MT2013-37R: Voriconazole Monitoring in Pediatric Stem Cell Transplant Patients

Sponsor

Masonic Cancer Center, University of Minnesota (Other)

Overall Status

Completed

CT.gov ID

NCT02227797

Collaborator

(none)

Enrollment

Location

Arm

49.3

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary purpose of this study is to identify the optimal dose of voriconazole, an anti-fungal drug often used in people undergoing stem cell transplant. An optimal dose level is one level that provides a good blood level (concentration) of voriconazole without too much toxicity.

Condition or Disease	Intervention/Treatment	Phase
Fungal Infection	Drug: Voriconazole	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

66 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

MT2013-37R: Voriconazole Therapeutic Drug Monitoring in Pediatric Hematopoietic Stem Cell Transplant Patients

Actual Study Start Date :

Jan 19, 2015

Actual Primary Completion Date :

Sep 8, 2017

Actual Study Completion Date :

Mar 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Voriconazole	Drug: Voriconazole 6 mg/kg to 12 mg/kg IV/PO every 12 hours depending on patient age and dose toleration of prior patients

Arm

Intervention/Treatment

Experimental: Voriconazole

Drug: Voriconazole

6 mg/kg to 12 mg/kg IV/PO every 12 hours depending on patient age and dose toleration of prior patients

Outcome Measures

Primary Outcome Measures

Maximum tolerated, minimum efficacious dose for 3 different pediatric age groups [Seven days after starting voriconazole]

Secondary Outcome Measures

Correlation of initial dose of voriconazole with voriconazole blood concentration in 3 different pediatric age groups [After starting voriconazole: Day 5, between Days 12-15, between Days 19-22]
Correlation of voriconazole dose with elevations to 5 times the upper limit of normal in liver enzymes [After starting voriconazole: Twice a week Days 1-30 and 1 week after the last dose of voriconazole ~ Day 35-42]
Incidence of fungal infection [6-month period after transplant]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 21 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Any patient undergoing allogeneic hematopoietic stem cell transplantation (either 1st or subsequent)
Age ≤ 21 years
Adequate organ function within 14 days of enrollment, i.e. Creatinine: < 1.5 x ULN and Hepatic: ALT, AST and total bilirubin < 3 x ULN
Requires voriconazole to prevent or treat invasive fungal infection after undergoing stem cell transplantation

Exclusion Criteria:

Has received voriconazole within 5 days prior to starting study therapy
History of hypersensitivity or severe intolerance to azoles
History, or current evidence, of cardiac arrhythmias defined as QTc ≥ 480 mm/sec
Receiving the following drugs and cannot be discontinued at least 24 hours before starting therapy: pimozide, quinidine, astemizole, ergot alkaloids.
Received one or more of the following drugs within 14 days prior to starting study, as they are potent inducers of hepatic microsomal enzymes: rifampin, rifabutin, carbamazepine, phenytoin, nevirapine, long-acting barbiturates.
Received sirolimus within the 14 days prior to starting study as voriconazole is a potent inhibitor of sirolimus metabolism
Receiving or anticipated need for methadone as co-administration with voriconazole potentially increases methadone exposure

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Minnesota Medical Center, Fairview	Minneapolis	Minnesota	United States	55455

Sponsors and Collaborators

Masonic Cancer Center, University of Minnesota

Investigators

Principal Investigator: Angela Smith, M.D., Masonic Cancer Center, University of Minnesota
Principal Investigator: Pui-Yang Iroh Tam, M.D., Masonic Cancer Center, Univeristy of Minnesota