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


Phase 2
18 Years
N/A
Not Enrolling
Both
Neoplasms

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Reduction in serum MTX concentration

Principal Investigator

Thiel Eckhard, Prof. Dr.med.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Charite - Universitätsmedizin Berlin

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

PR001-CLN-rpt002

NCT ID:

NCT00219791

Start Date:

January 2000

Completion Date:

June 2003

Related Keywords:

  • Neoplasms
  • methotrexate
  • delayed elimination
  • renal insufficiency
  • CPG2
  • Voraxaze
  • Neoplasms

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