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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003315
First received: November 1, 1999
Last updated: December 3, 2013
Last verified: May 2007
  Purpose

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.


Condition Intervention Phase
Infection
Biological: sargramostim
Drug: liposomal amphotericin B
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Supportive Care
Official Title: Supplementary Protocol for Patients With Invasive Fungal Infection, Entered Into AML 11, AML 12 and UKALL XII (Or Their Successors)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 200
Study Start Date: July 1997
Study Completion Date: December 1997
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.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003315

Locations
United Kingdom
University of Wales College of Medicine
Cardiff, Wales, United Kingdom, CF4 4XN
Sponsors and Collaborators
Medical Research Council
Investigators
Study Chair: C.H. Poynton, MD University Hospital of Wales
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00003315     History of Changes
Other Study ID Numbers: CDR0000066264, MRC-LEUK-IFI, EU-97030
Study First Received: November 1, 1999
Last Updated: December 3, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
infection

Additional relevant MeSH terms:
Mycoses
Amphotericin B
Liposomal amphotericin B
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on July 29, 2014