Trial | NCT00219791  Report issue

Title

Study of Glucarpidase (CPG2) for the Management of Patients With Delayed Methotrexate Clearance
Study of Recombinant Carboxypeptidase G2 (CPG2) for the Management of Patients With Delayed Methotrexate (MTX) Clearance or Intrathecal MTX Overdosage

  • Phase

    Phase 2

  • Lead Sponsor

    BTG

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    glucarpidase ...

  • Study Participants

    None
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.
Study Started
Jan 31
2000
Study Completion
Jun 30
2003
Last Update
Sep 11
2014
Estimate

Drug glucarpidase (50 Units/kg)

Criteria 

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
No Results Posted