care ClinicColumbia, Missouri  65201
Jersey Shore Cancer CenterNeptune, New Jersey  07753
Long Island Jewish Medical CenterNew Hyde Park, New York  11040
St. Vincent's Medical Center of RichmondStaten Island, New York  10310
Summa Health SystemAkron, Ohio  44312
Office of Ian Baird & Mark HerbertColumbus, Ohio  43215
Infectious Disease Associates of N.W. OhioToledo, Ohio  43608
Northeast Ohio Infectious Disease Associates, Inc.Youngstown, Ohio  45510
Medical Specialists, Inc.Zanesville, Ohio  43701
University of Oklahoma - Department of Pharmacy PracticeOklahoma City, Oklahoma  73919
University of Tennessee Medical Center at KnoxvilleKnoxville, Tennessee  37920
Baptist Clinical Research ServicesMemphis, Tennessee  38103
Texas Cancer Center at Brackenridge HospitalAustin, Texas  78701
Infectious Disease Associates of HoustonHouston, Texas  77030
South Texas Oncology and HematologySan Antonio, Texas  78229
Scott and White ClinicTemple, Texas  76508
Infections Limited, P.S.Tacoma, Washington  98405