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

Last updated: March 25, 2013
Sponsor: Aronex Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Leukemia

Multiple Myeloma

Cancer/tumors

Treatment

N/A

Clinical Study ID

NCT00002742
CDR0000064660
NCI-V96-0845
AR-95-41.356-006
  • Ages > 2
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Study Design

Study Start date:
January 01, 1996
Estimated Completion Date:
September 30, 2007

Study 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.

Connect with a study center

  • Veterans Affairs Medical Center - Phoenix (Hayden)

    Phoenix, Arizona 85012
    United States

    Site Not Available

  • Holt-Krock Clinic

    Fort Smith, Arkansas 72901-2418
    United States

    Site Not Available

  • Arkansas Children's Hospital

    Little Rock, Arkansas 72202-3591
    United States

    Site Not Available

  • Office of Rosalda Rodriguez, M.D.

    Chula Vista, California 91911
    United States

    Site Not Available

  • Beckman Research Institute, City of Hope

    Duarte, California 91010
    United States

    Site Not Available

  • Eisenhower Medical Center

    Rancho Mirage, California 92270
    United States

    Site Not Available

  • University of Colorado Cancer Center

    Denver, Colorado 80262
    United States

    Site Not Available

  • New Britain General Hospital

    New Britain, Connecticut 06050
    United States

    Site Not Available

  • Vincent T. Lombardi Cancer Research Center, Georgetown University

    Washington, District of Columbia 20007
    United States

    Site Not Available

  • Sylvester Cancer Center, University of Miami

    Miami, Florida 33136
    United States

    Site Not Available

  • Tampa Children's Hospital

    Tampa, Florida 33677-4227
    United States

    Site Not Available

  • Rush-Presbyterian-St. Luke's Medical Center

    Chicago, Illinois 60612
    United States

    Site Not Available

  • St. John's Pavilion - Springfield Clinic Research Department

    Springfield, Illinois 62702
    United States

    Site Not Available

  • University of Kansas Medical Center

    Kansas City, Kansas 66160-7357
    United States

    Site Not Available

  • Lake Charles Medical and Surgical Clinic

    Lake Charles, Louisiana 70601
    United States

    Site Not Available

  • Johns Hopkins Oncology Center

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Boston University School of Medicine

    Boston, Massachusetts 02118
    United States

    Site Not Available

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan 48201
    United States

    Site Not Available

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Site Not Available

  • United Hospital

    Saint Paul, Minnesota 55102
    United States

    Site Not Available

  • Columbia Comprehensive Cancer Care Clinic

    Columbia, Missouri 65201
    United States

    Site Not Available

  • University of Missouri-Columbia Hospital and Clinics

    Columbia, Missouri 65212
    United States

    Site Not Available

  • Antibiotic Research Associates

    Kansas City, Missouri 64132
    United States

    Site Not Available

  • Children's Mercy Hospital - Kansas City

    Kansas City, Missouri 64108
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Kansas City

    Kansas City, Missouri 64128
    United States

    Site Not Available

  • University of Nebraska Medical Center

    Omaha, Nebraska 68198-3330
    United States

    Site Not Available

  • Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Jersey Shore Cancer Center

    Neptune, New Jersey 07753
    United States

    Site Not Available

  • Riverview Medical Center

    Red Bank, New Jersey 07701
    United States

    Site Not Available

  • Albert Einstein Comprehensive Cancer Center

    Bronx, New York 10461
    United States

    Site Not Available

  • Brooklyn Hospital Center

    Brooklyn, New York 11201
    United States

    Site Not Available

  • Roswell Park Cancer Institute

    Buffalo, New York 14263-0001
    United States

    Site Not Available

  • Long Island Jewish Medical Center

    New Hyde Park, New York 11040
    United States

    Site Not Available

  • St. Vincent's Medical Center of Richmond

    Staten Island, New York 10310
    United States

    Site Not Available

  • Duke Comprehensive Cancer Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Brookview Research, Inc.

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Comprehensive Cancer Center of Wake Forest University Baptist Medical Center

    Winston-Salem, North Carolina 27157-1082
    United States

    Site Not Available

  • Summa Health System

    Akron, Ohio 44312
    United States

    Site Not Available

  • Cleveland Clinic Cancer Center

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Ireland Cancer Center

    Cleveland, Ohio 44106-5065
    United States

    Site Not Available

  • Office of Ian Baird & Mark Herbert

    Columbus, Ohio 43215
    United States

    Site Not Available

  • Infectious Disease Associates of N.W. Ohio

    Toledo, Ohio 43608
    United States

    Site Not Available

  • Northeast Ohio Infectious Disease Associates, Inc.

    Youngstown, Ohio 45510
    United States

    Site Not Available

  • Medical Specialists, Inc.

    Zanesville, Ohio 43701
    United States

    Site Not Available

  • University of Oklahoma - Department of Pharmacy Practice

    Oklahoma City, Oklahoma 73919
    United States

    Site Not Available

  • Albert Einstein Cancer Center

    Philadelphia, Pennsylvania 19141
    United States

    Site Not Available

  • University of Pennsylvania Cancer Center

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • University of Pittsburgh Cancer Institute

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • University of Tennessee Medical Center at Knoxville

    Knoxville, Tennessee 37920
    United States

    Site Not Available

  • Baptist Clinical Research Services

    Memphis, Tennessee 38103
    United States

    Site Not Available

  • Texas Cancer Center at Brackenridge Hospital

    Austin, Texas 78701
    United States

    Site Not Available

  • University of Texas Southwestern Medical School

    Dallas, Texas 75235-9032
    United States

    Site Not Available

  • Infectious Disease Associates of Houston

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Texas - MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • Wilford Hall - 59th Medical Wing

    Lackland Air Force Base, Texas 78236-5300
    United States

    Site Not Available

  • South Texas Oncology and Hematology

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Scott and White Clinic

    Temple, Texas 76508
    United States

    Site Not Available

  • Infections Limited, P.S.

    Tacoma, Washington 98405
    United States

    Site Not Available

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