Neoplasms
Conditions
Keywords
methotrexate, delayed elimination, renal insufficiency, CPG2, Voraxaze
Brief summary
To evaluate the safety and efficacy of glucarpidase in patients with impaired methotrexate (MTX) clearance owing to MTX-induced renal failure following high-dose MTX therapy, or with intrathecal MTX overdose.
Interventions
DRUGglucarpidase (50 Units/kg)
Sponsors
BTG International Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Written informed consent by patient or legally valid representative * Patients receiving high-dose MTX (\>1 g/m2 body surface area (BSA) given as an infusion over 24 hours) for the treatment of ALL, NHL or a solid tumour (e.g. osteosarcoma) * Age ≥ 18 years * Serum MTX \>5 µmol/L 42 hours or later after the start of MTX infusion, or serum MTX \>1 μmol/L 42 hours or later after the start of MTX infusion together with renal insufficiency, or serum MTX \>0.4 µmol/L 48 hours or later after the start of MTX infusion together with renal insufficiency. Renal insufficiency was defined as serum creatinine \>1.5 × the upper limit of normal (ULN) and/or oliguria (urine output \< 500 mL/24 hours despite adequate hydration, diuretics and alkalinisation).
Exclusion criteria
* Pregnant or lactating females * Unwillingness of patient or relative/legal representative to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in serum MTX concentration | — |
Secondary
| Measure | Time frame |
|---|---|
| serum creatinine | — |
| creatinine clearance | — |
| haematology (complete blood count and differential) | — |
| biochemistry (electrolytes, SGOT, SGPT, alkaline phosphatase, bilirubin, total protein) | — |
| serum blood-urea-nitrogen | — |
| MTX-related toxicity | — |
| Adverse events | — |
| Mortality | — |
| urinalysis (dip-stick) | — |
Countries
Germany
Outcome results
None listed