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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 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