NCT00003315

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 1997

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1997

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 1997

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4.8 years until next milestone

First Posted

Study publicly available on registry

August 26, 2004

Completed
Last Updated

December 4, 2013

Status Verified

May 1, 2007

First QC Date

November 1, 1999

Last Update Submit

December 3, 2013

Conditions

Infection

Keywords

infection

Interventions

sargramostimBIOLOGICAL
liposomal amphotericin BDRUG

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Wales College of Medicine

Cardiff, Wales, CF4 4XN, United Kingdom

Location

MeSH Terms

Conditions

Infections

Interventions

sargramostimliposomal amphotericin B

Study Officials

  • C.H. Poynton, MD

    University Hospital of Wales

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
SUPPORTIVE CARE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 1, 1999

First Posted

August 26, 2004

Study Start

July 1, 1997

Study Completion

December 1, 1997

Last Updated

December 4, 2013

Record last verified: 2007-05

Locations

GB(1)