Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002742
Status:
COMPLETED
Last Update Posted:
2013-03-26
First Post:
1999-11-01
Brief Title:
Antifungal Therapy for Fever and Neutropenia in Patients Receiving Treatment for Hematologic Cancer
Sponsor:
Aronex Pharmaceuticals
Organization:
National Cancer Institute NCI
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2007-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-V96-0845 | None | None | None |
| AR-95-41356-006 | None | None | None |