NCT00003315

Liposomal Amphotericin B With or Without Sargramostim in Treating Patients With Invasive Fungal Infection

Supplementary Protocol for Patients With Invasive Fungal Infection, Entered Into AML 11, AML 12 and UKALL XII (Or Their Successors)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Medical Research Council · Other Government
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs like liposomal amphotericin B may be able to relieve fungal infection which can be a side effect of chemotherapy. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. It is not yet known whether receiving liposomal amphotericin B plus sargramostim is more effective than receiving liposomal amphotericin B alone in treating patients with invasive fungal infection. PURPOSE: Randomized double-blinded phase III trial to compare the effectiveness of liposomal amphotericin B with or without sargramostim in treating patients with invasive fungal infection.

Detailed description

OBJECTIVES: I. Evaluate the benefit of the cytokine sargramostim (GM-CSF) in resolving suspected or proven fungal infections in patients treated with systemic antifungal therapy (liposomal amphotericin B) who have been entered on protocols MRC-LEUK-AML11, AML12 or UKALLXII. II. Assess, in vitro, the effect of GM-CSF on monocyte function on cells taken from these patients. OUTLINE: This is a double blind, supportive care study for patients on MRC-LEUK-AML11, AML12, or UKALLXII (or their successors). Patients are stratified according to proven or suspected fungal infection. Patients receive daily doses of intravenous liposomal amphotericin B based on stratification. All patients are then randomized to also receive either sargramostim (GM-CSF) (arm I) or a placebo (arm II) by subcutaneous injections (intravenous infusion over 4-6 hours is permitted if subcutaneous route is unacceptable). Treatment continues for 42 days. Some patients with localized lesions that clinically improve should be considered for surgical removal of the residual lesion. Patients may continue therapy after 42 days at the physician's discretion. Patients are assessed weekly until the end of study (particularly on day 28 and at end of study). PROJECTED ACCRUAL: There will be 200 patients (100 in each arm) accrued into this study.

Conditions

• Infection

Interventions

Type	Name	Description
BIOLOGICAL	sargramostim
DRUG	liposomal amphotericin B

Timeline

• Start date: 1997-07-01
• Completion: 1997-12-01
• First posted: 2004-08-26
• Last updated: 2013-12-04

Locations

1 site across 1 country: United Kingdom