InfectionPhase 3NCT00003315

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

A Phase 3 study testing sargramostim and liposomal amphotericin B in people with Infection, run by Medical Research Council at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 15 years and older
Conditions the study is for: Infection
What is being tested?: sargramostim and liposomal amphotericin B
How many people: 200 participants
Where: 1 siteUnited Kingdom
Study dates: Jul 1997to Dec 1997
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 15 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

University of Wales College of Medicine
Cardiff, Wales, CF4 4XN

Other trials in United Kingdom

About this study

Official title: Supplementary Protocol for Patients With Invasive Fungal Infection, Entered Into AML 11, AML 12 and UKALL XII (Or Their Successors)

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.

Read the 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.

Conditions: Infection
Being tested: sargramostim, liposomal amphotericin B
Keywords: infection
Medical subject headings: Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

sargramostimBiological
liposomal amphotericin BDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 1997Dec 1997

First posted26 Aug 2004 (estimated)
Study startJul 1997
Study completionDec 1997

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for InfectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Supportive care
Allocation: Randomised
Enrolment: 200 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00003315
Sponsor's protocol ID: CDR0000066264
Other IDs: MRC-LEUK-IFI, EU-97030
Status last verified: May 2007
First submitted: 1 Nov 1999
Last updated: 4 Dec 2013
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 4 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Supplementary Protocol for Patients With Invasive Fungal Infection, Entered Into AML 11, AML 12 and UKALL XII (Or Their Successors)
ClinicalTrials.gov ID: NCT00003315
Acronym / sponsor ID: CDR0000066264
Conditions: Infection
Keywords: infection
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 200 participants (estimated)
Lead sponsor: Medical Research CouncilOther government
Study start: Jul 1997
Study completion: Dec 1997 (actual)
First posted: 26 Aug 2004 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

PROJECTED ACCRUAL: There will be 200 patients (100 in each arm) accrued into this study.

Study design

Primary purpose: Supportive care
Allocation: Randomised

Who may qualify

Ages: 15 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
sargramostim	Biological	–
liposomal amphotericin B	Drug	–

Primary outcome

Not reported in the source record.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2013.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

C.H. Poynton, MD study chair

University Hospital of Wales

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing sargramostim and liposomal amphotericin B in people with Infection, run by Medical Research Council at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00003315.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2013.