Liposomal Amphotericin B With or Without Sargramostim in Treating Patients

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00003315
Study type	Interventional
Source	National Cancer Institute (NCI)
Contact
Status	Completed
Phase	Phase 3
Start date	July 1997
Completion date	December 1997

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04529421` - Assocation Between In-person Instruction and COVID-19 Risk
Recruiting	`NCT04081792` - Optimal Antibiotics for Operated Diabetic Foot Infections	N/A
Completed	`NCT04332861` - Evaluation of Infection in Obstructing Urolithiasis
Recruiting	`NCT04674657` - Does Extra-Corporeal Membrane Oxygenation Alter Antiinfectives Therapy Pharmacokinetics in Critically Ill Patients
Enrolling by invitation	`NCT05052203` - Researching the Effects of Sepsis on Quality Of Life, Vitality, Epigenome and Gene Expression During RecoverY From Sepsis
Recruiting	`NCT00342589` - New Techniques for Using a Saline Wash as a Diagnostic Tool for Pneumocystis Pneumonia
Completed	`NCT03295825` - Heparin Binding Protein in Early Sepsis Diagnosis	N/A
Completed	`NCT03296423` - Bacillus Calmette-guérin Vaccination to Prevent Infections of the Elderly	Phase 4
Withdrawn	`NCT04217252` - Clinical Application of High-throughput Sequencing Technology for the Diagnosis of Patients With Severe Infection	N/A
Recruiting	`NCT02899143` - Short-course Antimicrobial Therapy in Sepsis	Phase 2
Recruiting	`NCT02905552` - Myelodysplasic Syndromes and Risk Factors for Infection	N/A
Withdrawn	`NCT02904434` - Gastrointestinal Implications of Voriconazole Exposure
Active, not recruiting	`NCT02768454` - Antimicrobials Stewardship by Pharmacist	N/A
Completed	`NCT02219776` - Decreasing Infection In Arthroscopic Shoulder Surgery	N/A
Completed	`NCT02210169` - RCT of Continuous Versus Intermittent Infusion of Vancomycin in Neonates	N/A
Recruiting	`NCT02098226` - Evaluation of MALDI Biotyper CA System for Detection of Gram- and Gram+ Bacteria and Yeasts	N/A
Completed	`NCT01846832` - A Study of TMC435 Plus Pegylated Interferon Alfa-2a and Ribavirin in Participants With Chronic HCV Infection	Phase 3
Terminated	`NCT01441206` - Safety and Pharmacokinetics of Single and Multiple Dose Rifampin in Infants	Phase 1
Completed	`NCT01434797` - Value of PET/CT Imaging in the Diagnosis of Permanent Central Venous Catheters Infection
Completed	`NCT01159834` - Human Papillomavirus (HPV) Vaccination in Barretos (Pio XII Foundation - Barretos Cancer Hospital)	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms