Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003315
Status:
COMPLETED
Last Update Posted:
2013-12-04
First Post:
1999-11-01
Brief Title:
Liposomal Amphotericin B With or Without Sargramostim in Treating Patients With Invasive Fungal Infection
Sponsor:
Medical Research Council
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Supplementary Protocol for Patients With Invasive Fungal Infection Entered Into AML 11 AML 12 and UKALL XII Or Their Successors
Status:
COMPLETED
Status Verified Date:
2007-05
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 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 persons 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
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 physicians 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
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 physicians 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
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 |
|---|---|---|---|
| EU-97030 | None | None | None |
| MRC-LEUK-IFI | None | None | None |