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.

Condition	Treatment or Intervention	Phase
adult non-Hodgkin's lymphoma Myeloproliferative Disorders adult Hodgkin's disease childhood non-Hodgkin's lymphoma plasma cell neoplasm Leukemia Myelodysplastic Syndrome Infection recurrent adult non-Hodgkin's lymphoma childhood Hodgkin's disease	Drug: amphotericin B  Drug: nystatin	Phase III

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  2 Years and above

Criteria

PROTOCOL ENTRY 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

--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

--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

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

Study chairs or principal investigators

David S. Gordon,  Study Chair,  Aronex Pharmaceuticals   

Study ID Numbers:  CDR0000064660; AR-95-41.356-006; NCI-V96-0845
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002742
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08