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

Primary Purpose

Chronic Myeloproliferative Disorders, Infection, Leukemia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
amphotericin B deoxycholate
nystatin
Sponsored by
Aronex Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Myeloproliferative Disorders focused on measuring 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

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Veterans Affairs Medical Center - Phoenix (Hayden)
  • Holt-Krock Clinic
  • Arkansas Children's Hospital
  • Office of Rosalda Rodriguez, M.D.
  • Beckman Research Institute, City of Hope
  • Eisenhower Medical Center
  • University of Colorado Cancer Center
  • New Britain General Hospital
  • Vincent T. Lombardi Cancer Research Center, Georgetown University
  • Sylvester Cancer Center, University of Miami
  • Tampa Children's Hospital
  • Rush-Presbyterian-St. Luke's Medical Center
  • St. John's Pavilion - Springfield Clinic Research Department
  • University of Kansas Medical Center
  • Lake Charles Medical and Surgical Clinic
  • Johns Hopkins Oncology Center
  • Dana-Farber Cancer Institute
  • Boston University School of Medicine
  • Barbara Ann Karmanos Cancer Institute
  • Henry Ford Hospital
  • United Hospital
  • Columbia Comprehensive Cancer Care Clinic
  • University of Missouri-Columbia Hospital and Clinics
  • Children's Mercy Hospital - Kansas City
  • Veterans Affairs Medical Center - Kansas City
  • Antibiotic Research Associates
  • University of Nebraska Medical Center
  • Hackensack University Medical Center
  • Jersey Shore Cancer Center
  • Riverview Medical Center
  • Albert Einstein Comprehensive Cancer Center
  • Brooklyn Hospital Center
  • Roswell Park Cancer Institute
  • Long Island Jewish Medical Center
  • St. Vincent's Medical Center of Richmond
  • Duke Comprehensive Cancer Center
  • Brookview Research, Inc.
  • Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
  • Summa Health System
  • Ireland Cancer Center
  • Cleveland Clinic Cancer Center
  • Office of Ian Baird & Mark Herbert
  • Infectious Disease Associates of N.W. Ohio
  • Northeast Ohio Infectious Disease Associates, Inc.
  • Medical Specialists, Inc.
  • University of Oklahoma - Department of Pharmacy Practice
  • University of Pennsylvania Cancer Center
  • Albert Einstein Cancer Center
  • University of Pittsburgh Cancer Institute
  • University of Tennessee Medical Center at Knoxville
  • Baptist Clinical Research Services
  • Texas Cancer Center at Brackenridge Hospital
  • University of Texas Southwestern Medical School
  • Infectious Disease Associates of Houston
  • University of Texas - MD Anderson Cancer Center
  • Wilford Hall - 59th Medical Wing
  • South Texas Oncology and Hematology
  • Scott and White Clinic
  • Infections Limited, P.S.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
March 25, 2013
Sponsor
Aronex Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00002742
Brief Title
Antifungal Therapy for Fever and Neutropenia in Patients Receiving Treatment for Hematologic Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
July 2007
Overall Recruitment Status
Completed
Study Start Date
January 1996 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Aronex Pharmaceuticals

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Myeloproliferative Disorders, Infection, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes
Keywords
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
amphotericin B deoxycholate
Intervention Type
Drug
Intervention Name(s)
nystatin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David S. Gordon, MD
Organizational Affiliation
Aronex Pharmaceuticals
Official's Role
Study Chair
Facility Information:
Facility Name
Veterans Affairs Medical Center - Phoenix (Hayden)
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
Holt-Krock Clinic
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72901-2418
Country
United States
Facility Name
Arkansas Children's Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202-3591
Country
United States
Facility Name
Office of Rosalda Rodriguez, M.D.
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
Beckman Research Institute, City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Eisenhower Medical Center
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
University of Colorado Cancer Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
New Britain General Hospital
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06050
Country
United States
Facility Name
Vincent T. Lombardi Cancer Research Center, Georgetown University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Sylvester Cancer Center, University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Tampa Children's Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33677-4227
Country
United States
Facility Name
Rush-Presbyterian-St. Luke's Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
St. John's Pavilion - Springfield Clinic Research Department
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160-7357
Country
United States
Facility Name
Lake Charles Medical and Surgical Clinic
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
Facility Name
Johns Hopkins Oncology Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Boston University School of Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
United Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
Columbia Comprehensive Cancer Care Clinic
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Facility Name
University of Missouri-Columbia Hospital and Clinics
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
Children's Mercy Hospital - Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Veterans Affairs Medical Center - Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64128
Country
United States
Facility Name
Antibiotic Research Associates
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-3330
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Jersey Shore Cancer Center
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753
Country
United States
Facility Name
Riverview Medical Center
City
Red Bank
State/Province
New Jersey
ZIP/Postal Code
07701
Country
United States
Facility Name
Albert Einstein Comprehensive Cancer Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Brooklyn Hospital Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States
Facility Name
Long Island Jewish Medical Center
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
St. Vincent's Medical Center of Richmond
City
Staten Island
State/Province
New York
ZIP/Postal Code
10310
Country
United States
Facility Name
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Brookview Research, Inc.
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1082
Country
United States
Facility Name
Summa Health System
City
Akron
State/Province
Ohio
ZIP/Postal Code
44312
Country
United States
Facility Name
Ireland Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States
Facility Name
Cleveland Clinic Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Office of Ian Baird & Mark Herbert
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Infectious Disease Associates of N.W. Ohio
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43608
Country
United States
Facility Name
Northeast Ohio Infectious Disease Associates, Inc.
City
Youngstown
State/Province
Ohio
ZIP/Postal Code
45510
Country
United States
Facility Name
Medical Specialists, Inc.
City
Zanesville
State/Province
Ohio
ZIP/Postal Code
43701
Country
United States
Facility Name
University of Oklahoma - Department of Pharmacy Practice
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73919
Country
United States
Facility Name
University of Pennsylvania Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Albert Einstein Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Facility Name
University of Pittsburgh Cancer Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
University of Tennessee Medical Center at Knoxville
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Baptist Clinical Research Services
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
Facility Name
Texas Cancer Center at Brackenridge Hospital
City
Austin
State/Province
Texas
ZIP/Postal Code
78701
Country
United States
Facility Name
University of Texas Southwestern Medical School
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235-9032
Country
United States
Facility Name
Infectious Disease Associates of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Texas - MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Wilford Hall - 59th Medical Wing
City
Lackland Air Force Base
State/Province
Texas
ZIP/Postal Code
78236-5300
Country
United States
Facility Name
South Texas Oncology and Hematology
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Scott and White Clinic
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Infections Limited, P.S.
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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