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

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Supportive care	Closed	15 and over		MRC-LEUK-IFI EU-97030, NCT00003315

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.

Entry Criteria

Disease Characteristics:

Patients entered into MRC-LEUK-AML11, AML12, UKALLXII, or their successors
(including those undergoing bone marrow transplantation as part of the
studies) who have a proven or suspected deep-seated fungal infection as listed
below:
 Pulmonary fungal infection  - proven or suspected
 Sinus infection - proven or suspected
 Fungemia - proven
 Chronic hepatosplenic candidosis - proven by CT/MRI
 Invasive cutaneous fungal infection - proven
 Cerebral fungal infection - proven or suspected

Prior/Concurrent Therapy:

Biologic therapy:
 At least 3 months since sargramostim

Chemotherapy:
 Not specified

Endocrine therapy:
 Not specified

Radiotherapy:
 Not specified

Surgery:
 Not specified

Other:
 At least 2 weeks since liposomal amphotericin B

Patient Characteristics:

Age:
 15 and over

Performance status:
 Karnofsky 30-100%

Life expectancy:
 At least 6 weeks

Hematopoietic:
 Not specified

Hepatic:
 Not specified

Renal:
 Not specified

Other:
 No known intolerance to liposomal amphotericin B or sargramostim

Expected Enrollment

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 physician's discretion.

Patients are assessed weekly until the end of study (particularly on day 28 
and at end of study).

Trial Contact Information

Trial Lead Organizations

Medical Research Council's Working Party on Leukemia in Adults and Children

C.H. Poynton, MD, Protocol chair		Ph: 44-29-2074-2654 Email: poynton@cardiff.ac.uk

Registry Information
Official Title		Supplementary Protocol for Patients With Invasive Fungal Infection, Entered Into AML 11, AML 12 and UKALL XII (Or Their Successors)
Trial Start Date		1997-07-01
Registered in ClinicalTrials.gov		NCT00003315
Date Submitted to PDQ		1998-05-07
Information Last Verified		2007-05-21

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