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

Tracking Information

First Received Date ^ICMJE

November 1, 1999

Last Updated Date

May 9, 2009

Start Date ^ICMJE

January 1996

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00002742 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Supportive Care, Randomized

Condition ^ICMJE

Chronic Myeloproliferative Disorders
Infection
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes

Intervention ^ICMJE

Drug: amphotericin B deoxycholate
Drug: nystatin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

2 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00002742

Responsible Party

Study ID Numbers ^ICMJE

CDR0000064660, AR-95-41.356-006, NCI-V96-0845

Study Sponsor ^ICMJE

Aronex Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

David S. Gordon, MD

Aronex Pharmaceuticals

Information Provided By

National Cancer Institute (NCI)

Verification Date

July 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP