Clinical trial NCT00002742: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: 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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2004-08-24
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Veterans Affairs Medical Center - Phoenix (Hayden)
state: Arizona
city: Fort Smith
country: United States
facility: Holt-Krock Clinic
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
city: Chula Vista
country: United States
facility: Office of Rosalda Rodriguez, M.D.
state: California
city: Duarte
country: United States
facility: Beckman Research Institute, City of Hope
state: California
city: Rancho Mirage
country: United States
facility: Eisenhower Medical Center
state: California
city: Denver
country: United States
facility: University of Colorado Cancer Center
state: Colorado
city: New Britain
country: United States
facility: New Britain General Hospital
state: Connecticut
city: Washington
country: United States
facility: Vincent T. Lombardi Cancer Research Center, Georgetown University
state: District of Columbia
city: Miami
country: United States
facility: Sylvester Cancer Center, University of Miami
state: Florida
city: Tampa
country: United States
facility: Tampa Children's Hospital
state: Florida
city: Chicago
country: United States
facility: Rush-Presbyterian-St. Luke's Medical Center
state: Illinois
city: Springfield
country: United States
facility: St. John's Pavilion - Springfield Clinic Research Department
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Lake Charles
country: United States
facility: Lake Charles Medical and Surgical Clinic
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins Oncology Center
state: Maryland
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Boston University School of Medicine
state: Massachusetts
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Saint Paul
country: United States
facility: United Hospital
state: Minnesota
city: Columbia
country: United States
facility: Columbia Comprehensive Cancer Care Clinic
state: Missouri
city: Columbia
country: United States
facility: University of Missouri-Columbia Hospital and Clinics
state: Missouri
city: Kansas City
country: United States
facility: Children's Mercy Hospital - Kansas City
state: Missouri
city: Kansas City
country: United States
facility: Veterans Affairs Medical Center - Kansas City
state: Missouri
city: Kansas City
country: United States
facility: Antibiotic Research Associates
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Neptune
country: United States
facility: Jersey Shore Cancer Center
state: New Jersey
city: Red Bank
country: United States
facility: Riverview Medical Center
state: New Jersey
city: Bronx
country: United States
facility: Albert Einstein Comprehensive Cancer Center
state: New York
city: Brooklyn
country: United States
facility: Brooklyn Hospital Center
state: New York
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: New Hyde Park
country: United States
facility: Long Island Jewish Medical Center
state: New York
city: Staten Island
country: United States
facility: St. Vincent's Medical Center of Richmond
state: New York
city: Durham
country: United States
facility: Duke Comprehensive Cancer Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Brookview Research, Inc.
state: North Carolina
city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
state: North Carolina
city: Akron
country: United States
facility: Summa Health System
state: Ohio
city: Cleveland
country: United States
facility: Ireland Cancer Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Cancer Center
state: Ohio
city: Columbus
country: United States
facility: Office of Ian Baird & Mark Herbert
state: Ohio
city: Toledo
country: United States
facility: Infectious Disease Associates of N.W. Ohio
state: Ohio
city: Youngstown
country: United States
facility: Northeast Ohio Infectious Disease Associates, Inc.
state: Ohio
city: Zanesville
country: United States
facility: Medical Specialists, Inc.
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma - Department of Pharmacy Practice
state: Oklahoma
city: Philadelphia
country: United States
facility: University of Pennsylvania Cancer Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Albert Einstein Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Cancer Institute
state: Pennsylvania
city: Knoxville
country: United States
facility: University of Tennessee Medical Center at Knoxville
state: Tennessee
city: Memphis
country: United States
facility: Baptist Clinical Research Services
state: Tennessee
city: Austin
country: United States
facility: Texas Cancer Center at Brackenridge Hospital
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical School
state: Texas
city: Houston
country: United States
facility: Infectious Disease Associates of Houston
state: Texas
city: Houston
country: United States
facility: University of Texas - MD Anderson Cancer Center
state: Texas
city: Lackland Air Force Base
country: United States
facility: Wilford Hall - 59th Medical Wing
state: Texas
city: San Antonio
country: United States
facility: South Texas Oncology and Hematology
state: Texas
city: Temple
country: United States
facility: Scott and White Clinic
state: Texas
city: Tacoma
country: United States
facility: Infections Limited, P.S.
state: Washington
Study officials:
affiliation: Aronex Pharmaceuticals
name: David S. Gordon, MD
role: STUDY_CHAIR
References: