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

Sponsor

Aronex Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00002742

Collaborator

(none)

Locations

140

Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Myeloproliferative Disorders Infection Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes	Drug: amphotericin B deoxycholate Drug: nystatin	Phase 3

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 Design

Study Type:

Interventional

Allocation:

Randomized

Primary Purpose:

Supportive Care

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 Start Date :

Jan 1, 1996

Actual Study Completion Date :

Sep 1, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

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