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

Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Myeloproliferative Disorders; Infection; Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic Syndromes

Intervention: amphotericin B deoxycholate (Drug); nystatin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Aronex Pharmaceuticals

Official(s) and/or principal investigator(s):
David S. Gordon, MD, Study Chair, Affiliation: Aronex Pharmaceuticals


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.

Clinical Details


Study design: Allocation: Randomized, Primary Purpose: Supportive Care

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.


Minimum age: 2 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

Veterans Affairs Medical Center - Phoenix (Hayden), Phoenix, Arizona 85012, United States

Holt-Krock Clinic, Fort Smith, Arkansas 72901-2418, United States

Arkansas Children's Hospital, Little Rock, Arkansas 72202-3591, United States

Office of Rosalda Rodriguez, M.D., Chula Vista, California 91911, United States

Beckman Research Institute, City of Hope, Duarte, California 91010, United States

Eisenhower Medical Center, Rancho Mirage, California 92270, United States

University of Colorado Cancer Center, Denver, Colorado 80262, United States

New Britain General Hospital, New Britain, Connecticut 06050, United States

Vincent T. Lombardi Cancer Research Center, Georgetown University, Washington, District of Columbia 20007, United States

Sylvester Cancer Center, University of Miami, Miami, Florida 33136, United States

Tampa Children's Hospital, Tampa, Florida 33677-4227, United States

Rush-Presbyterian-St. Luke's Medical Center, Chicago, Illinois 60612, United States

St. John's Pavilion - Springfield Clinic Research Department, Springfield, Illinois 62702, United States

University of Kansas Medical Center, Kansas City, Kansas 66160-7357, United States

Lake Charles Medical and Surgical Clinic, Lake Charles, Louisiana 70601, United States

Johns Hopkins Oncology Center, Baltimore, Maryland 21287, United States

Boston University School of Medicine, Boston, Massachusetts 02118, United States

Dana-Farber Cancer Institute, Boston, Massachusetts 02115, United States

Barbara Ann Karmanos Cancer Institute, Detroit, Michigan 48201, United States

Henry Ford Hospital, Detroit, Michigan 48202, United States

United Hospital, Saint Paul, Minnesota 55102, United States

Columbia Comprehensive Cancer Care Clinic, Columbia, Missouri 65201, United States

University of Missouri-Columbia Hospital and Clinics, Columbia, Missouri 65212, United States

Antibiotic Research Associates, Kansas City, Missouri 64132, United States

Children's Mercy Hospital - Kansas City, Kansas City, Missouri 64108, United States

Veterans Affairs Medical Center - Kansas City, Kansas City, Missouri 64128, United States

University of Nebraska Medical Center, Omaha, Nebraska 68198-3330, United States

Hackensack University Medical Center, Hackensack, New Jersey 07601, United States

Jersey Shore Cancer Center, Neptune, New Jersey 07753, United States

Riverview Medical Center, Red Bank, New Jersey 07701, United States

Albert Einstein Comprehensive Cancer Center, Bronx, New York 10461, United States

Brooklyn Hospital Center, Brooklyn, New York 11201, United States

Roswell Park Cancer Institute, Buffalo, New York 14263-0001, United States

Long Island Jewish Medical Center, New Hyde Park, New York 11040, United States

St. Vincent's Medical Center of Richmond, Staten Island, New York 10310, United States

Duke Comprehensive Cancer Center, Durham, North Carolina 27710, United States

Brookview Research, Inc., Winston-Salem, North Carolina 27103, United States

Comprehensive Cancer Center of Wake Forest University Baptist Medical Center, Winston-Salem, North Carolina 27157-1082, United States

Summa Health System, Akron, Ohio 44312, United States

Cleveland Clinic Cancer Center, Cleveland, Ohio 44195, United States

Ireland Cancer Center, Cleveland, Ohio 44106-5065, United States

Office of Ian Baird & Mark Herbert, Columbus, Ohio 43215, United States

Infectious Disease Associates of N.W. Ohio, Toledo, Ohio 43608, United States

Northeast Ohio Infectious Disease Associates, Inc., Youngstown, Ohio 45510, United States

Medical Specialists, Inc., Zanesville, Ohio 43701, United States

University of Oklahoma - Department of Pharmacy Practice, Oklahoma City, Oklahoma 73919, United States

Albert Einstein Cancer Center, Philadelphia, Pennsylvania 19141, United States

University of Pennsylvania Cancer Center, Philadelphia, Pennsylvania 19104, United States

University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania 15213, United States

University of Tennessee Medical Center at Knoxville, Knoxville, Tennessee 37920, United States

Baptist Clinical Research Services, Memphis, Tennessee 38103, United States

Texas Cancer Center at Brackenridge Hospital, Austin, Texas 78701, United States

University of Texas Southwestern Medical School, Dallas, Texas 75235-9032, United States

Infectious Disease Associates of Houston, Houston, Texas 77030, United States

University of Texas - MD Anderson Cancer Center, Houston, Texas 77030, United States

Wilford Hall - 59th Medical Wing, Lackland Air Force Base, Texas 78236-5300, United States

South Texas Oncology and Hematology, San Antonio, Texas 78229, United States

Scott and White Clinic, Temple, Texas 76508, United States

Infections Limited, P.S., Tacoma, Washington 98405, United States

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: January 1996
Last updated: March 25, 2013

Page last updated: August 23, 2015

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