Clinical trial NCT00634504: Open-label Leucovorin Pharmacokinetic Study in Patients Receiving High Dose Methotrexate With or Without Voraxaze
Official title: An Open-Label Study to Assess the Pharmacokinetics of Leucovorin in Patients Receiving High Dose Methotrexate, With or Without Voraxaze Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteosarcoma
Leukemia
Lymphoma
Keywords: high dose methotrexate
Voraxaze
leucovorin
delayed elimination
methotrexate toxicity
rescue
renal insufficiency
Lead sponsor: BTG International Inc.
Sponsor class: OTHER
First posted: 2008-03-13
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate whether the administration of Voraxaze reduces exposure to leucovorin and its active metabolite to below the level achieved in patients who have not received Voraxaze.


Eligibility criteria: Inclusion Criteria:

* Receiving High-dose methotrexate (HDMTX) with or without risk of methotrexate (MTX) toxicity, impaired renal function, and delayed MTX elimination
* Require intravenous leucovorin

Exclusion Criteria:

* Arm A only: allergic reactions to lactose
* Arm A only: hereditary fructose or galactose intolerance
* Arm B only: delayed elimination of MTX

Primary outcomes:
measure: Pharmacokinetics (PK) of Leucovorin
timeFrame: 5 minutes, 30 minutes, 1 hour, 2 hours and 3 hours post-LV administration
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Children's Hospital
state: Arizona
city: Los Angeles
country: United States
facility: Good Samaritan Hospital
state: California
city: Los Angeles
country: United States
facility: Children's Hospital of Los Angeles
state: California
city: Los Angeles
country: United States
facility: Children's Hospital of Orange County
state: California
city: Oakland
country: United States
facility: Oakland's Children's Hospital
state: California
city: Palo Alto
country: United States
facility: Stanford University Medical Center & Lucile Packard Children's Hospital
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
city: Aurora
country: United States
facility: Children's Hospital for Cancer & Blood Disorders
state: Colorado
city: Tampa
country: United States
facility: St. Joseph's Hospital
state: Florida
city: Evanston
country: United States
facility: NorthShore University Health System
state: Illinois
city: Indianapolis
country: United States
facility: Riley Hospital for Children
state: Indiana
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Worcester
country: United States
facility: University of Massachusetts - Umass Memorial Medical Center
state: Massachusetts
city: Jackson
country: United States
facility: University of MS Medical Center
state: Mississippi
city: Columbia
country: United States
facility: University of Missouri-Columbia
state: Missouri
city: Saint Louis
country: United States
facility: Washington University Medical Center
state: Missouri
city: Lincoln
country: United States
facility: St. Elizabeth Regional Medical Center
state: Nebraska
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Greenville
country: United States
facility: ECU Brody School of Medicine
state: North Carolina
city: Canton
country: United States
facility: Gabrail Cancer Center
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Center
state: Utah
city: Seattle
country: United States
facility: Children's Hospital and Regional Medical Center
state: Washington
Study officials:
name: Andrew Saunders, MD
role: STUDY_CHAIR
affiliation: BTG International Inc.
name: Suzanne Kincaid, CCRA
role: STUDY_DIRECTOR
References: