Study of Glucarpidase (CPG2) for the Management of Patients With Delayed Methotrexate Clearance

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00219791
• Other study ID #: PR001-CLN-rpt002
• Secondary ID: ek.179-6
• Status: Completed
• Phase: Phase 2
• First received: September 15, 2005
• Last updated: September 10, 2014
• Start date: January 2000
• Est. completion date: June 2003

Study information

• Verified date: September 2014
• Source: BTG International Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: June 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• glucarpidase (50 Units/kg)

Locations

Country	Name	City	State
Germany	Charite - Universitätsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
BTG International Inc.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in serum MTX concentration
Secondary	serum blood-urea-nitrogen
Secondary	serum creatinine
Secondary	creatinine clearance
Secondary	haematology (complete blood count and differential)
Secondary	biochemistry (electrolytes, SGOT, SGPT, alkaline phosphatase, bilirubin, total protein)
Secondary	urinalysis (dip-stick)
Secondary	MTX-related toxicity
Secondary	Adverse events
Secondary	Mortality