Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Supportive care	Completed	2 and over	Pharmaceutical / Industry	AR-95-41.356-006 NCI-V96-0845, NCT00002742

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.

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

Expected Enrollment

350 evaluable patients will be studied in this multicenter trial.

Outline

Randomized, double-blind study.

Arm I:  Antifungal Therapy.  Liposomal Nystatin.

Arm II:  Antifungal Therapy.  Amphotericin B, NSC-527017.

Trial Contact Information

Trial Lead Organizations

Aronex Pharmaceuticals, Incorporated

David S. Gordon, MD, Protocol chair		Ph: 281-367-1666

Registry Information
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
Trial Start Date		1996-01-22
Registered in ClinicalTrials.gov		NCT00002742
Date Submitted to PDQ		1996-01-22
Information Last Verified		2007-07-11

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