Status:
COMPLETED
Study of Glucarpidase (CPG2) for the Management of Patients With Delayed Methotrexate Clearance
Lead Sponsor:
BTG International Inc.
Conditions:
Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 o...
Eligibility Criteria
Inclusion
- 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
- Pregnant or lactating females
- Unwillingness of patient or relative/legal representative to give informed consent
Key Trial Info
Start Date :
January 1 2000
Trial Type :
INTERVENTIONAL
End Date :
June 1 2003
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00219791
Start Date
January 1 2000
End Date
June 1 2003
Last Update
September 11 2014
Active Locations (1)
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1
Charite - Universitätsmedizin Berlin
Berlin, Germany, 12200