Study of Glucarpidase (CPG2) for the Management of Patients With Delayed Methotrexate Clearance
Phase 2
Completed
- Conditions
- Neoplasms
- Registration Number
- NCT00219791
- Lead Sponsor
- BTG International Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Reduction in serum MTX concentration
- Secondary Outcome Measures
Name Time Method Mortality serum blood-urea-nitrogen serum creatinine creatinine clearance haematology (complete blood count and differential) biochemistry (electrolytes, SGOT, SGPT, alkaline phosphatase, bilirubin, total protein) urinalysis (dip-stick) MTX-related toxicity Adverse events
Trial Locations
- Locations (1)
Charite - Universitätsmedizin Berlin
🇩🇪Berlin, Germany