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

March 25, 2013 updated by: Aronex Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aronex Pharmaceuticals

Investigators

  • Study Chair: David S. Gordon, MD, Aronex Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1996

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

August 23, 2004

First Posted (Estimate)

August 24, 2004

Study Record Updates

Last Update Posted (Estimate)

March 26, 2013

Last Update Submitted That Met QC Criteria

March 25, 2013

Last Verified

July 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000064660
  • AR-95-41.356-006
  • NCI-V96-0845

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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