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

Primary Purpose

Infection

Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
sargramostim
liposomal amphotericin B
Sponsored by
Medical Research Council
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Infection focused on measuring infection

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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 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

Sites / Locations

  • University of Wales College of Medicine

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
December 3, 2013
Sponsor
Medical Research Council
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1. Study Identification

Unique Protocol Identification Number
NCT00003315
Brief Title
Liposomal Amphotericin B With or Without Sargramostim in Treating Patients With Invasive Fungal Infection
Official Title
Supplementary Protocol for Patients With Invasive Fungal Infection, Entered Into AML 11, AML 12 and UKALL XII (Or Their Successors)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
July 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 1997 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Medical Research Council

4. Oversight

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection
Keywords
infection

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
sargramostim
Intervention Type
Drug
Intervention Name(s)
liposomal amphotericin B

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility 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 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
C.H. Poynton, MD
Organizational Affiliation
University Hospital of Wales
Official's Role
Study Chair
Facility Information:
Facility Name
University of Wales College of Medicine
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF4 4XN
Country
United Kingdom

12. IPD Sharing Statement

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

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